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Diagnostics antibodies and antigens for infectious disease detection


It is important to diagnose the infectious disease even before it becomes serious. The traditional pathogen-detection methods, such as culture, have established their credibility over time, they are often slow and relatively insensitive. In addition, there are several emerging infectious diseases (ID) such as dengue fever, zika virus, corona virus and so on are need to be diagnosed immediately to prevent the outbreak. Immunodiagnostics show great promise than the traditional methods used in clinical diagnosis. GENEMEDI developed the antigens and antibodies for rapid kit such as ELISA, Lateral flow immunoassay (LFIA), colloidal gold immunochromatographic assay, Chemiluminescent immunoassay (CLIA), turbidimetric inhibition immuno assay (TINIA), immunonephelometry and POCT to detect the different types of infectious disease.

Classification: Flu A Flu B HIV-1 HIV-2 HIV1/2 HIV-O HCV Treponema Pallidum T. gondii rubella virus Cytomegalovirus HSV HSV-1 HSV-2 B. anthracis Ebola virus Vaccinia virus (cowpox virus) West Nile virus Adenovirus Plasmodium Astrovirus Norovirus C. jejuni L. monocytogenes Rotavirus Salmonella typhi C. albicans HPV HBV HBV-PreS1 Food source pathogenic bacteria resistant Rift Valley Fever EBV V. cholerae M. tuberculosis Cryptosporidium parvum (Cp23 ) RSV Rhinoviruses dengue nonstructural 1 (DEN-NS1) Enterovirus streptolysin O Mycoplasma pneumoniae Helicobacter pylori Prion STDs ARTI SARS-CoV2 Ribavirin(RBV) Amantadine(AM)





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GeneMedi and other company's P24 antibody pairs validation with HIV PSV in sandwich ELISA

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Figure. GeneMedi and other company’s P24 antibody pairs validation with HIV PSV (GMVP-LVc10) in sandwich ELISA. GeneMedi's P24 antibody pair has a larger linear range and better sensitivity, and represents the best EC50. GeneMedi’s Ab01: GMP-IVD-P003-Tg001-Ab01, GeneMedi’s Ab02: GMP-IVD-P003-Tg001-Ab02.

Abstract

Infectious diseases are a significant burden on public health and economic stability of societies all over the world. They have been among the leading causes of death and disability and presented growing challenges to health security and human progress for centuries. Infectious diseases are generally caused by microorganisms. The routes of them entry into host is mostly by the mouth, eyes, genital openings, nose, and the skin. Damage to tissues mainly results from the growth and metabolic processes of infectious agents intracellular or within body fluids, with the production and release of toxins or enzymes that interfere with the normal functions of organs and/or systems [1]. Advances in basic science research and development of molecular technology and diagnostics have enhanced understanding of disease etiology, pathogenesis, and molecular epidemiology, which provide basis for appropriate detection, prevention, and control measures as well as rational design of vaccine [2]. The diagnosis of infectious diseases is particularly critical for the prevention and control of the epidemic. Here we introduce the insights and detection methods of infectious disease, aiming to provide some helps for clinical diagnosis as well as epidemic prevention and control of infectious diseases.

1. Introduction of human infectious diseases caused by living pathogens

Infectious diseases arise upon contact with an infectious agent. Five major infectious agents have been identified: bacteria, viruses, fungi, protozoans and parasites [3, 4]. Various factors can be identified that create opportunities for infectious agents to invade human hosts. These include global urbanization, increase in population density, poverty, social unrest, travel, land clearance, farming, hunting, keeping domestic pets, deforestation, climate change, and other human activities that destroy microbial habitat [5, 6]. Human engagement in activities that interfere with ecological and environmental conditions continues, thereby increasing the risk of contact with new pathogens. These pathogens are mostly transmitted though intermediate animal hosts such as rodents [7, 8], which gain increased contact with humans as a result of environmental and human behavioral factors. In most cases, a combination of risk factors accounts for infectious disease emergence and/or outbreak of epidemic. Here we list some past emerging infectious disease epidemics and probable factors for the outbreak in Table 1.

Table1. Some past infectious disease epidemics and possible outbreak factors
Year  Emerging disease  Pathogenic agent  Main probable factor Genemedi's Diagnostics antibodies and antigens
2019 2019-novel-coronavirus pneumonia 2019-nCoV/SARS-CoV-2 Dynamic balances and imbalances, within complex globally distributed ecosystems comprising humans, animals, pathogens, and the environment. May be because of hunting and feeding on infected wild animals (viverrids) Antigens: Nucleocapsid (N protein), Spike(S protein), RBD, S1+S2 ECD, Envelope (E protein), 3C-like Proteinase (Mpro), RdRP(Nsp12), etc.
Antibodies: N protein antibody (

GMP-V-2019nCoV-NAb001~004) , Spike protein antibody (

GMP-V-2019nCoV-SAb001~004)

1976-2020 Ebola haemorrhagic fever Filovirus Ebola virus Rainforest penetration by humans/close
contact with infected game (hunting) or
with host reservoirs (bats)/infected
biological products/nosocomial/needle
spread 		Antibodies: Anti-ebola virus (EV) nucleoprotein (NP) mouse monoclonal antibody (mAb)
Antigens: Recombinant ebola virus (EV) nucleoprotein (NP) Protein
1889, 1890,
1918, 1957 		Pandemic Influenza Paramyxovirus influenza A Animal-human virus reassortment and
antigenic shift 		Antibodies: Anti-Influenza A NP mouse monoclonal antibody
Antigens: Recombinant Influenza A NP Protein (Flu A/B, His Tag)
2003 Severe acute respiratory syndrome (SARS) SARS Coronavirus Hunting and feeding on infected wild
animals (viverrids)
1997 Highly pathogenic avian influenza (HPAI) H5N1 virus Animal-animal influenza virus gene
reassortment; emergence of H5N1 avian
influenza, extensive chicken farming 		Antibodies: Anti-Avian Influenza Virus Type A H5N1 subtype Nucleocapsid Protein (NP) mouse monoclonal antibody (mAb)
Anti-Avian Influenza Virus Type A H5N1 subtype Haemagglutinin (HA) mouse monoclonal antibody (mAb)
Antigens: Recombinant Avian Influenza Virus Type A H5N1 subtype NP Protein
Recombinant Avian Influenza Virus Type A H5N1 subtype Haemagglutinin (HA) Protein
1996 Haemorrhagic colitis Escherichia coli O157:H7 Ingestion of contaminated food,
undercooked beef, and raw milk
1988 Herpes Herpes simplex virus 1/2(HSV-1/HSV-2) Indirect contact transmission, saliva, liquid from herpes, blood,mother to baby at birth. Antibodies: Anti-herpes simplex virus (HSV) mouse monoclonal antibody (mAb)
Antigens: Recombinant herpes simplex virus (HSV) Protein
1987 Rift Valley fever (RVF) Bunyavirus RVF virus Dramatic increase in mosquito vector
breeding sites (by dam filling); weather
(rainfall) and cattle migration (guided by
artificial water holes) 		Antibodies: Anti-Rift Valley Fever (RVF) nucleoprotein (NP) mouse monoclonal antibody (mAb)
Antigens: Recombinant Rift Valley Fever (RVF) nucleoprotein (NP) Protein
1987 Hepatitis C Hepatitis c virus (HCV) Blood, acupuncture, drug taking, etc Antibodies: Anti-hepatitis C virus (HCV) Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) mouse monoclonal antibody (mAb)
Antigens: Recombinant hepatitis C virus (HCV) Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) Protein
1983 Crimean-Congo haemorrhagic fever CCHF virus Ecological changes favouring increased
human exposure to ticks of sheep and
small wild animals
1981 Acquired immunodeficiency syndrome (AIDS) Human immunodeficiency virus (HIV) Sexual contact/exposure to blood or
tissues of an infected person 		Antibodies: Anti-Human immunodeficiency virus 1 (HIV-1) GP41 Protein mouse monoclonal antibody (mAb)
Antigens: Recombinant Human immunodeficiency virus 1 (HIV-1) GP41 Protein Protein
1976 Malaria Plasmodium falciparum Human behaviour/rainfall and drainage
problems/mosquito breeding/neglect of
eradication policy, economics, and
growing interchange of populations 		Antigens: Recombinant Plasmodium merozoite surface protein (MSP) Protein
Recombinant Plasmodium Circumsporozoite Protein (CSP) Protein
Antibodies: Anti-Plasmodium merozoite surface protein (MSP) mouse monoclonal antibody (mAb)
Anti-Plasmodium Circumsporozoite Protein (CSP) mouse monoclonal antibody (mAb)
1969 Lassa fever Arenavirus Lassa virus Hospital exposure to index case—rodent
exposure
1965 Hepatitis B Hepatitis b virus (HBV) sexual contact, sharing needles, syringes, or other drug-injection equipment, mother to baby at birth. Antigens: Recombinant Hepatitis b virus (HBV) HBsAg Protein
Recombinant Hepatitis B virus (HBV) HBeAg Protein
Recombinant Hepatitis B virus (HBV) HBcAg Protein
Antibodies: Anti-Hepatitis B virus (HBV) HBsAg mouse monoclonal antibody (mAb)
Anti-Hepatitis B virus (HBV) HBeAg mouse monoclonal antibody (mAb)
Anti-Hepatitis B virus (HBV) HBcAg mouse monoclonal antibody (mAb)
1959 Bolivian haemorrhagic fever (BHF) ArenavirusMachupo virus Population increase of rats gathering food
1958 Argentine haemorrhagic fever  ArenavirusJunin virus  Changes in agricultural practices of corn harvest (maize mechanization)
1953 Dengue haemorrhagic fever (DHF) Dengue viruses 1, 2, 3, and 4 Increasing human population density in
cities in a way that favours vector
breeding sites (water storage)
1949 Cervical cancer Human papilloma virus (HPV) Contact infection, Sexual contact Antibodies: Recombinant Human papilloma virus (HPV) HPV 16 L1 capsid protein Protein
Antibodies: Anti-Human papilloma virus (HPV) HPV 16 L1 capsid protein mouse monoclonal antibody (mAb)

2. The strategies used in diagnosis of human Infectious diseases


2.1 Molecular Methods


The development of molecular methods for the direct identification of a specific viral genome from the clinical sample is one of the greatest achievements of the 21st century. Clearly nucleic acid amplification techniques including Reverse Transcription-Polymerase Chain Reaction (RT-PCR), nucleic acid sequence-based amplification (NASBA) and Lawrence Livermore Microbial Detection Array (LMDA) are proven technology leaders for rapid detection and molecular identification for most known human viruses [9].

RT-PCR assays for virus detection provides faster results than end-point assays and in many cases have sensitivities equal to or better than culture [10]. The novel coronavirus, 2019-nCoV, was detected through real-time RT-PCR with primers against two segments of its RNA genome [11]. The particular primer sets and specific guideline for detection of COVID-19 through RT-PCR were made available by the Center for Disease Control (CDC) USA, according to CDC [12]. However, high mutation rates may lead to extensive changes in viral nucleic acid sequences making dedicated PCR primer use irrelevant, therefore there is high demand for the development of rapid and universal virus identification and detection technologies. In contrast, although NASBA assay is considered sensitive; it has not been widely used because of the difficulties in the preparation of NASBA master mix in-house and the high cost of commercial kits. A new molecular biology-based microbial detection method for rapid identification of multiple virus types in the same sample has been developed by a research group at Lawrence Livermore National Laboratory. Lawrence Livermore Microbial Detection Array (LLMDA) detects viruses using probes against genomic DNA sequence within 24 hours [13,14]. In addition, the oligonucleotide probes were selected to enable detection of novel, divergent species with homology to sequenced organisms [14].

Picture loading failed. Figure 1. Principle of RT-PCR.

2.2 Immuno-assays


The nucleic acid Diagnostics tool currently employed is with good sensitivity and excellent specificity. However, due to its high false negative, time-consuming, high level equipment and technical personnel demand, the immunological antigen or antibody detection has been paid more and more attention because of its quick detection speed, low and simple technical requirements of detection. At present, the detection methods mainly include Enzyme-linked immunosorbent assays (ELISAs), colloidal gold immunochromatography (GICA) and magnetic particle chemiluminescence.

2.2.1 Enzyme-Linked Immunosorbent Assays (ELISA)

Enzyme-linked immunosorbent assays (ELISAs) incorporate the sensitivity of simple enzyme assays with the specificity of antibodies, by employing antigens or antibodies coupled to an easily-assayed enzyme. As such ELISA is much more rapid method than immunoblotting to detect specific viral protein from a cell, tissue, organ, or body fluid. There are two main variations of ELISAs: antigen-capture ELISA (detecting viral proteins), involve attachment of a capture antibody to a solid matrix for the viral protein of interest, while antibody-capture ELISA measures the specific antibody level in a sample, by coating viral antigen protein on a solid surface. There are two principles based on antigen-capture and antibody-capture ELISAs. In a general, ELISAs are considered a highly sensitive method that can detect a fairly low number of proteins at the range of picomolar to nanomolar range (10-12 to 10-9 moles per liter). ELISA has been one of the most widely used serologic tests for detecting antibody to HIV-1. ELISA method was found useful as a Diagnostics tool to detect influenza viral antigen much quicker than other conventional virus detection methods [15]. In another previous study, comparison of ELISA, with conventional methods has demonstrated ELISA superiority for the rapid detection and identification of influenza A virus [16]. A simplified and standardized neutralization enzyme immunoassay (Nt-EIA) was developed to detect measles virus growth in Vero cells and to quantify measles neutralizing antibody [17]. Newer EIA formats for hepatitis C virus diagnostics have been constantly evaluated [18,19]. As such ELISAs are being used for plethora of application both in experimental and Diagnostics virology including HIV-1, dengue, and influenza [20-22]. On the other hand, although rapid than traditional plaque assays or TCID50, ELISA assays sometimes could be quite expensive, due to the cost of reagents used. Unfortunately, sometimes required antibodies may not be commercially developed as well. In contrast, attempts to develop antibodies in-house may be quite expensive. Additional variability may also be introduced due to high background signals generated by non-specific binding, or cross-reactivity with non-viral protein targets.

Picture loading failed. Figure 2. A schematic representation of two principles based on antigen or antibody capture ELISA[23]

2.2.2 Colloidal gold immunochromatography (GICA)

Based on the specific immune response of antigen and antibody, colloidal gold particles were used as one of the tracer markers. Driven by solvent chromatography, the markers had an immune response on the C/T line, and the detection results could be obtained according to the color of the T line. GICA samples can be whole blood, serum or plasma, and studies have shown that the colloidal gold reagent has a high consistency in detecting whole blood, plasma or serum [24]. At present, there are seven kinds of colloidal gold kits approved by the State Food and Drug Administration, which are all detection antibodies, but there is no detection kit for antigens. RT-PCR was used as the control method, and the sensitivity and specificity of IgM/IgG antibody were different, and the highest detection rate of the two combined detection was 66.1% (125/189) [25]. This method can be used for enterprise resumption, students return to school, community crowd screening and other scenarios. Only a drop of fingertip blood is needed, and the detection results can be observed visually in 15 minutes, which is rapid and simple without special instruments. However, the detection has its disadvantages such as window period, without quantification, exposure risk, low sensitivity and vulnerability to environmental factors, and nucleic acid detection combination result is required for verification.

Picture loading failed. Figure 3. Scheme showing the general steps in the antibody-based diagnosis of viral infections from blood samples[26]

2.2.3 Magnetic particle chemiluminescence

Magnetic particle chemiluminescence is an emerging technique to capture specific IgM/IgG antibodies in samples using magnetic particles fixed on the surface of recombinant antigens. The antigen-antibody complex was precipitated by external magnetic field, and the captured antigen-antibody complex was identified by enzyme-labeled secondary antibody, and the luminescent intensity was determined by chemiluminescence instrument after adding the luminescent agent, and then quantitative analysis was carried out. It is characterized by high sensitivity, high specificity and wide detection range, etc. There are currently seven approved magnetic particle chemiluminescence detection kits, the first one developed by Bioscience, with an automatic chemiluminescence analyzer, capable of detecting at a speed of 240 T/H with an initial reporting time of 30 min [27].

2.3 Viral Culture


Virus culture, isolation and identification are the gold standards for laboratory identification of pathogens. However, viral culture results do not yield timely results to inform clinical management. Shell-vial tissue culture results may take 1-3 days, while traditional tissue-cell viral culture results may take 3-10 days. Due to the long incubation time, high technical requirements, and must be carried out in a level III safe biological laboratory, it is not suitable for rapid virus diagnosis during the epidemic period [28].

2.4 Immunofluorescence (IF) Assay


Immunofluorescence (IF) technique is widely used for rapid detection of virus infections by identifying virus antigens in clinical specimens. IF staining is usually considered very rapid (about 1 to 2 hr) and overall gives a sensitive and specific viral identification [29-32]. Unfortunately, IF technique may not able to confirm the identity of all virus strains, for instance viruses of the “enterovirus” group; since most monoclonal antibodies (MAbs) for enteroviral identification have been shown to lack sensitivity, while cross-reactivity with rhinoviruses is extremely common [33]. In contrast, IF has been successfully used for better management of influenza virus infection and surveillance of influenza virus activity [30, 31]. As recommended by CDC, when influenza activity is low, positive results should be confirmed by direct immunofluorescence assay (DFA), viral culture, or RT-PCR, as false positive test results are more likely; while during peak influenza activity confirmatory testing using DFA, viral culture, or PCR must always be considered because a negative test may not rule out influenza viral infection. Interestingly, although IF is generally considered less sensitive then ELISA and PCR, a recent publication reports DFA as an optimal method for rapid identification of varicella-zoster virus (VZV), when compared with conventional cell culture [34]. In contrast, the Herpes simplex virus (HSV) DFA test accuracy was found very low (sensitivity 61%, specificity 99%), when tested to identify mucocutaneous HSV infection in children [35]. Furthermore, a monoclonal antibody designated CHA 437 was developed against HSV showed no cross-reactivity against the varicella-zoster virus, cytomegalovirus, or Epstein-Barr virus, however direct specimen testing resulted in overall low sensitivity (84.6%) and specificity (95.7%) [36]. On the other hand, an antigen detection assay for severe acute respiratory syndrome (SARS) coronavirus (CoV) could detect SARS-CoV in 11 out of 17 (65%) samples from SARS patients. As such IF technique is well-accepted laboratory diagnostics test, however, sometime these assays could be quite expensive, due to the cost of antibodies used. Additional variability may also be introduced due to non-specific binding, or cross-reactivity of commercially available antibodies [37].

As such IF technique is well-accepted laboratory diagnostics test, however, sometime these assays could be quite expensive, due to the cost of antibodies used. Additional variability may also be introduced due to non-specific binding, or cross-reactivity of commercially available antibodies.

Picture loading failed. Figure 4. Immunofluorescence staining of vaccinia virus infected cell [38]. Areas of virus assembly within the cell are pink.
Host and viral DNA (deoxyribonucleic acid) is blue. The host cell's DNA is contained within its nucleus (large oval). Actin protein
filaments, which make up part of the cytoskeleton, are green.

2.5 Immunoblotting (WB)


Immunoblotting technique detects specific viral proteins isolated from a cell, tissue, organ, or body fluid. The development of sensitive and specific tests for human immunodeficiency virus type 1 (HIV-1) progressed rapidly after this retrovirus was found to be responsible for causing AIDS [39]. Immunoblotting has been one of the reference confirmatory tests for the diagnosis of HIV infection or after inconclusive enzyme immunoassay (EIA) results. Although difficulty in interpretation of immunoblotting results and the cost led to a reduction in overall use of WB technique, nevertheless immunoblots are still commonly used for various purposes, including clinical diagnosis of HIV-1, seroprevalence surveys, and for blood-donor screening. In addition, immunoblot assays have been used to confirm the anti-hepatitis C virus (HCV) reactivity [40]. In recent years immunoblotting has been established as an important prerequisite for the functional studies to understand protein composition of the purified viral particles, since it allows the analysis of specific proteins which result in better understanding of the infection process and the pathogenesis of viruses [41,42].

2.6 Transmission Electron Microscopy (TEM)


Most viruses are very small to be seen directly under a light microscope, and therefore could only be viewed with TEM (transmission electron microscopy). In 1948, smallpox and chicken pox were first differentiated by TEM [43] and thereafter early virus classifications depended heavily on TEM analysis. In particular many intestinal viruses were discovered by negative staining TEM microscopy [44, 45]. Although TEM has gradually been replaced by more sensitive methods such as PCR, nevertheless it still remains essential for several aspects of virology including discovery, description and titration of viruses. One of the major advantages of using TEM is that it does not require virus-specific reagents; this is of particular importance in an outbreak setting where the etiologic agent is unknown and therefore specific reagents may not be available to determine correct detection tests. Negative stained TEM technique continues to be a valuable tool for the discovery and identification of novel viruses including Ebola virus, henipavirus (Hendra and Nipah) and SARS [46-50]. A human monkeypox outbreak was detected in the US by TEM [51]. Nevertheless, due to the high instrument cost and the amount of space and facilities required, TEM is still only available in certain facilities.

Picture loading failed. Figure 5. Transmission Electron Microscopy of hantavirus virions[52]

Summary

Infectious diseases are a real public health threat, outbreaks can have serious social, political, and economic effects. A complex number of factors relating to human behavior and activities, pathogen evolution, poverty, and changes in the environment as well as dynamic human interactions with animals have been found to contribute to infectious disease emergence and transmission. Aggressive research is warranted to unravel important characteristics of pathogens necessary for diagnostics, therapeutics, and vaccine development. Here we describe some strategies for the diagnosis of human infectious diseases, hoping to be helpful for clinical diagnosis and epidemic prevention and control of infectious diseases. To date, multiple Diagnostics techniques have been developed. Various Diagnostics tools show both significances and limitations. Conventional approaches to quantify infective viral particles are labor-intensive, time-consuming, and often associated with poor reproducibility. Immunological tests generally provide quick results, however, is quite expensive due to the requirement of antigen-specific antibody. While RT-PCR may be able to provide results within a matter of hours, it is laborious, requires a skilled operator, and is sensitive to contamination. TEM-based quantification, although highly accurate in determining the shape and the total number of viral particles, often considered time-consuming, extremely expensive and impractical for high sample numbers. Moreover, TEM sample preparation is tedious, and the technique requires sophisticated instrument and a skilled operator. To alleviate these limitations, there is still a need to develop new cost-effective analytical methods that can allow users to quickly and easily determine virus concentrations and reduce constrictions coupled with current assays. Nevertheless, any such emerging methods must be carefully evaluated in terms of their efficiency, precision and linear range. The evaluation of each Diagnostics technique and approval from the FDA are necessary before practical application.

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[46] Johnson K, Lange J, Webb P, Murphy F. Isolation and partial characterisation of a new virus causing acute haemorrhagic fever in Zaire. Lancet. 1977; 1:569-71
[47] Pattyn S, van der Groen G, Jacob W, Piot P, Courteille G. Isolation of Marburg-like virus from a case of haemorrhagic fever in Zaire. Lancet. 1977; 1:573-4
[48] Chua K, Wong E, Cropp B, Hyatt A. Role of electron microscopy in Nipah virus outbreak investigation and control. Med J Malaysia. 2007; 62:139-42
[49] Hyatt A, Zaki S, Goldsmith C, Wise T, Hengstberger S. Ultrastructure of Hendra virus and Nipah virus within cultured cells and host animals. Microbes Infect. 2001; 3:297-306
[50] Drosten C, Gunther S, Preiser W, van der Werf S, Brodt H, Becker S, et al. Identification of a novel coronavirus in patients with severe acute respiratory syndrome. N Engl J Med. 2003; 348:1967-76
[51] Reed K, Melski J, Graham M, Regnery R, Sotir M, Wegner M, et al. The detection of monkeypox in humans in the Western Hemisphere. N Engl J Med. 2004; 350:342-50
[52] https://www.hantasite.com/2017/03/hantavirus-life-cycle-and-infection.html

Diagnostics antibodies and antigens for infectious disease detection


It is important to diagnose the infectious disease even before it becomes serious. The traditional pathogen-detection methods, such as culture, have established their credibility over time, they are often slow and relatively insensitive. In addition, there are several emerging infectious diseases (ID) such as dengue fever, zika virus, corona virus and so on are need to be diagnosed immediately to prevent the outbreak. Immunodiagnostics show great promise than the traditional methods used in clinical diagnosis. GENEMEDI developed the antigens and antibodies for rapid kit such as ELISA, Lateral flow immunoassay (LFIA), colloidal gold immunochromatographic assay, Chemiluminescent immunoassay (CLIA), turbidimetric inhibition immuno assay (TINIA), immunonephelometry and POCT to detect the different types of infectious disease.

Classification: Flu A Flu B HIV-1 HIV-2 HIV1/2 HIV-O HCV Treponema Pallidum T. gondii rubella virus Cytomegalovirus HSV HSV-1 HSV-2 B. anthracis Ebola virus Vaccinia virus (cowpox virus) West Nile virus Adenovirus Plasmodium Astrovirus Norovirus C. jejuni L. monocytogenes Rotavirus Salmonella typhi C. albicans HPV HBV HBV-PreS1 Food source pathogenic bacteria resistant Rift Valley Fever EBV V. cholerae M. tuberculosis Cryptosporidium parvum (Cp23 ) RSV Rhinoviruses dengue nonstructural 1 (DEN-NS1) Enterovirus streptolysin O Mycoplasma pneumoniae Helicobacter pylori Prion STDs ARTI SARS-CoV2 Ribavirin(RBV) Amantadine(AM)



Influenza A (flu A)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P001-Tg001 Influenza A (flu A) nucleoprotein (NP) Flu GMP-IVD-P001-Tg001-Ag01:
Recombinant Influenza A (flu A) nucleoprotein (NP) Protein		 Influenza A (nucleoprotein (NP)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in nucleoprotein (NP) level test of Infectious disease (Flu) and related syndrome evaluation. GMP-IVD-P001-Tg001-Ab01;
GMP-IVD-P001-Tg001-Ab02:
Anti-Influenza A (flu A) nucleoprotein (NP) mouse monoclonal antibody (mAb)		 Influenza A (nucleoprotein (NP)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Influenza A (nucleoprotein (NP)) antibodies in nucleoprotein (NP) level test of Infectious disease (Flu) and related syndrome evaluation. Picture loading failed.

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Influenza B (Flu B)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P002-Tg001 Influenza B (Flu B) nucleoprotein (NP) Flu GMP-IVD-P002-Tg001-Ag01:
Recombinant Influenza B (Flu B) nucleoprotein (NP) Protein		 Influenza B (nucleoprotein (NP)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in nucleoprotein (NP) level test of Infectious disease (Flu) and related syndrome evaluation. GMP-IVD-P002-Tg001-Ab01;
GMP-IVD-P002-Tg001-Ab02:
Anti-Influenza B (Flu B) nucleoprotein (NP) mouse monoclonal antibody (mAb)		 Influenza B (nucleoprotein (NP)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Influenza B (nucleoprotein (NP)) antibodies in nucleoprotein (NP) level test of Infectious disease (Flu) and related syndrome evaluation. Picture loading failed.

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Human immunodeficiency virus 1 (HIV-1)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P003-Tg001 Human immunodeficiency virus 1 (HIV-1) GP41 Protein Acquired immunodeficiency syndrome(AIDS) GMP-IVD-P003-Tg001-Ag01:
Recombinant Human immunodeficiency virus 1 (HIV-1) GP41 Protein Protein		 Human immunodeficiency virus 1 (GP41 Protein) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in GP41 Protein level test of Infectious disease (Acquired immunodeficiency syndrome(AIDS)) and related syndrome evaluation. GMP-IVD-P003-Tg001-Ab01;
GMP-IVD-P003-Tg001-Ab02:
Anti-Human immunodeficiency virus 1 (HIV-1) GP41 Protein mouse monoclonal antibody (mAb) 		Human immunodeficiency virus 1 (GP41 Protein) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Human immunodeficiency virus 1 (GP41 Protein) antibodies in GP41 Protein level test of Infectious disease (Acquired immunodeficiency syndrome(AIDS)) and related syndrome evaluation. Picture loading failed.

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Human immunodeficiency virus 2 (HIV-2)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P004-Tg001 Human immunodeficiency virus 2 (HIV-2) GP36 Protein Acquired immunodeficiency syndrome(AIDS) GMP-IVD-P004-Tg001-Ag01:
Recombinant Human immunodeficiency virus 2 (HIV-2) GP36 Protein Protein		 Human immunodeficiency virus 2 (GP36 Protein) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in GP36 Protein level test of Infectious disease (Acquired immunodeficiency syndrome(AIDS)) and related syndrome evaluation. GMP-IVD-P004-Tg001-Ab01;
GMP-IVD-P004-Tg001-Ab02:
Anti-Human immunodeficiency virus 2 (HIV-2) GP36 Protein mouse monoclonal antibody (mAb) 		Human immunodeficiency virus 2 (GP36 Protein) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Human immunodeficiency virus 2 (GP36 Protein) antibodies in GP36 Protein level test of Infectious disease (Acquired immunodeficiency syndrome(AIDS)) and related syndrome evaluation. Picture loading failed.

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immunodeficiency virus 1/2 (HIV1/2)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P005-Tg001 immunodeficiency virus 1/2 (HIV1/2) HIV p24 antigen AIDS GMP-IVD-P005-Tg001-Ag01:
Recombinant immunodeficiency virus 1/2 (HIV1/2) HIV p24 antigen Protein		 immunodeficiency virus 1/2 (HIV p24 antigen) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in HIV p24 antigen level test of Infectious disease (AIDS) and related syndrome evaluation. GMP-IVD-P005-Tg001-Ab01;
GMP-IVD-P005-Tg001-Ab02:
Anti-immunodeficiency virus 1/2 (HIV1/2) HIV p24 antigen mouse monoclonal antibody (mAb)		 immunodeficiency virus 1/2 (HIV p24 antigen) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other immunodeficiency virus 1/2 (HIV p24 antigen) antibodies in HIV p24 antigen level test of Infectious disease (AIDS) and related syndrome evaluation. Picture loading failed.

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immunodeficiency virus-O antigen (HIV-O)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P006-Tg001 immunodeficiency virus-O antigen (HIV-O) O-antigen AIDS GMP-IVD-P006-Tg001-Ag01:
Recombinant immunodeficiency virus-O antigen (HIV-O) O-antigen Protein		 immunodeficiency virus-O antigen (O-antigen) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in O-antigen level test of Infectious disease (AIDS) and related syndrome evaluation. GMP-IVD-P006-Tg001-Ab01;
GMP-IVD-P006-Tg001-Ab02:
Anti-immunodeficiency virus-O antigen (HIV-O) O-antigen mouse monoclonal antibody (mAb)		 immunodeficiency virus-O antigen (O-antigen) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other immunodeficiency virus-O antigen (O-antigen) antibodies in O-antigen level test of Infectious disease (AIDS) and related syndrome evaluation. Picture loading failed.

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hepatitis C virus (HCV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P007-Tg001 hepatitis C virus (HCV) Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) Hepatitis C GMP-IVD-P007-Tg001-Ag01:
Recombinant hepatitis C virus (HCV) Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) Protein		 HCV core antigen (Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) level test of Infectious disease (Hepatitis C) and related syndrome evaluation. GMP-IVD-P007-Tg001-Ab01;
GMP-IVD-P007-Tg001-Ab02:
Anti-hepatitis C virus (HCV) Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) mouse monoclonal antibody (mAb)		 HCV core antigen (Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other HCV core antigen (Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag)) antibodies in Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) level test of Infectious disease (Hepatitis C) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P007-Tg002 hepatitis C virus (HCV) HCV core antigen Hepatitis C GMP-IVD-P007-Tg002-Ag01:
Recombinant hepatitis C virus (HCV) core protein		 Hepatitis C virus core protein (HCV core protein) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in core protein level test of Infectious disease (Hepatitis C) and related syndrome evaluation GMP-IVD-P007-Tg002-Ab01;
GMP-IVD-P007-Tg002-Ab02:
Anti-hepatitis C virus (HCV) core protein mouse monoclonal antibody (mAb)		 Hepatitis C virus core antigen (HCV core antigen) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Hepatitis C virus core antigen (HCV core antigen) antibodies in HCV core antigen level test of Infectious disease (Hepatitis C) and related syndrome evaluation. Picture loading failed.

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Treponema Pallidum (TP)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P008-Tg001 Treponema Pallidum (TP) Recombinant TP P15-P17-P47 fusion Protein (His Tag) syphilis GMP-IVD-P008-Tg001-Ag01:
Recombinant Treponema Pallidum (TP) Recombinant TP P15-P17-P47 fusion Protein (His Tag) Protein		 Treponema Pallidum (Recombinant TP P15-P17-P47 fusion Protein (His Tag)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in Recombinant TP P15-P17-P47 fusion Protein (His Tag) level test of Infectious disease (syphilis) and related syndrome evaluation. GMP-IVD-P008-Tg001-Ab01;
GMP-IVD-P008-Tg001-Ab02:
Anti-Treponema Pallidum (TP) Recombinant TP P15-P17-P47 fusion Protein (His Tag) mouse monoclonal antibody (mAb)		 Treponema Pallidum (Recombinant TP P15-P17-P47 fusion Protein (His Tag)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Treponema Pallidum (Recombinant TP P15-P17-P47 fusion Protein (His Tag)) antibodies in Recombinant TP P15-P17-P47 fusion Protein (His Tag) level test of Infectious disease (syphilis) and related syndrome evaluation. Picture loading failed.

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Toxoplasma gondii (T. gondii)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P009-Tg001 Toxoplasma gondii (T. gondii) P30 Toxoplasmosis GMP-IVD-P009-Tg001-Ag01:
Recombinant Toxoplasma gondii (T. gondii) P30 Protein		 toxoplasma gondii (P30) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in P30 level test of Infectious disease (Toxoplasmosis) and related syndrome evaluation. GMP-IVD-P009-Tg001-Ab01;
GMP-IVD-P009-Tg001-Ab02:
Anti-Toxoplasma gondii (T. gondii) P30 mouse monoclonal antibody (mAb)		 toxoplasma gondii (P30) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other toxoplasma gondii (P30) antibodies in P30 level test of Infectious disease (Toxoplasmosis) and related syndrome evaluation. Picture loading failed.

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rubella virus

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P010-Tg001 rubella virus CAPSID (C) Rubella or German measles or three-day measlesis GMP-IVD-P010-Tg001-Ag01:
Recombinant rubella virus CAPSID (C) Protein		 rubella virus (CAPSID (C)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in CAPSID (C) level test of Infectious disease (Rubella or German measles or three-day measlesis) and related syndrome evaluation. GMP-IVD-P010-Tg001-Ab01;
GMP-IVD-P010-Tg001-Ab02:
Anti-rubella virus CAPSID (C) mouse monoclonal antibody (mAb)		 rubella virus (CAPSID (C)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other rubella virus (CAPSID (C)) antibodies in CAPSID (C) level test of Infectious disease (Rubella or German measles or three-day measlesis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P010-Tg002 rubella virus Nucleoprotein Rubella GMP-IVD-P010-Tg002-Ag01:
Recombinant rubella virus Nucleoprotein Protein		 rubella virus (Nucleoprotein) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in Nucleoprotein level test of Infectious disease (Rubella) and related syndrome evaluation. GMP-IVD-P010-Tg002-Ab01;
GMP-IVD-P010-Tg002-Ab02:
Anti-rubella virus Nucleoprotein mouse monoclonal antibody (mAb)		 rubella virus (Nucleoprotein) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other rubella virus (Nucleoprotein) antibodies in Nucleoprotein level test of Infectious disease (Rubella) and related syndrome evaluation. Picture loading failed.

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Cytomegalovirus (CMV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P011-Tg001 Cytomegalovirus (CMV) pp65 chickenpox, herpes simplex and mononucleosis GMP-IVD-P011-Tg001-Ag01:
Recombinant Cytomegalovirus (CMV) pp65 Protein		 Cytomegalovirus (pp65) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in pp65 level test of Infectious disease (chickenpox, herpes simplex and mononucleosis) and related syndrome evaluation. GMP-IVD-P011-Tg001-Ab01;
GMP-IVD-P011-Tg001-Ab02:
Anti-Cytomegalovirus (CMV) pp65 mouse monoclonal antibody (mAb)		 Cytomegalovirus (pp65) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Cytomegalovirus (pp65) antibodies in pp65 level test of Infectious disease (chickenpox, herpes simplex and mononucleosis) and related syndrome evaluation. Picture loading failed.

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herpes simplex virus (HSV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P012-Tg001 herpes simplex virus (HSV) glycoprotein G HSV-1 and HSV-2, can cause oral or genital infection. Most often, HSV-1 causes gingivostomatitis, herpes labialis, and herpes keratitis. HSV-2 usually causes genital lesions. Generally, recurrent eruptions are less severe and occur less frequently over time. GMP-IVD-P012-Tg001-Ag01:
Recombinant herpes simplex virus (HSV) Protein		 herpes simplex virus antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in herpes simplex virus level test of Infectious disease (HSV-1 and HSV-2, can cause oral or genital infection. Most often, HSV-1 causes gingivostomatitis, herpes labialis, and herpes keratitis. HSV-2 usually causes genital lesions. Generally, recurrent eruptions are less severe and occur less frequently over time.) and related syndrome evaluation. GMP-IVD-P012-Tg001-Ab01;
GMP-IVD-P012-Tg001-Ab02:
Anti-herpes simplex virus (HSV) mouse monoclonal antibody (mAb)		 herpes simplex virus antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other herpes simplex virus antibodies in herpes simplex virus level test of Infectious disease (HSV-1 and HSV-2, can cause oral or genital infection. Most often, HSV-1 causes gingivostomatitis, herpes labialis, and herpes keratitis. HSV-2 usually causes genital lesions. Generally, recurrent eruptions are less severe and occur less frequently over time.) and related syndrome evaluation. Picture loading failed.

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Herpes simplex virus 1 (HSV-1)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P013-Tg001 Herpes simplex virus 1 (HSV-1) glycoprotein G (gG-1) oral herpes GMP-IVD-P013-Tg001-Ag01:
Recombinant Herpes simplex virus 1 (HSV-1) glycoprotein G (gG-1) Protein		 Herpes simplex virus 1 (glycoprotein G (gG-1)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in glycoprotein G (gG-1) level test of Infectious disease (oral herpes) and related syndrome evaluation. GMP-IVD-P013-Tg001-Ab01;
GMP-IVD-P013-Tg001-Ab02:
Anti-Herpes simplex virus 1 (HSV-1) glycoprotein G (gG-1) mouse monoclonal antibody (mAb) 		Herpes simplex virus 1 (glycoprotein G (gG-1)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Herpes simplex virus 1 (glycoprotein G (gG-1)) antibodies in glycoprotein G (gG-1) level test of Infectious disease (oral herpes) and related syndrome evaluation. Picture loading failed.

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Herpes simplex virus 2 (HSV-2)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P014-Tg001 Herpes simplex virus 2 (HSV-2) glycoprotein G (gG-2) genital herpes GMP-IVD-P014-Tg001-Ag01:
Recombinant Herpes simplex virus 2 (HSV-2) glycoprotein G (gG-2) Protein		 Herpes simplex virus 2 (glycoprotein G (gG-2)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in glycoprotein G (gG-2) level test of Infectious disease (genital herpes) and related syndrome evaluation. GMP-IVD-P014-Tg001-Ab01;
GMP-IVD-P014-Tg001-Ab02:
Anti-Herpes simplex virus 2 (HSV-2) glycoprotein G (gG-2) mouse monoclonal antibody (mAb) 		Herpes simplex virus 2 (glycoprotein G (gG-2)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Herpes simplex virus 2 (glycoprotein G (gG-2)) antibodies in glycoprotein G (gG-2) level test of Infectious disease (genital herpes) and related syndrome evaluation. Picture loading failed.

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Bacillus anthracis (B. anthracis)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P015-Tg001 Bacillus anthracis (B. anthracis) protective antigen (PA) Anthrax GMP-IVD-P015-Tg001-Ag01:
Recombinant Bacillus anthracis (B. anthracis) protective antigen (PA) Protein		 anthrax bacillus (protective antigen (PA)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in protective antigen (PA) level test of Infectious disease (Anthrax) and related syndrome evaluation. GMP-IVD-P015-Tg001-Ab01;
GMP-IVD-P015-Tg001-Ab02:
Anti-Bacillus anthracis (B. anthracis) protective antigen (PA) mouse monoclonal antibody (mAb) 		anthrax bacillus (protective antigen (PA)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other anthrax bacillus (protective antigen (PA)) antibodies in protective antigen (PA) level test of Infectious disease (Anthrax) and related syndrome evaluation. Picture loading failed.

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Ebola virus (EV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P016-Tg001 ebola virus (EV) nucleoprotein (NP) Ebola Virus Disease GMP-IVD-P016-Tg001-Ag01:
Recombinant ebola virus (EV) nucleoprotein (NP) Protein		 ebola virus (nucleoprotein (NP)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in nucleoprotein (NP) level test of Infectious disease (Ebola Virus Disease) and related syndrome evaluation. GMP-IVD-P016-Tg001-Ab01;
GMP-IVD-P016-Tg001-Ab02:
Anti-ebola virus (EV) nucleoprotein (NP) mouse monoclonal antibody (mAb)		 ebola virus (nucleoprotein (NP)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other ebola virus (nucleoprotein (NP)) antibodies in nucleoprotein (NP) level test of Infectious disease (Ebola Virus Disease) and related syndrome evaluation. Picture loading failed.

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Vaccinia virus (cowpox virus)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P017-Tg001 Vaccinia virus (cowpox virus) A27L Cowpox GMP-IVD-P017-Tg001-Ag01:
Recombinant Vaccinia virus (cowpox virus) A27L Protein		 Vaccinia virus (cowpox virus) A27L antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in A27L level test of Infectious disease (Cowpox) and related syndrome evaluation. GMP-IVD-P017-Tg001-Ab01;
GMP-IVD-P017-Tg001-Ab02:
Anti-Vaccinia virus (cowpox virus) A27L mouse monoclonal antibody (mAb)		 Vaccinia virus (cowpox virus) A27L antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Vaccinia virus (cowpox virus) A27L antibodies in A27L level test of Infectious disease (Cowpox) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P017-Tg002 Vaccinia virus (cowpox virus) h3l Cowpox GMP-IVD-P017-Tg002-Ag01:
Recombinant Vaccinia virus (cowpox virus) h3l Protein		 Vaccinia virus (cowpox virus) h3l antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in h3l level test of Infectious disease (Cowpox) and related syndrome evaluation. GMP-IVD-P017-Tg002-Ab01;
GMP-IVD-P017-Tg002-Ab02:
Anti-Vaccinia virus (cowpox virus) h3l mouse monoclonal antibody (mAb)		 Vaccinia virus (cowpox virus) h3l antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Vaccinia virus (cowpox virus) h3l antibodies in h3l level test of Infectious disease (Cowpox) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P017-Tg003 Vaccinia virus (cowpox virus) b5r Cowpox GMP-IVD-P017-Tg003-Ag01:
Recombinant Vaccinia virus (cowpox virus) b5r Protein		 Vaccinia virus (cowpox virus) b5r antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in b5r level test of Infectious disease (Cowpox) and related syndrome evaluation. GMP-IVD-P017-Tg003-Ab01;
GMP-IVD-P017-Tg003-Ab02:
Anti-Vaccinia virus (cowpox virus) b5r mouse monoclonal antibody (mAb)		 Vaccinia virus (cowpox virus) b5r antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Vaccinia virus (cowpox virus) b5r antibodies in b5r level test of Infectious disease (Cowpox) and related syndrome evaluation. Picture loading failed.

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West Nile virus (WNV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P018-Tg001 West Nile virus (WNV) envelope (E) West Nile fever GMP-IVD-P018-Tg001-Ag01:
Recombinant West Nile virus (WNV) envelope (E) Protein		 West Nile virus (envelope (E)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in envelope (E) level test of Infectious disease (West Nile fever) and related syndrome evaluation. GMP-IVD-P018-Tg001-Ab01;
GMP-IVD-P018-Tg001-Ab02:
Anti-West Nile virus (WNV) envelope (E) mouse monoclonal antibody (mAb)		 West Nile virus (envelope (E)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other West Nile virus (envelope (E)) antibodies in envelope (E) level test of Infectious disease (West Nile fever) and related syndrome evaluation. Picture loading failed.

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Adenovirus

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P019-Tg001 adenovirus Hexon cold-like symptoms, fever, sore throat, bronchitis, pneumonia, diarrhea, and pink eye (conjunctivitis) GMP-IVD-P019-Tg001-Ag01:
Recombinant adenovirus Hexon Protein		 adenovirus (Hexon) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in Hexon level test of Infectious disease (cold-like symptoms, fever, sore throat, bronchitis, pneumonia, diarrhea, and pink eye (conjunctivitis)) and related syndrome evaluation. GMP-IVD-P019-Tg001-Ab01;
GMP-IVD-P019-Tg001-Ab02:
Anti-adenovirus (Hexon) mouse monoclonal antibody (mAb)		 adenovirus Hexon antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other (Hexon) antibodies in Hexon level test of Infectious disease (cold-like symptoms, fever, sore throat, bronchitis, pneumonia, diarrhea, and pink eye (conjunctivitis)) and related syndrome evaluation. Picture loading failed.

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Plasmodium [Plasmodium falciparum] [Plasmodium knowlesi] [Plasmodium malariae] [Plasmodium ovale] [Plasmodium vivax]

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P020-Tg001 Plasmodium [Plasmodium falciparum] [Plasmodium knowlesi] [Plasmodium malariae] [Plasmodium ovale] [Plasmodium vivax] merozoite surface protein (MSP) malaria GMP-IVD-P020-Tg001-Ag01:
Recombinant Plasmodium merozoite surface protein (MSP) Protein		 Plasmodium (Circumsporozoite Protein (CSP)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in CSP level test of Infectious disease(malaria) and related syndrome evaluation. GMP-IVD-P020-Tg001-Ab01;
GMP-IVD-P020-Tg001-Ab02:
Anti-Plasmodium merozoite surface protein (MSP) mouse monoclonal antibody (mAb)		 Plasmodium malaria (Circumsporozoite Protein (CSP)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Plasmodium (Circumsporozoite Protein (CSP)) antibodies in CSP level test of Infectious disease (malaria) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P020-Tg002 Plasmodium [Plasmodium falciparum] [Plasmodium knowlesi] [Plasmodium malariae] [Plasmodium ovale] [Plasmodium vivax] Circumsporozoite Protein (CSP) malaria GMP-IVD-P020-Tg002-Ag01:
Recombinant Plasmodium Circumsporozoite Protein (CSP) Protein		 malaria (Circumsporozoite Protein (CSP)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in MSP level test of Infectious disease (malaria) and related syndrome evaluation. GMP-IVD-P020-Tg002-Ab01;
GMP-IVD-P020-Tg002-Ab02:
Anti-Plasmodium Circumsporozoite Protein (CSP) mouse monoclonal antibody (mAb)		 malaria (Circumsporozoite Protein (CSP)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other malaria (Circumsporozoite Protein (CSP)) antibodies in MSP level test of Infectious disease (malaria) and related syndrome evaluation. Picture loading failed.

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Astrovirus

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P021-Tg001 Astrovirus capsid proteins gastroenteritis GMP-IVD-P021-Tg001-Ag01:
Recombinant Astrovirus capsid proteins Protein		 Astrovirus (capsid proteins) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in capsid proteins level test of Infectious disease (gastroenteritis) and related syndrome evaluation. GMP-IVD-P021-Tg001-Ab01;
GMP-IVD-P021-Tg001-Ab02:
Anti-Astrovirus capsid proteins mouse monoclonal antibody (mAb)		 Astrovirus (capsid proteins) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Astrovirus (capsid proteins) antibodies in capsid proteins level test of Infectious disease (gastroenteritis) and related syndrome evaluation. Picture loading failed.

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Norovirus (NV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P022-Tg001 Norovirus (NV) VP1 vomiting and diarrhea GMP-IVD-P022-Tg001-Ag01:
Recombinant Norovirus (NV) VP1 Protein		 Norovirus (VP1) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in VP1 level test of Infectious disease (vomiting and diarrhea) and related syndrome evaluation. GMP-IVD-P022-Tg001-Ab01;
GMP-IVD-P022-Tg001-Ab02:
Anti-Norovirus (NV) VP1 mouse monoclonal antibody (mAb)		 Norovirus (VP1) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Norovirus (VP1) antibodies in VP1 level test of Infectious disease (vomiting and diarrhea) and related syndrome evaluation. Picture loading failed.

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Campylobacter jejuni (C. jejuni)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P023-Tg001 Campylobacter jejuni (C. jejuni) Outer Membrane Protein (OMP) gastroenteritis GMP-IVD-P023-Tg001-Ag01:
Recombinant Campylobacter jejuni (C. jejuni) Outer Membrane Protein (OMP)		 Campylobacter jejuni (Outer Membrane Protein (OMP)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in Outer Membrane Protein (OMP) level test of Infectious disease (gastroenteritis) and related syndrome evaluation. GMP-IVD-P023-Tg001-Ab01;
GMP-IVD-P023-Tg001-Ab02:
Anti-Campylobacter jejuni (C. jejuni) Outer Membrane Protein (OMP) mouse monoclonal antibody (mAb) 		Campylobacter jejuni (Outer Membrane Protein (OMP)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Campylobacter jejuni (Outer Membrane Protein (OMP)) antibodies in Outer Membrane Protein (OMP) level test of Infectious disease (gastroenteritis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P023-Tg002 Campylobacter jejuni (C. jejuni) Flagellar L-ring protein (FLGH) gastroenteritis GMP-IVD-P023-Tg002-Ag01:
Recombinant Campylobacter jejuni (C. jejuni) Flagellar L-ring protein (FLGH) Protein		 Campylobacter jejuni (Flagellar L-ring protein (FLGH)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in Flagellar L-ring protein (FLGH) level test of Infectious disease (gastroenteritis) and related syndrome evaluation. GMP-IVD-P023-Tg002-Ab01;
GMP-IVD-P023-Tg002-Ab02:
Anti-Campylobacter jejuni (C. jejuni) Flagellar L-ring protein (FLGH) mouse monoclonal antibody (mAb)		 Campylobacter jejuni (Flagellar L-ring protein (FLGH)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Campylobacter jejuni (Flagellar L-ring protein (FLGH)) antibodies in Flagellar L-ring protein (FLGH) level test of Infectious disease (gastroenteritis) and related syndrome evaluation. Picture loading failed.

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Listeria monocytogenes (L. monocytogenes)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P024-Tg001 Listeria monocytogenes (L. monocytogenes) Listeriolysin O (LLO) Listeriosis GMP-IVD-P024-Tg001-Ag01:
Recombinant Listeria monocytogenes (L. monocytogenes) Listeriolysin O (LLO) Protein		 Listeria monocytogenes (Listeriolysin O (LLO)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in Listeriolysin O (LLO) level test of Infectious disease (Listeriosis) and related syndrome evaluation. GMP-IVD-P024-Tg001-Ab01;
GMP-IVD-P024-Tg001-Ab02:
Anti-Listeria monocytogenes (L. monocytogenes) Listeriolysin O (LLO) mouse monoclonal antibody (mAb)		 Listeria monocytogenes (Listeriolysin O (LLO)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Listeria monocytogenes (Listeriolysin O (LLO)) antibodies in Listeriolysin O (LLO) level test of Infectious disease (Listeriosis) and related syndrome evaluation. Picture loading failed.

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Rotavirus

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P025-Tg001 rotavirus VP6 watery diarrhea and vomiting GMP-IVD-P025-Tg001-Ag01:
Recombinant rotavirus VP6 Protein		 rotavirus (VP6) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in VP6 level test of Infectious disease (watery diarrhea and vomiting) and related syndrome evaluation. GMP-IVD-P025-Tg001-Ab01;
GMP-IVD-P025-Tg001-Ab02:
Anti-rotavirus VP6 mouse monoclonal antibody (mAb)		 rotavirus (VP6) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other rotavirus (VP6) antibodies in VP6 level test of Infectious disease (watery diarrhea and vomiting) and related syndrome evaluation. Picture loading failed.

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Salmonella typhi

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P026-Tg001 Salmonella typhi outer membrane channel protein (Tolc) OMP 50 (Salmonella typhi) Salmonellosis GMP-IVD-P026-Tg001-Ag01:
Recombinant Salmonella typhi outer membrane channel protein (Tolc) OMP 50 (Salmonella typhi) Protein		 salmonella (outer membrane channel protein (Tolc) OMP 50 (Salmonella typhi)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in outer membrane channel protein (Tolc) OMP 50 (Salmonella typhi) level test of Infectious disease (Salmonellosis) and related syndrome evaluation. GMP-IVD-P026-Tg001-Ab01;
GMP-IVD-P026-Tg001-Ab02:
Anti-Salmonella typhi outer membrane channel protein (Tolc) OMP 50 (Salmonella typhi) mouse monoclonal antibody (mAb)		 salmonella (outer membrane channel protein (Tolc) OMP 50 (Salmonella typhi)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other salmonella (outer membrane channel protein (Tolc) OMP 50 (Salmonella typhi)) antibodies in outer membrane channel protein (Tolc) OMP 50 (Salmonella typhi) level test of Infectious disease (Salmonellosis) and related syndrome evaluation. Picture loading failed.

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Candida albicans (C. albicans)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P027-Tg001 Candida albicans (C. albicans) enolase (Candida albicans) Candidiasis GMP-IVD-P027-Tg001-Ag01:
Recombinant Candida albicans (C. albicans) enolase (Candida albicans) Protein		 candida (enolase (Candida albicans)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in enolase (Candida albicans) level test of Infectious disease (Candidiasis) and related syndrome evaluation. GMP-IVD-P027-Tg001-Ab01;
GMP-IVD-P027-Tg001-Ab02:
Anti-Candida albicans (C. albicans) enolase (Candida albicans) mouse monoclonal antibody (mAb)		 candida (enolase (Candida albicans)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other candida (enolase (Candida albicans)) antibodies in enolase (Candida albicans) level test of Infectious disease (Candidiasis) and related syndrome evaluation. Picture loading failed.

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Human papilloma virus (HPV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P028-Tg001 Human papilloma virus (HPV) HPV 16 L1 capsid protein cervical and other cancers GMP-IVD-P028-Tg001-Ag01:
Recombinant Human papilloma virus (HPV) HPV 16 L1 capsid protein Protein		 papilloma virus (HPV 16 L1 capsid protein) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in HPV 16 L1 capsid protein level test of Infectious disease (cervical and other cancers) and related syndrome evaluation. GMP-IVD-P028-Tg001-Ab01;
GMP-IVD-P028-Tg001-Ab02:
Anti-Human papilloma virus (HPV) HPV 16 L1 capsid protein mouse monoclonal antibody (mAb) 		papilloma virus (HPV 16 L1 capsid protein) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other papilloma virus (HPV 16 L1 capsid protein) antibodies in HPV 16 L1 capsid protein level test of Infectious disease (cervical and other cancers) and related syndrome evaluation. Picture loading failed.

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Hepatitis b virus (HBV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P029-Tg001 Hepatitis b virus (HBV) HBsAg (hepatitis B surface antigen) Hepatitis B GMP-IVD-P029-Tg001-Ag01:
Recombinant Hepatitis b virus (HBV) HBsAg Protein		 Hepatitis B s antigen (HBsAg) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in HBsAg level test of Infectious disease (Hepatitis B) and related syndrome evaluation. GMP-IVD-P029-Tg001-Ab01;
GMP-IVD-P029-Tg001-Ab02:
Anti-Hepatitis B virus (HBV) HBsAg mouse monoclonal antibody (mAb)		 Hepatitis B s antigen (HBsAg) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Hepatitis B s antigen (HBsAg) antibodies in HBsAg level test of Infectious disease (Hepatitis B) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P029-Tg002 Hepatitis B virus (HBV) HBeAg (hepatitis B e-antigen) Hepatitis B GMP-IVD-P029-Tg002-Ag01:
Recombinant Hepatitis B virus (HBV) HBeAg Protein		 Hepatitis B e antigen (HBeAg) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in HBeAg level test of Infectious disease (Hepatitis B) and related syndrome evaluation. GMP-IVD-P029-Tg002-Ab01;
GMP-IVD-P029-Tg002-Ab02:
Anti-Hepatitis B virus (HBV) HBeAg mouse monoclonal antibody (mAb)		 Hepatitis B e antigen (HBeAg) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other hepatitis B e antigen (HBeAg) antibodies in HBeAg level test of Infectious disease (Hepatitis B) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P029-Tg003 Hepatitis B virus (HBV) HBcAg (hepatitis B Core antigen) Hepatitis B GMP-IVD-P029-Tg003-Ag01:
Recombinant Hepatitis B virus (HBV) HBcAg Protein		 Hepatitis B core antigen (HBcAg) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in HBcAg level test of Infectious disease (Hepatitis B) and related syndrome evaluation. GMP-IVD-P029-Tg003-Ab01;
GMP-IVD-P029-Tg003-Ab02:
Anti-Hepatitis B virus (HBV) HBcAg mouse monoclonal antibody (mAb)		 Hepatitis B core antigen (HBcAg) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other hepatitis B core antigen (HBcAg) antibodies in HBcAg level test of Infectious disease (Hepatitis B) and related syndrome evaluation. Picture loading failed.

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Hepatitis B virus-PreS1 (HBV-PreS1)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P030-Tg001 Hepatitis B virus-PreS1 (HBV-PreS1 ) PreS1 Hepatitis B GMP-IVD-P030-Tg001-Ag01:
Recombinant Hepatitis B virus-PreS1 (HBV-PreS1 ) PreS1 Protein		 Hepatitis B virus-PreS1 (PreS1) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in PreS1 level test of Infectious disease (Hepatitis B) and related syndrome evaluation. GMP-IVD-P030-Tg001-Ab01;
GMP-IVD-P030-Tg001-Ab02:
Anti-Hepatitis B virus-PreS1 (HBV-PreS1 ) PreS1 mouse monoclonal antibody (mAb)		 Hepatitis B virus-PreS1 (PreS1) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Hepatitis B virus-PreS1 (PreS1) antibodies in PreS1 level test of Infectious disease (Hepatitis B) and related syndrome evaluation. Picture loading failed.

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Food source pathogenic bacteria resistant

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P031-Tg001 NA NA Food source pathogenic bacteria resistant GMP-IVD-P031-Tg001-Ag01:
Recombinant Food source pathogenic bacteria resistant Protein		 Food source pathogenic bacteria resistant antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests, and other immunoassays as control material in Food source pathogenic bacteria resistant level test of Infectious disease (Food source pathogenic bacteria resistant) and related syndrome evaluation. GMP-IVD-P031-Tg001-Ab01;
GMP-IVD-P031-Tg001-Ab02:
Anti-Food source pathogenic bacteria resistant mouse monoclonal antibody (mAb)		 Food source pathogenic bacteria resistant antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Food source pathogenic bacteria resistant antibodies in Food source pathogenic bacteria resistant level test of Infectious disease (Food source pathogenic bacteria resistant) and related syndrome evaluation. Picture loading failed.

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Rift Valley Fever (RVF)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P032-Tg001 Rift Valley Fever (RVF) nucleoprotein (NP) Rift Valley Fever GMP-IVD-P032-Tg001-Ag01:
Recombinant Rift Valley Fever (RVF) nucleoprotein (NP) Protein		 Rift Valley Fever (nucleoprotein (NP)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in nucleoprotein (NP) level test of Infectious disease(Rift Valley Fever) and related syndrome evaluation. GMP-IVD-P032-Tg001-Ab01;
GMP-IVD-P032-Tg001-Ab02:
Anti-Rift Valley Fever (RVF) nucleoprotein (NP) mouse monoclonal antibody (mAb)		 Rift Valley Fever (nucleoprotein (NP)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Rift Valley Fever (nucleoprotein (NP)) antibodies in nucleoprotein (NP) level test of Infectious disease (Rift Valley Fever) and related syndrome evaluation. Picture loading failed.

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Epstein-Barr virus (EBV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P033-Tg001 Epstein-Barr virus (EBV) Nuclear Antigen (EBNA1) infectious mononucleosis GMP-IVD-P033-Tg001-Ag01:
Recombinant Epstein-Barr virus (EBV) Nuclear Antigen (EBNA1) Protein		 Epstein-Barr virus (Nuclear Antigen (EBNA1)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in Nuclear Antigen (EBNA1) level test of Infectious disease(infectious mononucleosis) and related syndrome evaluation. GMP-IVD-P033-Tg001-Ab01;
GMP-IVD-P033-Tg001-Ab02:
Anti-Epstein-Barr virus (EBV) Nuclear Antigen (EBNA1) mouse monoclonal antibody (mAb)		 Epstein-Barr virus (Nuclear Antigen (EBNA1)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Epstein-Barr virus (Nuclear Antigen (EBNA1)) antibodies in Nuclear Antigen (EBNA1) level test of Infectious disease (infectious mononucleosis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P033-Tg002 Epstein-Barr virus (EBV) capsid antigen (EB-VCA) infectious mononucleosis GMP-IVD-P033-Tg002-Ag01:
Recombinant Epstein-Barr virus (EBV) capsid antigen (EB-VCA) Protein		 Epstein-Barr virus (capsid antigen (EB-VCA)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in capsid antigen (EB-VCA) level test of Infectious disease(infectious mononucleosis) and related syndrome evaluation. GMP-IVD-P033-Tg002-Ab01;
GMP-IVD-P033-Tg002-Ab02:
Anti-Epstein-Barr virus (EBV) capsid antigen (EB-VCA) mouse monoclonal antibody (mAb)		 Epstein-Barr virus (capsid antigen (EB-VCA)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Epstein-Barr virus (capsid antigen (EB-VCA)) antibodies in capsid antigen (EB-VCA) level test of Infectious disease (infectious mononucleosis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P033-Tg003 Epstein-Barr virus (EBV) glycoprotein 350 (gp350) infectious mononucleosis GMP-IVD-P033-Tg003-Ag01:
Recombinant Epstein-Barr virus (EBV) glycoprotein 350 (gp350) Protein		 Epstein-Barr virus (glycoprotein 350 (gp350)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in glycoprotein 350 (gp350) level test of Infectious disease(infectious mononucleosis) and related syndrome evaluation. GMP-IVD-P033-Tg003-Ab01;
GMP-IVD-P033-Tg003-Ab02:
Anti-Epstein-Barr virus (EBV) glycoprotein 350 (gp350) mouse monoclonal antibody (mAb)		 Epstein-Barr virus (glycoprotein 350 (gp350)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Epstein-Barr virus (glycoprotein 350 (gp350)) antibodies in glycoprotein 350 (gp350) level test of Infectious disease (infectious mononucleosis) and related syndrome evaluation. Picture loading failed.

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Vibrio cholerae (V. cholerae)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P035-Tg001 Vibrio cholerae (V. cholerae) cytotoxin B (CtxB) Cholera GMP-IVD-P035-Tg001-Ag01:
Recombinant Vibrio cholerae (V. cholerae) cytotoxin B (CtxB) Protein		 Vibrio cholerae (cytotoxin B (CtxB)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in cytotoxin B (CtxB) level test of Infectious disease(Cholera) and related syndrome evaluation. GMP-IVD-P035-Tg001-Ab01;
GMP-IVD-P035-Tg001-Ab02:
Anti-Vibrio cholerae (V. cholerae) cytotoxin B (CtxB) mouse monoclonal antibody (mAb)		 Vibrio cholerae (cytotoxin B (CtxB)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Vibrio cholerae (cytotoxin B (CtxB)) antibodies in cytotoxin B (CtxB) level test of Infectious disease (Cholera) and related syndrome evaluation. Picture loading failed.

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Mycobacterium tuberculosis (M. tuberculosis)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P036-Tg001 Mycobacterium tuberculosis (M. tuberculosis) M. tb Tuberculosis (TB) GMP-IVD-P036-Tg001-Ag01:
Recombinant Mycobacterium tuberculosis (M. tuberculosis) M. tb Protein		 Mycobacterium tuberculosis (M. tb) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in M. tb level test of Infectious disease(Tuberculosis (TB)) and related syndrome evaluation. GMP-IVD-P036-Tg001-Ab01;
GMP-IVD-P036-Tg001-Ab02:
Anti-Mycobacterium tuberculosis (M. tuberculosis) M. tb mouse monoclonal antibody (mAb)		 Mycobacterium tuberculosis (M. tb) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Mycobacterium tuberculosis (M. tb) antibodies in M. tb level test of Infectious disease (Tuberculosis (TB)) and related syndrome evaluation. Picture loading failed.

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Cryptosporidium parvum (Cp23 )

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P037-Tg001 Cryptosporidium parvum (Cp23 ) Crypto cryptosporidiosis GMP-IVD-P037-Tg001-Ag01:
Recombinant Cryptosporidium parvum (Cp23 ) Crypto Protein		 Cryptosporidium (Crypto) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in Crypto level test of Infectious disease(cryptosporidiosis) and related syndrome evaluation. GMP-IVD-P037-Tg001-Ab01;
GMP-IVD-P037-Tg001-Ab02:
Anti-Cryptosporidium parvum (Cp23 ) Crypto mouse monoclonal antibody (mAb)		 Cryptosporidium (Crypto) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Cryptosporidium (Crypto) antibodies in Crypto level test of Infectious disease (cryptosporidiosis) and related syndrome evaluation. Picture loading failed.

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Respiratory syncytial virus (RSV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P038-Tg001 Respiratory syncytial virus (RSV) major surface glycoproteins (G and F) cold GMP-IVD-P038-Tg001-Ag01:
Recombinant Respiratory syncytial virus (RSV) major surface glycoproteins (G and F) Protein 		Respiratory syncytial virus (major surface glycoproteins (G and F)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in major surface glycoproteins (G and F) level test of Infectious disease(cold) and related syndrome evaluation. GMP-IVD-P038-Tg001-Ab01;
GMP-IVD-P038-Tg001-Ab02:
Anti-Respiratory syncytial virus (RSV) major surface glycoproteins (G and F) mouse monoclonal antibody (mAb)		 Respiratory syncytial virus (major surface glycoproteins (G and F)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Respiratory syncytial virus (major surface glycoproteins (G and F)) antibodies in major surface glycoproteins (G and F) level test of Infectious disease (cold) and related syndrome evaluation. Picture loading failed.

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Rhinoviruses (RV)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P039-Tg001 Rhinoviruses (RV) VP1 common cold GMP-IVD-P039-Tg001-Ag01:
Recombinant Rhinoviruses (RV) VP1 Protein		 Rhinoviruses (VP1) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in VP1 level test of Infectious disease(common cold) and related syndrome evaluation. GMP-IVD-P039-Tg001-Ab01;
GMP-IVD-P039-Tg001-Ab02:
Anti-Rhinoviruses (RV) VP1 mouse monoclonal antibody (mAb)		 Rhinoviruses (VP1) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Rhinoviruses (VP1) antibodies in VP1 level test of Infectious disease (common cold) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P039-Tg002 Rhinoviruses (RV) VP3 common cold GMP-IVD-P039-Tg002-Ag01:
Recombinant Rhinoviruses (RV) VP3 Protein		 Rhinoviruses (VP3) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in VP3 level test of Infectious disease(common cold) and related syndrome evaluation. GMP-IVD-P039-Tg002-Ab01;
GMP-IVD-P039-Tg002-Ab02:
Anti-Rhinoviruses (RV) VP3 mouse monoclonal antibody (mAb)		 Rhinoviruses (VP3) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Rhinoviruses (VP3) antibodies in VP3 level test of Infectious disease (common cold) and related syndrome evaluation. Picture loading failed.

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dengue nonstructural 1 (DEN-NS1)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P040-Tg001 dengue nonstructural 1 (DEN-NS1) nonstructural protein 1 (NS1) dengue GMP-IVD-P040-Tg001-Ag01:
Recombinant dengue nonstructural 1 (DEN-NS1) nonstructural protein 1 (NS1) Protein		 dengue nonstructural 1 (nonstructural protein 1 (NS1)) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in nonstructural protein 1 (NS1) level test of Infectious disease(dengue) and related syndrome evaluation. GMP-IVD-P040-Tg001-Ab01;
GMP-IVD-P040-Tg001-Ab02:
Anti-dengue nonstructural 1 (DEN-NS1) nonstructural protein 1 (NS1) mouse monoclonal antibody (mAb)		 dengue nonstructural 1 (nonstructural protein 1 (NS1)) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other dengue nonstructural 1 (nonstructural protein 1 (NS1)) antibodies in nonstructural protein 1 (NS1) level test of Infectious disease (dengue) and related syndrome evaluation. Picture loading failed.

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Enterovirus 71 (EV71)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P041-Tg001 Enterovirus 71 (EV71) VP1 neurological diseases GMP-IVD-P041-Tg001-Ag01:
Recombinant Enterovirus 71 (EV71) VP1 Protein		 Enterovirus 71 (VP1) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in VP1 level test of Infectious disease(neurological diseases ) and related syndrome evaluation. GMP-IVD-P041-Tg001-Ab01;
GMP-IVD-P041-Tg001-Ab02:
Anti-Enterovirus 71 (EV71) VP1 mouse monoclonal antibody (mAb);
GMP-IVD-P041-Tg001-Ab03:
Anti-Enterovirus 71 (EV71) VP1 mouse monoclonal antibody (mAb)-Mouse IgM		 Enterovirus 71 (VP1) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Enterovirus 71 (VP1) antibodies in VP1 level test of Infectious disease (neurological diseases ) and related syndrome evaluation. Picture loading failed.

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streptolysin O (SLO)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P042-Tg001 streptolysin O (SLO) streptolysin O Streptococcus pyogenes infection GMP-IVD-P042-Tg001-Ag01:
Recombinant streptolysin O (SLO) streptolysin O Protein		 streptolysin O (streptolysin O) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in streptolysin O level test of Infectious disease(Streptococcus pyogenes infection) and related syndrome evaluation. GMP-IVD-P042-Tg001-Ab01;
GMP-IVD-P042-Tg001-Ab02:
Anti-streptolysin O (SLO) streptolysin O mouse monoclonal antibody (mAb)		 streptolysin O (streptolysin O) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other streptolysin O (streptolysin O) antibodies in streptolysin O level test of Infectious disease (Streptococcus pyogenes infection) and related syndrome evaluation. Picture loading failed.

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Mycoplasma pneumoniae

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P043-Tg001 Mycoplasma pneumoniae M-P1-10 pneumonia GMP-IVD-P043-Tg001-Ag01:
Recombinant Mycoplasma pneumoniae M-P1-10 Protein		 Mycoplasma pneumoniae P1 adhesion protein (M-P1-10) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in M-P1-10 level test of Infectious disease(pneumonia) and related syndrome evaluation. GMP-IVD-P043-Tg001-Ab01;
GMP-IVD-P043-Tg001-Ab02:
Anti-Mycoplasma pneumoniae M-P1-10 mouse monoclonal antibody (mAb)		 Mycoplasma pneumoniae P1 adhesion protein (M-P1-10) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Mycoplasma pneumoniae P1 adhesion protein (M-P1-10) antibodies in M-P1-10 level test of Infectious disease (pneumonia) and related syndrome evaluation. Picture loading failed.

For inquiry please click here to contact us or send email to [email protected]


Helicobacter pylori (H. pylori)

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P044-Tg001 Helicobacter pylori (H. pylori) CagA peptic ulcer and gastritis GMP-IVD-P044-Tg001-Ag01:
Recombinant Helicobacter pylori (H. pylori) CagA Protein		 Helicobacter pylori cytotoxin-related protein A (CagA) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in CagA level test of Infectious disease(peptic ulcer and gastritis) and related syndrome evaluation. GMP-IVD-P044-Tg001-Ab01;
GMP-IVD-P044-Tg001-Ab02:
Anti-Helicobacter pylori (H. pylori) CagA mouse monoclonal antibody (mAb)		 Helicobacter pylori cytotoxin-related protein A (CagA) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Helicobacter pylori cytotoxin-related protein A (CagA) antibodies in CagA level test of Infectious disease (peptic ulcer and gastritis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P044-Tg002 Helicobacter pylori (H. pylori) Flagellin A (FlaA) peptic ulcer and gastritis GMP-IVD-P044-Tg002-Ag01:
Recombinant Helicobacter pylori (H. pylori) FlaA Protein		 Helicobacter pylori flagellin A (FlaA) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in FlaA level test of Infectious disease(peptic ulcer and gastritis) and related syndrome evaluation. GMP-IVD-P044-Tg002-Ab01;
GMP-IVD-P044-Tg002-Ab02:
Anti-Helicobacter pylori (H. pylori) FlaA mouse monoclonal antibody (mAb)		 Helicobacter pylori flagellin A (FlaA) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Helicobacter pylori flagellin A (FlaA) antibodies in FlaA level test of Infectious disease (peptic ulcer and gastritis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P044-Tg003 Helicobacter pylori (H. pylori) Flagellin B (FlaB) peptic ulcer and gastritis GMP-IVD-P044-Tg003-Ag01:
Recombinant Helicobacter pylori (H. pylori) FlaB Protein		 Helicobacter pylori flagellin B (FlaB) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in FlaB level test of Infectious disease(peptic ulcer and gastritis) and related syndrome evaluation. GMP-IVD-P044-Tg003-Ab01;
GMP-IVD-P044-Tg003-Ab02:
Anti-Helicobacter pylori (H. pylori) FlaB mouse monoclonal antibody (mAb)		 Helicobacter pylori flagellin B (FlaB) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Helicobacter pylori flagellin B (FlaB) antibodies in FlaB level test of Infectious disease (peptic ulcer and gastritis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P044-Tg004 Helicobacter pylori (H. pylori) Vac A peptic ulcer and gastritis GMP-IVD-P044-Tg004-Ag01:
Recombinant Helicobacter pylori (H. pylori) Vac A Protein		 Helicobacter pylori vacuolar cytotoxin A (Vac A) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in Vac A level test of Infectious disease(peptic ulcer and gastritis) and related syndrome evaluation. GMP-IVD-P044-Tg004-Ab01;
GMP-IVD-P044-Tg004-Ab02:
Anti-Helicobacter pylori (H. pylori) Vac A mouse monoclonal antibody (mAb)		 Helicobacter pylori vacuolar cytotoxin A (Vac A) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Helicobacter pylori vacuolar cytotoxin A (Vac A) antibodies in Vac A level test of Infectious disease (peptic ulcer and gastritis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P044-Tg005 Helicobacter pylori (H. pylori) Ure B peptic ulcer and gastritis GMP-IVD-P044-Tg005-Ag01:
Recombinant Helicobacter pylori (H. pylori) Ure B Protein		 Helicobacter pylori urease B (Ure B) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in Ure B level test of Infectious disease(peptic ulcer and gastritis) and related syndrome evaluation. GMP-IVD-P044-Tg005-Ab01;
GMP-IVD-P044-Tg005-Ab02:
Anti-Helicobacter pylori (H. pylori) Ure B mouse monoclonal antibody (mAb)		 Helicobacter pylori urease B (Ure B) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Helicobacter pylori urease B (Ure B) antibodies in Ure B level test of Infectious disease (peptic ulcer and gastritis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P044-Tg006 Helicobacter pylori (H. pylori) HSP peptic ulcer and gastritis GMP-IVD-P044-Tg006-Ag01:
Recombinant Helicobacter pylori (H. pylori) HSP Protein		 Helicobacter pylori heat shock protein (HSP) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in HSP level test of Infectious disease(peptic ulcer and gastritis) and related syndrome evaluation. GMP-IVD-P044-Tg006-Ab01;
GMP-IVD-P044-Tg006-Ab02:
Anti-Helicobacter pylori (H. pylori) HSP mouse monoclonal antibody (mAb)		 Helicobacter pylori heat shock protein (HSP) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Helicobacter pylori heat shock protein (HSP) antibodies in HSP level test of Infectious disease (peptic ulcer and gastritis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P044-Tg007 Helicobacter pylori (H. pylori) outer membrane protein 1 (OMP-1) peptic ulcer and gastritis GMP-IVD-P044-Tg007-Ag01:
Recombinant Helicobacter pylori (H. pylori) OMP-1 Protein		 Helicobacter pylori outer membrane protein 1 (OMP-1) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in OMP-1 level test of Infectious disease(peptic ulcer and gastritis) and related syndrome evaluation. GMP-IVD-P044-Tg007-Ab01;
GMP-IVD-P044-Tg007-Ab02:
Anti-Helicobacter pylori (H. pylori) OMP-1 mouse monoclonal antibody (mAb)		 Helicobacter pylori outer membrane protein 1 (OMP-1) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Helicobacter pylori outer membrane protein 1 (OMP-1) antibodies in OMP-1 level test of Infectious disease (peptic ulcer and gastritis) and related syndrome evaluation. Picture loading failed.
GMP-IVD-P044-Tg008 Helicobacter pylori (H. pylori) outer membrane protein 2 (OMP-2) peptic ulcer and gastritis GMP-IVD-P044-Tg008-Ag01:
Recombinant Helicobacter pylori (H. pylori) OMP-2 Protein		 Helicobacter pylori outer membrane protein 3 (OMP-2) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in OMP-2 level test of Infectious disease(peptic ulcer and gastritis) and related syndrome evaluation. GMP-IVD-P044-Tg008-Ab01;
GMP-IVD-P044-Tg008-Ab02:
Anti-Helicobacter pylori (H. pylori) OMP-2 mouse monoclonal antibody (mAb)		 Helicobacter pylori outer membrane protein 3 (OMP-2) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Helicobacter pylori outer membrane protein 3 (OMP-2) antibodies in OMP-2 level test of Infectious disease (peptic ulcer and gastritis) and related syndrome evaluation. Picture loading failed.

For inquiry please click here to contact us or send email to [email protected]


Prion

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P045-Tg001 Prion PrP Transmissible spongiform encephalopathies GMP-IVD-P045-Tg001-Ag01:
Recombinant Prion PrP Protein		 Prion (PrP) antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in PrP level test of Infectious disease(Transmissible spongiform encephalopathies) and related syndrome evaluation. GMP-IVD-P045-Tg001-Ab01;
GMP-IVD-P045-Tg001-Ab02:
Anti-Prion PrP mouse monoclonal antibody (mAb)		 Prion (PrP) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Prion (PrP) antibodies in PrP level test of Infectious disease (Transmissible spongiform encephalopathies) and related syndrome evaluation. Picture loading failed.

For inquiry please click here to contact us or send email to [email protected]


SARS-CoV2

Cat No. Pathogen Target Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-IVD-P049-Tg001 SARS-CoV2 Nucleocapsid COVID-19 GMP-IVD-P048-Tg001-Ag01:
Recombinant SARS-CoV2 Nucleocapsid Protein		 SARS-CoV2 Nucleocapsid antibodies binding, Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays as control material in Nucleocapsid level test of Infectious disease(COVID-19) and related syndrome evaluation. GMP-IVD-P048-Tg001-Ab01;
GMP-IVD-P048-Tg001-Ab02:
Anti-SARS-CoV2 Nucleocapsid mouse monoclonal antibody (mAb)		 SARS-CoV2 Nucleocapsid antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other SARS-CoV2 Nucleocapsid antibodies in Nucleocapsid level test of Infectious disease (COVID-19) and related syndrome evaluation. Picture loading failed.

For inquiry please click here to contact us or send email to [email protected]


Ribavirin(RBV)

Cat No. Species Biomarker Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-SMT-168 Human Ribavirin(RBV) Hepatitis C Virus, Respiratory Syncytial Virus (RSV) GMP-SMT-168-Ag01:
BSA-Ribavirin(RBV)
GMP-SMT-168-Ag02:
OVA-Ribavirin(RBV) 		Competitive immunoassay-validated hapten-carrier conjugates BSA-&OVA-Ribavirin(RBV), Ribavirin(RBV) antibodies binding, Immunogen in Competitive immunoassay validation, Elisa, lateral-flow tests,and other immunoassays as control material in RBV level test of Infectious disease (Hepatitis C Virus, Respiratory Syncytial Virus (RSV)) and related syndrome evaluation. GMP-SMT-168-Ab01:
Anti-Ribavirin(RBV) mouse monoclonal antibody(mAb)
GMP-SMT-168-Ab02:
Anti-Ribavirin(RBV) human monoclonal antibody(mAb)		 Ribavirin(RBV) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Ribavirin(RBV) antibodies in RBV level test of Infectious disease (Hepatitis C Virus, Respiratory Syncytial Virus (RSV)) and related syndrome evaluation. Picture loading failed.

For inquiry please click here to contact us or send email to [email protected]


Amantadine(AM)

Cat No. Species Biomarker Disease Cat No.of Antigen Bioactivity validation of Antigen Cat No.of Antibodies Bioactivity validation of Antibodies Order
GMP-SMT-169 Human Amantadine(AM) Influenza A, Parkinson's disease GMP-SMT-169-Ag01:
BSA-Amantadine(AM)
GMP-SMT-169-Ag02:
OVA-Amantadine(AM) 		Competitive immunoassay-validated hapten-carrier conjugates BSA-&OVA-Amantadine(AM), Amantadine(AM) antibodies binding, Immunogen in Competitive immunoassay validation, Elisa, lateral-flow tests,and other immunoassays as control material in AM level test of Infectious disease/Neurodegenerative diseases (Influenza A, Parkinson's disease) and related syndrome evaluation. GMP-SMT-169-Ab01:
Anti-Amantadine(AM) mouse monoclonal antibody(mAb)
GMP-SMT-169-Ab02:
Anti-Amantadine(AM) human monoclonal antibody(mAb)		 Amantadine(AM) antigen binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with other Amantadine(AM) antibodies in AM level test of Infectious disease/Neurodegenerative diseases (Influenza A, Parkinson's disease) and related syndrome evaluation. Picture loading failed.

For inquiry please click here to contact us or send email to [email protected]


GeneMedi and other company's P24 antibody pairs validation with HIV PSV in sandwich ELISA

Picture loading failed.

Figure. GeneMedi and other company’s P24 antibody pairs validation with HIV PSV (GMVP-LVc10) in sandwich ELISA. GeneMedi's P24 antibody pair has a larger linear range and better sensitivity, and represents the best EC50. GeneMedi’s Ab01: GMP-IVD-P003-Tg001-Ab01, GeneMedi’s Ab02: GMP-IVD-P003-Tg001-Ab02.

Abstract

Infectious diseases are a significant burden on public health and economic stability of societies all over the world. They have been among the leading causes of death and disability and presented growing challenges to health security and human progress for centuries. Infectious diseases are generally caused by microorganisms. The routes of them entry into host is mostly by the mouth, eyes, genital openings, nose, and the skin. Damage to tissues mainly results from the growth and metabolic processes of infectious agents intracellular or within body fluids, with the production and release of toxins or enzymes that interfere with the normal functions of organs and/or systems [1]. Advances in basic science research and development of molecular technology and diagnostics have enhanced understanding of disease etiology, pathogenesis, and molecular epidemiology, which provide basis for appropriate detection, prevention, and control measures as well as rational design of vaccine [2]. The diagnosis of infectious diseases is particularly critical for the prevention and control of the epidemic. Here we introduce the insights and detection methods of infectious disease, aiming to provide some helps for clinical diagnosis as well as epidemic prevention and control of infectious diseases.

1. Introduction of human infectious diseases caused by living pathogens

Infectious diseases arise upon contact with an infectious agent. Five major infectious agents have been identified: bacteria, viruses, fungi, protozoans and parasites [3, 4]. Various factors can be identified that create opportunities for infectious agents to invade human hosts. These include global urbanization, increase in population density, poverty, social unrest, travel, land clearance, farming, hunting, keeping domestic pets, deforestation, climate change, and other human activities that destroy microbial habitat [5, 6]. Human engagement in activities that interfere with ecological and environmental conditions continues, thereby increasing the risk of contact with new pathogens. These pathogens are mostly transmitted though intermediate animal hosts such as rodents [7, 8], which gain increased contact with humans as a result of environmental and human behavioral factors. In most cases, a combination of risk factors accounts for infectious disease emergence and/or outbreak of epidemic. Here we list some past emerging infectious disease epidemics and probable factors for the outbreak in Table 1.

Table1. Some past infectious disease epidemics and possible outbreak factors
Year  Emerging disease  Pathogenic agent  Main probable factor Genemedi's Diagnostics antibodies and antigens
2019 2019-novel-coronavirus pneumonia 2019-nCoV/SARS-CoV-2 Dynamic balances and imbalances, within complex globally distributed ecosystems comprising humans, animals, pathogens, and the environment. May be because of hunting and feeding on infected wild animals (viverrids) Antigens: Nucleocapsid (N protein), Spike(S protein), RBD, S1+S2 ECD, Envelope (E protein), 3C-like Proteinase (Mpro), RdRP(Nsp12), etc.
Antibodies: N protein antibody (

GMP-V-2019nCoV-NAb001~004) , Spike protein antibody (

GMP-V-2019nCoV-SAb001~004)

1976-2020 Ebola haemorrhagic fever Filovirus Ebola virus Rainforest penetration by humans/close
contact with infected game (hunting) or
with host reservoirs (bats)/infected
biological products/nosocomial/needle
spread 		Antibodies: Anti-ebola virus (EV) nucleoprotein (NP) mouse monoclonal antibody (mAb)
Antigens: Recombinant ebola virus (EV) nucleoprotein (NP) Protein
1889, 1890,
1918, 1957 		Pandemic Influenza Paramyxovirus influenza A Animal-human virus reassortment and
antigenic shift 		Antibodies: Anti-Influenza A NP mouse monoclonal antibody
Antigens: Recombinant Influenza A NP Protein (Flu A/B, His Tag)
2003 Severe acute respiratory syndrome (SARS) SARS Coronavirus Hunting and feeding on infected wild
animals (viverrids)
1997 Highly pathogenic avian influenza (HPAI) H5N1 virus Animal-animal influenza virus gene
reassortment; emergence of H5N1 avian
influenza, extensive chicken farming 		Antibodies: Anti-Avian Influenza Virus Type A H5N1 subtype Nucleocapsid Protein (NP) mouse monoclonal antibody (mAb)
Anti-Avian Influenza Virus Type A H5N1 subtype Haemagglutinin (HA) mouse monoclonal antibody (mAb)
Antigens: Recombinant Avian Influenza Virus Type A H5N1 subtype NP Protein
Recombinant Avian Influenza Virus Type A H5N1 subtype Haemagglutinin (HA) Protein
1996 Haemorrhagic colitis Escherichia coli O157:H7 Ingestion of contaminated food,
undercooked beef, and raw milk
1988 Herpes Herpes simplex virus 1/2(HSV-1/HSV-2) Indirect contact transmission, saliva, liquid from herpes, blood,mother to baby at birth. Antibodies: Anti-herpes simplex virus (HSV) mouse monoclonal antibody (mAb)
Antigens: Recombinant herpes simplex virus (HSV) Protein
1987 Rift Valley fever (RVF) Bunyavirus RVF virus Dramatic increase in mosquito vector
breeding sites (by dam filling); weather
(rainfall) and cattle migration (guided by
artificial water holes) 		Antibodies: Anti-Rift Valley Fever (RVF) nucleoprotein (NP) mouse monoclonal antibody (mAb)
Antigens: Recombinant Rift Valley Fever (RVF) nucleoprotein (NP) Protein
1987 Hepatitis C Hepatitis c virus (HCV) Blood, acupuncture, drug taking, etc Antibodies: Anti-hepatitis C virus (HCV) Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) mouse monoclonal antibody (mAb)
Antigens: Recombinant hepatitis C virus (HCV) Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag) Protein
1983 Crimean-Congo haemorrhagic fever CCHF virus Ecological changes favouring increased
human exposure to ticks of sheep and
small wild animals
1981 Acquired immunodeficiency syndrome (AIDS) Human immunodeficiency virus (HIV) Sexual contact/exposure to blood or
tissues of an infected person 		Antibodies: Anti-Human immunodeficiency virus 1 (HIV-1) GP41 Protein mouse monoclonal antibody (mAb)
Antigens: Recombinant Human immunodeficiency virus 1 (HIV-1) GP41 Protein Protein
1976 Malaria Plasmodium falciparum Human behaviour/rainfall and drainage
problems/mosquito breeding/neglect of
eradication policy, economics, and
growing interchange of populations 		Antigens: Recombinant Plasmodium merozoite surface protein (MSP) Protein
Recombinant Plasmodium Circumsporozoite Protein (CSP) Protein
Antibodies: Anti-Plasmodium merozoite surface protein (MSP) mouse monoclonal antibody (mAb)
Anti-Plasmodium Circumsporozoite Protein (CSP) mouse monoclonal antibody (mAb)
1969 Lassa fever Arenavirus Lassa virus Hospital exposure to index case—rodent
exposure
1965 Hepatitis B Hepatitis b virus (HBV) sexual contact, sharing needles, syringes, or other drug-injection equipment, mother to baby at birth. Antigens: Recombinant Hepatitis b virus (HBV) HBsAg Protein
Recombinant Hepatitis B virus (HBV) HBeAg Protein
Recombinant Hepatitis B virus (HBV) HBcAg Protein
Antibodies: Anti-Hepatitis B virus (HBV) HBsAg mouse monoclonal antibody (mAb)
Anti-Hepatitis B virus (HBV) HBeAg mouse monoclonal antibody (mAb)
Anti-Hepatitis B virus (HBV) HBcAg mouse monoclonal antibody (mAb)
1959 Bolivian haemorrhagic fever (BHF) ArenavirusMachupo virus Population increase of rats gathering food
1958 Argentine haemorrhagic fever  ArenavirusJunin virus  Changes in agricultural practices of corn harvest (maize mechanization)
1953 Dengue haemorrhagic fever (DHF) Dengue viruses 1, 2, 3, and 4 Increasing human population density in
cities in a way that favours vector
breeding sites (water storage)
1949 Cervical cancer Human papilloma virus (HPV) Contact infection, Sexual contact Antibodies: Recombinant Human papilloma virus (HPV) HPV 16 L1 capsid protein Protein
Antibodies: Anti-Human papilloma virus (HPV) HPV 16 L1 capsid protein mouse monoclonal antibody (mAb)

2. The strategies used in diagnosis of human Infectious diseases


2.1 Molecular Methods


The development of molecular methods for the direct identification of a specific viral genome from the clinical sample is one of the greatest achievements of the 21st century. Clearly nucleic acid amplification techniques including Reverse Transcription-Polymerase Chain Reaction (RT-PCR), nucleic acid sequence-based amplification (NASBA) and Lawrence Livermore Microbial Detection Array (LMDA) are proven technology leaders for rapid detection and molecular identification for most known human viruses [9].

RT-PCR assays for virus detection provides faster results than end-point assays and in many cases have sensitivities equal to or better than culture [10]. The novel coronavirus, 2019-nCoV, was detected through real-time RT-PCR with primers against two segments of its RNA genome [11]. The particular primer sets and specific guideline for detection of COVID-19 through RT-PCR were made available by the Center for Disease Control (CDC) USA, according to CDC [12]. However, high mutation rates may lead to extensive changes in viral nucleic acid sequences making dedicated PCR primer use irrelevant, therefore there is high demand for the development of rapid and universal virus identification and detection technologies. In contrast, although NASBA assay is considered sensitive; it has not been widely used because of the difficulties in the preparation of NASBA master mix in-house and the high cost of commercial kits. A new molecular biology-based microbial detection method for rapid identification of multiple virus types in the same sample has been developed by a research group at Lawrence Livermore National Laboratory. Lawrence Livermore Microbial Detection Array (LLMDA) detects viruses using probes against genomic DNA sequence within 24 hours [13,14]. In addition, the oligonucleotide probes were selected to enable detection of novel, divergent species with homology to sequenced organisms [14].

Picture loading failed. Figure 1. Principle of RT-PCR.

2.2 Immuno-assays


The nucleic acid Diagnostics tool currently employed is with good sensitivity and excellent specificity. However, due to its high false negative, time-consuming, high level equipment and technical personnel demand, the immunological antigen or antibody detection has been paid more and more attention because of its quick detection speed, low and simple technical requirements of detection. At present, the detection methods mainly include Enzyme-linked immunosorbent assays (ELISAs), colloidal gold immunochromatography (GICA) and magnetic particle chemiluminescence.

2.2.1 Enzyme-Linked Immunosorbent Assays (ELISA)

Enzyme-linked immunosorbent assays (ELISAs) incorporate the sensitivity of simple enzyme assays with the specificity of antibodies, by employing antigens or antibodies coupled to an easily-assayed enzyme. As such ELISA is much more rapid method than immunoblotting to detect specific viral protein from a cell, tissue, organ, or body fluid. There are two main variations of ELISAs: antigen-capture ELISA (detecting viral proteins), involve attachment of a capture antibody to a solid matrix for the viral protein of interest, while antibody-capture ELISA measures the specific antibody level in a sample, by coating viral antigen protein on a solid surface. There are two principles based on antigen-capture and antibody-capture ELISAs. In a general, ELISAs are considered a highly sensitive method that can detect a fairly low number of proteins at the range of picomolar to nanomolar range (10-12 to 10-9 moles per liter). ELISA has been one of the most widely used serologic tests for detecting antibody to HIV-1. ELISA method was found useful as a Diagnostics tool to detect influenza viral antigen much quicker than other conventional virus detection methods [15]. In another previous study, comparison of ELISA, with conventional methods has demonstrated ELISA superiority for the rapid detection and identification of influenza A virus [16]. A simplified and standardized neutralization enzyme immunoassay (Nt-EIA) was developed to detect measles virus growth in Vero cells and to quantify measles neutralizing antibody [17]. Newer EIA formats for hepatitis C virus diagnostics have been constantly evaluated [18,19]. As such ELISAs are being used for plethora of application both in experimental and Diagnostics virology including HIV-1, dengue, and influenza [20-22]. On the other hand, although rapid than traditional plaque assays or TCID50, ELISA assays sometimes could be quite expensive, due to the cost of reagents used. Unfortunately, sometimes required antibodies may not be commercially developed as well. In contrast, attempts to develop antibodies in-house may be quite expensive. Additional variability may also be introduced due to high background signals generated by non-specific binding, or cross-reactivity with non-viral protein targets.

Picture loading failed. Figure 2. A schematic representation of two principles based on antigen or antibody capture ELISA[23]

2.2.2 Colloidal gold immunochromatography (GICA)

Based on the specific immune response of antigen and antibody, colloidal gold particles were used as one of the tracer markers. Driven by solvent chromatography, the markers had an immune response on the C/T line, and the detection results could be obtained according to the color of the T line. GICA samples can be whole blood, serum or plasma, and studies have shown that the colloidal gold reagent has a high consistency in detecting whole blood, plasma or serum [24]. At present, there are seven kinds of colloidal gold kits approved by the State Food and Drug Administration, which are all detection antibodies, but there is no detection kit for antigens. RT-PCR was used as the control method, and the sensitivity and specificity of IgM/IgG antibody were different, and the highest detection rate of the two combined detection was 66.1% (125/189) [25]. This method can be used for enterprise resumption, students return to school, community crowd screening and other scenarios. Only a drop of fingertip blood is needed, and the detection results can be observed visually in 15 minutes, which is rapid and simple without special instruments. However, the detection has its disadvantages such as window period, without quantification, exposure risk, low sensitivity and vulnerability to environmental factors, and nucleic acid detection combination result is required for verification.

Picture loading failed. Figure 3. Scheme showing the general steps in the antibody-based diagnosis of viral infections from blood samples[26]

2.2.3 Magnetic particle chemiluminescence

Magnetic particle chemiluminescence is an emerging technique to capture specific IgM/IgG antibodies in samples using magnetic particles fixed on the surface of recombinant antigens. The antigen-antibody complex was precipitated by external magnetic field, and the captured antigen-antibody complex was identified by enzyme-labeled secondary antibody, and the luminescent intensity was determined by chemiluminescence instrument after adding the luminescent agent, and then quantitative analysis was carried out. It is characterized by high sensitivity, high specificity and wide detection range, etc. There are currently seven approved magnetic particle chemiluminescence detection kits, the first one developed by Bioscience, with an automatic chemiluminescence analyzer, capable of detecting at a speed of 240 T/H with an initial reporting time of 30 min [27].

2.3 Viral Culture


Virus culture, isolation and identification are the gold standards for laboratory identification of pathogens. However, viral culture results do not yield timely results to inform clinical management. Shell-vial tissue culture results may take 1-3 days, while traditional tissue-cell viral culture results may take 3-10 days. Due to the long incubation time, high technical requirements, and must be carried out in a level III safe biological laboratory, it is not suitable for rapid virus diagnosis during the epidemic period [28].

2.4 Immunofluorescence (IF) Assay


Immunofluorescence (IF) technique is widely used for rapid detection of virus infections by identifying virus antigens in clinical specimens. IF staining is usually considered very rapid (about 1 to 2 hr) and overall gives a sensitive and specific viral identification [29-32]. Unfortunately, IF technique may not able to confirm the identity of all virus strains, for instance viruses of the “enterovirus” group; since most monoclonal antibodies (MAbs) for enteroviral identification have been shown to lack sensitivity, while cross-reactivity with rhinoviruses is extremely common [33]. In contrast, IF has been successfully used for better management of influenza virus infection and surveillance of influenza virus activity [30, 31]. As recommended by CDC, when influenza activity is low, positive results should be confirmed by direct immunofluorescence assay (DFA), viral culture, or RT-PCR, as false positive test results are more likely; while during peak influenza activity confirmatory testing using DFA, viral culture, or PCR must always be considered because a negative test may not rule out influenza viral infection. Interestingly, although IF is generally considered less sensitive then ELISA and PCR, a recent publication reports DFA as an optimal method for rapid identification of varicella-zoster virus (VZV), when compared with conventional cell culture [34]. In contrast, the Herpes simplex virus (HSV) DFA test accuracy was found very low (sensitivity 61%, specificity 99%), when tested to identify mucocutaneous HSV infection in children [35]. Furthermore, a monoclonal antibody designated CHA 437 was developed against HSV showed no cross-reactivity against the varicella-zoster virus, cytomegalovirus, or Epstein-Barr virus, however direct specimen testing resulted in overall low sensitivity (84.6%) and specificity (95.7%) [36]. On the other hand, an antigen detection assay for severe acute respiratory syndrome (SARS) coronavirus (CoV) could detect SARS-CoV in 11 out of 17 (65%) samples from SARS patients. As such IF technique is well-accepted laboratory diagnostics test, however, sometime these assays could be quite expensive, due to the cost of antibodies used. Additional variability may also be introduced due to non-specific binding, or cross-reactivity of commercially available antibodies [37].

As such IF technique is well-accepted laboratory diagnostics test, however, sometime these assays could be quite expensive, due to the cost of antibodies used. Additional variability may also be introduced due to non-specific binding, or cross-reactivity of commercially available antibodies.

Picture loading failed. Figure 4. Immunofluorescence staining of vaccinia virus infected cell [38]. Areas of virus assembly within the cell are pink.
Host and viral DNA (deoxyribonucleic acid) is blue. The host cell's DNA is contained within its nucleus (large oval). Actin protein
filaments, which make up part of the cytoskeleton, are green.

2.5 Immunoblotting (WB)


Immunoblotting technique detects specific viral proteins isolated from a cell, tissue, organ, or body fluid. The development of sensitive and specific tests for human immunodeficiency virus type 1 (HIV-1) progressed rapidly after this retrovirus was found to be responsible for causing AIDS [39]. Immunoblotting has been one of the reference confirmatory tests for the diagnosis of HIV infection or after inconclusive enzyme immunoassay (EIA) results. Although difficulty in interpretation of immunoblotting results and the cost led to a reduction in overall use of WB technique, nevertheless immunoblots are still commonly used for various purposes, including clinical diagnosis of HIV-1, seroprevalence surveys, and for blood-donor screening. In addition, immunoblot assays have been used to confirm the anti-hepatitis C virus (HCV) reactivity [40]. In recent years immunoblotting has been established as an important prerequisite for the functional studies to understand protein composition of the purified viral particles, since it allows the analysis of specific proteins which result in better understanding of the infection process and the pathogenesis of viruses [41,42].

2.6 Transmission Electron Microscopy (TEM)


Most viruses are very small to be seen directly under a light microscope, and therefore could only be viewed with TEM (transmission electron microscopy). In 1948, smallpox and chicken pox were first differentiated by TEM [43] and thereafter early virus classifications depended heavily on TEM analysis. In particular many intestinal viruses were discovered by negative staining TEM microscopy [44, 45]. Although TEM has gradually been replaced by more sensitive methods such as PCR, nevertheless it still remains essential for several aspects of virology including discovery, description and titration of viruses. One of the major advantages of using TEM is that it does not require virus-specific reagents; this is of particular importance in an outbreak setting where the etiologic agent is unknown and therefore specific reagents may not be available to determine correct detection tests. Negative stained TEM technique continues to be a valuable tool for the discovery and identification of novel viruses including Ebola virus, henipavirus (Hendra and Nipah) and SARS [46-50]. A human monkeypox outbreak was detected in the US by TEM [51]. Nevertheless, due to the high instrument cost and the amount of space and facilities required, TEM is still only available in certain facilities.

Picture loading failed. Figure 5. Transmission Electron Microscopy of hantavirus virions[52]

Summary

Infectious diseases are a real public health threat, outbreaks can have serious social, political, and economic effects. A complex number of factors relating to human behavior and activities, pathogen evolution, poverty, and changes in the environment as well as dynamic human interactions with animals have been found to contribute to infectious disease emergence and transmission. Aggressive research is warranted to unravel important characteristics of pathogens necessary for diagnostics, therapeutics, and vaccine development. Here we describe some strategies for the diagnosis of human infectious diseases, hoping to be helpful for clinical diagnosis and epidemic prevention and control of infectious diseases. To date, multiple Diagnostics techniques have been developed. Various Diagnostics tools show both significances and limitations. Conventional approaches to quantify infective viral particles are labor-intensive, time-consuming, and often associated with poor reproducibility. Immunological tests generally provide quick results, however, is quite expensive due to the requirement of antigen-specific antibody. While RT-PCR may be able to provide results within a matter of hours, it is laborious, requires a skilled operator, and is sensitive to contamination. TEM-based quantification, although highly accurate in determining the shape and the total number of viral particles, often considered time-consuming, extremely expensive and impractical for high sample numbers. Moreover, TEM sample preparation is tedious, and the technique requires sophisticated instrument and a skilled operator. To alleviate these limitations, there is still a need to develop new cost-effective analytical methods that can allow users to quickly and easily determine virus concentrations and reduce constrictions coupled with current assays. Nevertheless, any such emerging methods must be carefully evaluated in terms of their efficiency, precision and linear range. The evaluation of each Diagnostics technique and approval from the FDA are necessary before practical application.

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