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Products list: paired diagnostics grade antibodies (monoclonal antibody, mab) and antigens for infectious disease rapid test kit

Cytokine release syndrome (CRS) is an acute systemic inflammatory syndrome characterized by fever and multiple organ dysfunction.

Genemedi produces core diagnostic ingredients for test of infectious diseases and related syndrome.

GeneMedi offers paired diagnostics grade antibodies (monoclonal antibody,mab)and antigens for infectious disease rapid test kit including infection of HIV/AIDS,Hepatitis C virus(HCV), Influenza A/B,Treponema Pallidum caused Syphilis,Helicobacter pylori (H. pylori) Bacteria, Herpes simplex virus 1/2(HSV-1/HSV-2),Cytomegalovirus (CMV),rubella virus,toxoplasma gondii and so on.

All the antibodies of inflammation and CRS test are suitable for in functional ELISA, and other immunoassays in diagnostics. The antibody can act as a capture antibody and detection antibody.

Classification: Astrovirus (Aastrovirus) human adenovirus anthrax bacillus acute respiratory infectious diseases Jejunum campylobacter candida Cytomegalovirus (CMV) Cryptosporidium (Crypto) parvum EB virus ebola virus (EV) Food source pathogenic bacteria resistant FluA FluB H. pylori Hepatitis b virus (HBV) HCV HIV1 HIV2 Human papilloma virus (HPV) herpes simplex virus HSV-1 HSV-2 Listeria monocytogenes Mycobacterium tuberculosis malaria Norovirus (NV, also called Winter Vomiting Bug) Prion Rift Valley Fever (RVF) rotavirus rubella virus salmonella Sexually transmitted diseases (STDs) TP(Treponema Pallidum) toxoplasma Vaccinia virus (cowpox virus) Vibrio cholerae West Nile virus (WNV)



Cat No. Antibody/Antigen Name Isotypes Isotypes Bioactivity validation Order
GMP-Aastrovirus-1AbMouse anti-Astrovirus (Aastrovirus) monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, rovirusteral-flow tests,and other immunoassays in[Astrovirus (Aastrovirus)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-adenovirus-1AbMouse anti-human adenovirus monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, anteral-flow tests,and other immunoassays in[human adenovirus)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-anthrax-1AbMouse anti-anthrax bacillus monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays in[anthrax bacillus]level test in human infectious disease diagnositcs.Picture loading failed.
GMP-ARTI-1AbMouse anti-acute respiratory infectious diseases monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays in[acute respiratory infectious diseases)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Campylobacter-1AbMouse anti-Jejunum campylobacter monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, unumteral-flow tests,and other immunoassays in[Jejunum campylobacter)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-candida-1AbMouse anti-candida monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, didateral-flow tests,and other immunoassays in[candida)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-CMV-1AbMouse anti-cytomegalovirus monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, omegalovirusteral-flow tests,and other immunoassays in[cytomegalovirus)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-CMV-Ag01Recombinant Cytomegalovirus (CMV) antigen ProteinE.coliRecombinant AntigenCytomegalovirus (CMV) Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Cytomegalovirus (CMV) infection test. Picture loading failed.
GMP-Crypto-1AbMouse anti-Cryptosporidium (Crypto) parvum monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, omegalovirusteral-flow tests,and other immunoassays in[Cryptosporidium (Crypto) parvum] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-EBV-1AbMouse anti-EB virus monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, teral-flow tests,and other immunoassays in[EB virus)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-EV-1AbMouse anti-ebola virus (EV) monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays in[ebola virus (EV)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-FluA-Ab01Anti-Influenza A NP mouse monoclonal antibody(mAb)HybridomaMouse IgGInfluenza A NP(nucleoprotein) Proteinbinding, ELISA validated as capture antibody and detection antibody Pair recommendation with GMP-FluA-Ab02 in Influenza A testPicture loading failed.
GMP-FluA-Ab02Anti-Influenza A NP mouse monoclonal antibody(mAb)HybridomaMouse IgGInfluenza A NP(nucleoprotein) Protein binding, ELISA validated as capture antibody and detection antibody Pair recommendation with GMP-FluA-Ab01 in Influenza A testPicture loading failed.
GMP-FluA-Ag01Recombinant Influenza A NP Protein (Flu A, His Tag)E.coliRecombinant AntigenInfluenza A NP(nucleoprotein) Protein Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Influenza A testPicture loading failed.
GMP-FluB-Ab01Anti-Influenza B NP mouse monoclonal antibody (mAb)HybridomaMouse IgGInfluenza B NP(nucleoprotein) Protein binding, ELISA validated as capture antibody and detection antibody Pair recommendation with GMP-FluB-Ab02 in Influenza B testPicture loading failed.
GMP-FluB-Ab02Anti-Influenza B NP mouse monoclonal antibody (mAb)HybridomaMouse IgGInfluenza B NP(nucleoprotein) Protein binding, ELISA validated as capture antibody and detection antibody Pair recommendation with GMP-FluB-Ab01 in Influenza B testPicture loading failed.
GMP-FluB-Ag01Recombinant Influenza B NP Protein (Flu B, His Tag)E.coliRecombinant AntigenInfluenza B NP(nucleoprotein) Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Influenza B testPicture loading failed.
GMP-Foodborne pathogens-1AbMouse anti-Food source pathogenic bacteria resistant monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, dteral-flow tests,and other immunoassays in[Food source pathogenic bacteria resistant)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-H. pylori-Ab01Anti-Helicobacter pylori (H. pylori) bacteria monoclonal antibody (mAb)HybridomaMouse IgGELISA validated as capture antibody and detection antibodyPair recommendation with GMP-H. pylori-Ab02 in Helicobacter pylori(H. Pylori) Bacteria infection Symptoms testPicture loading failed.
GMP-H. pylori-Ab02Anti-Helicobacter pylori (H. pylori) bacteria monoclonal antibody (mAb)HybridomaMouse IgGELISA validated as capture antibody and detection antibodyPair recommendation with GMP-H. pylori-Ab02 in Helicobacter pylori(H. Pylori) Bacteria infection Symptoms testPicture loading failed.
GMP-H. pylori-Ag01Recombinant Helicobacter pylori (H. pylori) antigen ProteinE.coliRecombinant AntigenHelicobacter pylori (H. pylori) Bacteria Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays Pair recommendation with GMP-H. pylori-Ag02 in Helicobacter pylori(H. Pylori) Bacteria infection Symptoms testPicture loading failed.
GMP-H. pylori-Ag02Recombinant Helicobacter pylori (H. pylori) antigen ProteinE.coliRecombinant AntigenHelicobacter pylori (H. pylori) Bacteria Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays Pair recommendation with GMP-H. pylori-Ag01 in Helicobacter pylori(H. Pylori) Bacteria infection Symptoms testPicture loading failed.
GMP-HBV-1AbMouse anti-Hepatitis b virus (HBV) monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, atitisteral-flow tests,and other immunoassays in[Hepatitis b virus (HBV)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-HCV-Ab01Anti-HCV core antigen (HCcAg) monoclonal antibody (mAb)HybridomaMouse IgGHCV core antigen (HCcAg) Protein binding, ELISA validated as capture antibody and detection antibody in Hepatitis C test..Picture loading failed.
GMP-HCV-Ag01Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag)E.coliRecombinant AntigenHCV Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Hepatitis C test. Pair recommendation with GMP-HCV-Ag02 in Hepatitis C test.Picture loading failed.
GMP-HCV-Ag02Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag)E.coliRecombinant AntigenHCV Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Hepatitis C test. Pair recommendation with GMP-HCV-Ag01 in Hepatitis C test.Picture loading failed.
GMP-HIV1-Ag01Recombinant HIV-1 GP41 Protein (His Tag)E.coliRecombinant AntigenHIV-1 GP41 Protein Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays Pair recommendation with GMP-HIV1-Ag02 in HIV-1/AID testPicture loading failed.
GMP-HIV1-Ag02Recombinant HIV-1 GP41 Protein (His Tag)E.coliRecombinant AntigenHIV-1 GP41 Protein Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays Pair recommendation with GMP-HIV1-Ag01 in HIV-1/AIDS testPicture loading failed.
GMP-HIV1-Ab01Anti-HIV1 P24 mouse monoclonal antibody(mAb)HybridomaMouse IgGHIV1 P24 Protein binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with GMP-HIV1-Ab02 in HIV1 testPicture loading failed.
GMP-HIV1-Ab02Anti-HIV1 P24 mouse monoclonal antibody(mAb)HybridomaMouse IgGHIV1 P24 Protein binding, ELISA validated as capture antibody and detection antibody. Pair recommendation with GMP-HIV1-Ab01 in HIV1 testPicture loading failed.
GMP-HIV2-Ag01Recombinant HIV-2 GP36 Protein (His Tag)E.coliRecombinant AntigenHIV-2 Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays Pair recommendation with GMP-HIV2-Ag02 in HIV-2/AIDS testPicture loading failed.
GMP-HIV2-Ag02Recombinant HIV-2 GP36 Protein (His Tag)E.coliRecombinant AntigenHIV-2 GP36 Protein Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays Pair recommendation with GMP-HIV2-Ag01 in HIV-2/AIDS testPicture loading failed.
GMP-HPV-1AbMouse anti-Human papilloma virus (HPV) monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, anteral-flow tests,and other immunoassays in[Human papilloma virus (HPV)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-HSV-1AbMouse anti-herpes simplex virus monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, pesteral-flow tests,and other immunoassays in[herpes simplex virus)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-HSV-1-Ag01Recombinant HSV-1 antigen ProteinE.coliRecombinant AntigenHerpes simplex virus 1(HSV-1) Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Herpes simplex virus 1(HSV-1) infection test. Picture loading failed.
GMP-HSV-2-Ag01Recombinant HSV-2 antigen ProteinE.coliRecombinant AntigenHerpes simplex virus 2(HSV-2) Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Herpes simplex virus 2(HSV-2) infection test.Picture loading failed.
GMP-Listeria monocytogenes-1AbMouse anti-Listeria monocytogenes monoclonal antibodiesHybridomaMouse IgGAntibody Binding, Immunogen in Sandwich Elisa, teriateral-flow tests,and other immunoassays in[Listeria monocytogenes)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-M. tb-1AbMouse anti-Mycobacterium tuberculosis monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, obacteriumteral-flow tests,and other immunoassays in[Mycobacterium tuberculosis)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Malaria-1AbMouse Anti-malaria monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, ariateral-flow tests,and other immunoassays in[malaria)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Norovirus-1AbMouse anti-Norovirus (NV, also called Winter Vomiting Bug) monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, ovirusteral-flow tests,and other immunoassays in[Norovirus (NV, also called Winter Vomiting Bug)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-prion-1AbMouse anti-Prion monoclonal AntibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, nteral-flow tests,and other immunoassays in[Ruan Toxin)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Rift Valley Fever-1AbMouse Anti-Rift Valley Fever (RVF) Monoclonal AntibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, tteral-flow tests,and other immunoassays in[Rift Valley Fever (RVF)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Rotavirus-1AbMouse anti-rotavirus monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, avirusteral-flow tests,and other immunoassays in[rotavirus)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Rubella-1AbMouse anti-rubella virus monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, ellateral-flow tests,and other immunoassays in[rubella virus)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Rubella-Ag01Recombinant rubella virus antigen ProteinE.coliRecombinant Antigenrubella virus Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of rubella virus infection test.Picture loading failed.
GMP-Salmonella-1AbMouse anti-salmonella monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, monellateral-flow tests,and other immunoassays in[salmonella)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-STDs-1AbMouse anti-Sexually transmitted diseases (STDs) monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, uallyteral-flow tests,and other immunoassays in[Sexually transmitted diseases (STDs)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Toxo-1AbMouse Anti-toxoplasma monoclonal antibodiesHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, oplasmateral-flow tests,and other immunoassays in[toxoplasma)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Toxo-Ag01Recombinant toxoplasma gondii antigen ProteinE.coliRecombinant Antigentoxoplasma gondii Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of toxoplasma gondii infection test. Picture loading failed.
GMP-TP-1AbMouse anti-TP(Treponema Pallidum) monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, hilisteral-flow tests,and other immunoassays in[Syphilis treponema)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-TP-Ag01Recombinant TP P15-P17-P47 fusion Protein (His Tag)E.coliRecombinant AntigenTP(Treponema Pallidum) Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Syphilis test Pair recommendation with GMP-TP-Ag02,GMP-TP-Ag03, GMP-TP-Ag04 in Treponema Pallidum caused Syphilis test.Picture loading failed.
GMP-TP-Ag02Recombinant TP P15-P17-P47 fusion Protein (His Tag)E.coliRecombinant AntigenTP(Treponema Pallidum) Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Syphilis test Pair recommendation with GMP-TP-Ag01,GMP-TP-Ag03, GMP-TP-Ag04 in Treponema Pallidum caused Syphilis testPicture loading failed.
GMP-TP-Ag03Recombinant TP P15-P17-P47 fusion Protein (His Tag)E.coliRecombinant AntigenTP(Treponema Pallidum) Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Syphilis test Pair recommendation with GMP-TP-Ag01,GMP-TP-Ag02, GMP-TP-Ag04 in Treponema Pallidum caused Syphilis testPicture loading failed.
GMP-TP-Ag04Recombinant TP P15-P17-P47 fusion Protein (His Tag)E.coliRecombinant AntigenTP(Treponema Pallidum) Antibody Binding,Immunogen in Sandwich Elisa, lateral-flow tests,and other immunoassays of Syphilis test Pair recommendation with GMP-TP-Ag01, GMP-TP-Ag02, GMP-TP-Ag03 in Treponema Pallidum caused Syphilis testPicture loading failed.
GMP-Vaccinia-1AbMouse anti-Vaccinia virus (cowpox virus) monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, ciniateral-flow tests,and other immunoassays in[Vaccinia virus (cowpox virus)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-Vibrio cholerae-1AbMouse anti-Vibrio cholerae monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, rioteral-flow tests,and other immunoassays in[Vibrio cholerae)] level test in human infectious disease diagnositcs.Picture loading failed.
GMP-WNV-1AbMouse anti-West Nile virus (WNV) monoclonal antibodyHybridomaMouse IgGAntibody Binding,Immunogen in Sandwich Elisa, tteral-flow tests,and other immunoassays in[West Nile virus (WNV)] level test in human infectious disease diagnositcs-for West Nile fever.Picture loading failed.


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-HIV1-Ab01, GeneMedi’s Ab02: GMP-HIV1-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 diagnostic 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: Mouse anti-ebola virus (EV) monoclonal antibodies
1889, 1890,
1918, 1957
Pandemic Influenza Paramyxovirus influenza A Animal-human virus reassortment and
antigenic shift
Antibodies: Anti-Influenza A NP mouse monoclonal antibody
Anti-Influenza B NP mouse monoclonal antibody
Antigens: Recombinant Influenza A NP Protein (Flu A/B, His Tag)
Recombinant Influenza B 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-Influenza A NP mouse monoclonal antibody
Anti-Influenza B NP mouse monoclonal antibody
Antigens: Recombinant Influenza A NP Protein (Flu A/B, His Tag)
Recombinant Influenza B NP Protein (Flu A/B, His Tag)
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: Mouse anti-herpes simplex virus monoclonal antibodies
Antigens: Recombinant HSV-1 antigen Protein
Recombinant HSV-2 antigen 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: Mouse Anti-Rift Valley Fever (RVF) Monoclonal Antibody
1987 Hepatitis C Hepatitis c virus (HCV) Blood, acupuncture, drug taking, etc Antibodies: Anti-HCV core antigen (HCcAg) monoclonal antibody
Antigens: Recombinant HCV NS3-NS4-NS5 fusion Protein (His Tag)
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
Antigens: Recombinant HIV-1 GP41 Protein (His Tag),
Recombinant HIV-2 GP36 Protein (His Tag)
1976 Malaria Plasmodium falciparum Human behaviour/rainfall and drainage
problems/mosquito breeding/neglect of
eradication policy, economics, and
growing interchange of populations
Antibodies: Mouse Anti-malaria monoclonal antibodies
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. Antibodies: Mouse anti-Hepatitis b virus (HBV) monoclonal antibody
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: Mouse anti-Human papilloma virus (HPV) monoclonal antibody


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 diagnostic 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 diagnostic 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 diagnostic 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 diagnostic techniques have been developed. Various diagnostic 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 diagnostic technique and approval from the FDA are necessary before practical application.

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