Contact
View Knowledge Base - Diagnostic antibodies and antigens for infectious disease testing including HIV/AIDS, HCV, Influenza A/B, Syphilis, Helicobacter pylori, HSV-1/2, CMV, rubella virus, toxoplasma.>>

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.

Molecular Methods - strategie used in diagnosis of human Infectious diseases


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.

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.

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)



Reference


[1] National Institutes of Health (US) and BSC Study, Understanding Emerging and Re-emerging Infectious Diseases, National Institutes of Health (US), 2007.
[2] Nii-Trebi NI. Emerging and Neglected Infectious Diseases: Insights, Advances, and Challenges. Biomed Res Int. 2017; 2017:5245021. doi: 10.1155/2017/5245021. Epub 2017 Feb 13. PMID: 28286767; PMCID: PMC5327784.
[3] N. C. Barber and L. A. Stark, “Online resources for understanding outbreaks and infectious diseases,” CBE Life Sciences Education, vol. 14, no. 1, 2015.
[4] “Globalization and infectious diseases: a review of the linkages,” http://www.who.int/tdr/publications/documents/seb topic3.pdf.
[5] S. S. Morse, “Factors and determinants of disease emergence,” OIE Revue Scientific et Technique, vol. 23, no. 2, pp. 443–451, 2004.
[6] A. Tadin, R. Tokarz, A. Markotic et al., “Molecular survey of zoonotic agents in rodents and other small mammals in Croatia,” American Journal of Tropical Medicine and Hygiene, vol. 94, no. 2, pp. 466–473, 2016.
[7] World Health Organization, “Infections and infectious diseases: a manual for nurses and midwives in the WHO European Region,” http://www.euro.who.int/ data/assets/pdf file/0013/102316/e79822.pdf.
[8] S. S. Morse, J. A. K. Mazet, M. Woolhouse et al., “Prediction and prevention of the next pandemic zoonosis,” The Lancet, vol. 380, no. 9857, pp. 1956–1965, 2012.
[9] MATER METHODS 2013; 3:207
[10] van Elden L, Nijhuis M, Schipper P, Schuurman R, van Loon A. Simultaneous detection of influenza viruses A and B using real-time quantitative PCR. J Clin Microbiol. 2001; 39:196-200
[11] Corman V, Landt O, Kaiser M, Molenkamp R, Meijer A, Chu D, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25
[12] Abbott. (2020b). ID NOWTM is a leading molecular point-of-care platform in the United States, trusted by hospitals, physician offices, and urgent care clinics nationwide. https://www.alere.com/en/home/product-details/id-now-covid-19.html
[13] McLoughlin K. Microarrays for pathogen detection and analysis. Brief Funct Genomics. 2011; 10:342-53
[14] Jaing C, Gardner S, McLoughlin K, Thissen J, Slezak T. Detection of adventitious viruses from biologicals using a broad-spectrum microbial detection array. PDA J Pharm Sci Technol. 2011; 65:668-74
[15] Khanna M, Kumar P, Chugh L, Prasad A, Chhabra S. Evaluation of influenza virus detection by direct enzyme immunoassay (EIA) and conventional methods in asthmatic patients. J Commun Dis. 2001; 33:163-9
[16] Waner J, Todd S, Shalaby H, Murphy P, Wall L. Comparison of Directigen FLU-A with viral isolation and direct immunofluorescence for the rapid detection and identification of influenza A virus. J Clin Microbiol. 1991; 29:479-82
[17] Lee M, Cohen B, Hand J, Nokes D. A simplified and standardized neutralization enzyme immunoassay for the quantification of measles neutralizing antibody. J Virol Methods. 1999; 78:209-17
[18] Kim M, Kang S, Lee W. Evaluation of a new rapid test kit to detect hepatitis C virus infection. J Virol Methods. 2013; 193:379-82
[19] Niu X, Wang X, Liu G, Li Y. [Establishment of the evaluation reference system for domestic anti-hepatitis C virus diagnostic enzyme immunoassay kits]. Xi Bao Yu Fen Zi Mian Yi Xue Za Zhi. 2013; 29:761-4
[20] Filice G, Soldini L, Orsolini P, Razzini E, Gulminetti R, Campisi D, et al. Sensitivity and specificity of anti-HIV ELISA employing recombinant (p24, p66, gp120) and synthetic (gp41) viral antigenic peptides. Microbiologica. 1991; 14:185-94
[21] de Boer G, Back W, Osterhaus A. An ELISA for detection of antibodies against influenza A nucleoprotein in humans and various animal species. Arch Virol. 1990; 115:47-61
[22] Cuzzubbo A, Vaughn D, Nisalak A, Solomon T, Kalayanarooj S, Aaskov J, et al. Comparison of PanBio dengue duo enzyme-linked immunosorbent assay (ELISA) and MRL dengue fever virus immunoglobulin M capture ELISA for diagnosis of dengue virus infections in Southeast Asia. Clin Diagn Lab Immunol. 1999; 6:705-12
[23] https://www.virology.ws/2010/07/16/detection-of-antigens-or-antibodies-by-elisa/
[24] Zhang WJ, Lv X, Huang C, et al. Clinical evaluation and application of detection of IgM and IgG antibodies against
SARS-CoV-2 using a colloidal gold immunochromatography assay[J]. Chinese Journal of Virology, 2020, 36(3):348-354.
[25] Li H, Li YY, Zhang ZG, et al. Establishment and clinical performance evaluation of 2019 novel coronavirus antibody colloidal gold detection method[J]. Chinese Journal of Infectious Diseases, 2020, 38(3):139-144.
[26] Augustine R, Das S, Hasan A, S A, Abdul Salam S, Augustine P, Dalvi YB, Varghese R, Primavera R, Yassine HM, Thakor AS, Kevadiya BD. Rapid Antibody-Based COVID-19 Mass Surveillance: Relevance, Challenges, and Prospects in a Pandemic and Post-Pandemic World. J Clin Med. 2020 Oct 21;9(10):3372. doi: 10.3390/jcm9103372. PMID: 33096742; PMCID: PMC7589650.
[27] LI Jia-jun, ZHENG Xiao, et al. Novel Coronavirus and Research Progress of Related Clinical Detection Methods[J]. Biotechnology Bulletin, ISSN 1002-5464, CN 11-2396/Q.
[28] Timothy M Uyeki, Henry H Bernstein, et al. Clinical Practice Guidelines by the Infectious Diseases Society of America: 2018 Update on Diagnosis, Treatment, Chemoprophylaxis, and Institutional Outbreak Management of Seasonal Influenza, Clinical Infectious Diseases, Volume 68, Issue 6, 15 March 2019, Pages e1–e47, https://doi.org/10.1093/cid/ciy866
[29] Anestad G. Surveillance of respiratory viral infections by rapid immunofluorescence diagnosis, with emphasis on virus interference. Epidemiol Infect. 1987; 99:523-31
[30] Daisy J, Lief F, Friedman H. Rapid diagnosis of influenza A infection by direct immunofluorescence of nasopharyngeal aspirates in adults. J Clin Microbiol. 1979; 9:688-92
[31] Johnson J, Higgins A, Navarro A, HUANG Y, Esper F, Barton N, et al. Subtyping influenza A virus with monoclonal antibodies and an indirect immunofluorescence assay. J Clin Microbiol. 2012; 50:396-400
[32] Fauvel M, Ozanne G. Immunofluorescence assay for human immunodeficiency virus antibody: investigation of cell fixation for virus inactivation and antigen preservation. J Clin Microbiol. 1989; 27:1810-3
[33] Klespies S, Cebula D, Kelley C, Galehouse D, Maurer C. Detection of enteroviruses from clinical specimens by spin amplification shell vial culture and monoclonal antibody assay. J Clin Microbiol. 1996; 34:1465-7
[34] Coffin S, Hodinka R. Utility of direct immunofluorescence and virus culture for detection of varicella-zoster virus in skin lesions. J Clin Microbiol. 1995; 33:2792-5
[35] Caviness A, Oelze L, Saz U, Greer J, Demmler Harrison G. Direct immunofluorescence assay compared to cell culture for the diagnosis of mucocutaneous herpes simplex virus infections in children. J Clin Virol. 2010; 49:58-60
[36] Pouletty P, Chomel J, Thouvenot D, Catalan F, Rabillon V, Kadouche J. Detection of herpes simplex virus in direct specimens by immunofluorescence assay using a monoclonal antibody. J Clin Microbiol. 1987; 25:958-9
[37] Liu I, Chen P, Yeh S, Chiang Y, Huang L, Chang M, et al. Immunofluorescence assay for detection of the nucleocapsid antigen of the severe acute respiratory syndrome (SARS)-associated coronavirus in cells derived from throat wash samples of patients with SARS. J Clin Microbiol. 2005; 43:2444-8
[38] https://fineartamerica.com/featured/6-vaccinia-virus-infected-cell-dr-dan-kalman.html
[39] Schochetman G, Epstein J, Zuck T. Serodiagnosis of infection with the AIDS virus and other human retroviruses. Annu Rev Microbiol. 1989; 43:629-59
[40] Damen M, Zaaijer H, Cuypers H, Vrielink H, van der Poel C, Reesink H, et al. Reliability of the third-generation recombinant immunoblot assay for hepatitis C virus. Transfusion. 1995; 35:745-9
[41] Kong Q, Xue C, Ren X, Zhang C, Li L, Shu D, et al. Proteomic analysis of purified coronavirus infectious bronchitis virus particles. Proteome Sci. 2010; 8:29
[42] Ren X, Xue C, Kong Q, Zhang C, Bi Y, Cao Y. Proteomic analysis of purified Newcastle disease virus particles. Proteome Sci. 2012; 10:32
[43] Nagler F, Rake G. The Use of the Electron Microscope in Diagnosis of Variola, Vaccinia, and Varicella. J Bacteriol. 1948; 55:45-51
[44] Gust I, Kaldor J, Cross G, Waugh M, Ferris A. Virus-like particles associated with a faecal antigen from hepatitis patients and with Australia antigen. Aust J Exp Biol Med Sci. 1971; 49:1-9
[45] Kapikian A, Wyatt R, Dolin R, Thornhill T, Kalica A, Chanock R. Visualization by immune electron microscopy of a 27-nm particle associated with acute infectious nonbacterial gastroenteritis. J Virol. 1972; 10:1075-81
[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



GENEMEDI
6th Floor, Buiding No.2, Kangxin Road 3377, Shanghai, China
Email: [email protected] [email protected]
Telephone: +86-21-50478399   Fax: 86-21-50478399
Privacy Policy
Chinese Website

COVID-19
related
protocols,
data and
products

COVID-19 related protocols, data and products

×