Laboratory Detection of SARS-CoV-2: Dilemma of Choosing the Best Test
,
Abstract
The new coronavirus disease (COVID-19) pandemic is a global health problem that appeared in late 2019 through severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). This perplexing virus has a high infection rate, and with no specific treatment, the mortality and morbidity rates are rapidly increasing. Moreover, the new virus variant, which is more contagious and has a higher mortality rate than previous variants, has been detected in the United Kingdom. There are few vaccines at clinical stages. However, the distancing, track, and trace will stay with us for at least the next few years. Hence, detecting symptomatic and asymptomatic patients through accurate detective tests such as molecular and serological assays and quarantine is the only preventive method that can be used for controlling the pandemic. It is essential to use highly accurate tests to decrease the number of false negative and false positive results. This research aimed to highlight and critically assess the specificity and sensitivity of coronavirus tests available for detecting the SARS-CoV-2 virus. Currently, this is a multibillion-dollar industry, and many tests enter the clinical setting without having fully been validated.
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2. Riou JAlthaus CL. Pattern of early human-to-human transmission of Wuhan 2019 novel coronavirus (2019-nCoV), December 2019 to January 2020. Eurosurveillance. 2020;25(4).
3. Parry J. China coronavirus: cases surge as official admits human to human transmission. British Medical Journal Publishing Group; 2020.
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7. de Wit E, van Doremalen N, Falzarano DMunster VJ. SARS and MERS: recent insights into emerging coronaviruses. Nature Reviews Microbiology. 2016;14(8):523.
8. Simmons G, Reeves JD, Rennekamp AJ, Amberg SM, Piefer AJBates P. Characterization of severe acute respiratory syndrome-associated coronavirus (SARS-CoV) spike glycoprotein-mediated viral entry. Proceedings of the National Academy of Sciences. 2004;101(12):4240-45.
9. Belouzard S, Chu VCWhittaker GR. Activation of the SARS coronavirus spike protein via sequential proteolytic cleavage at two distinct sites. Proceedings of the National Academy of Sciences. 2009;106(14):5871-76.
10. Wang H, Yang P, Liu K, Guo F, Zhang Y, Zhang G, et al. SARS coronavirus entry into host cells through a novel clathrin-and caveolae-independent endocytic pathway. Cell research. 2008;18(2):290-301.
11. Kuba K, Imai Y, Ohto-Nakanishi TPenninger JM. Trilogy of ACE2: A peptidase in the renin–angiotensin system, a SARS receptor, and a partner for amino acid transporters. Pharmacology & therapeutics. 2010;128(1):119-28.
12. Shang J, Wan Y, Luo C, Ye G, Geng Q, Auerbach A, et al. Cell entry mechanisms of SARS-CoV-2. Proceedings of the National Academy of Sciences. 2020:202003138.
13. Bastola A, Sah R, Rodriguez-Morales AJ, Lal BK, Jha R, Ojha HC, et al. The first 2019 novel coronavirus case in Nepal. The Lancet Infectious Diseases. 2020;20(3):279-80.
14. Shen K, Yang Y, Wang T, Zhao D, Jiang Y, Jin R, et al. Diagnosis, treatment, and prevention of 2019 novel coronavirus infection in children: experts’ consensus statement. World Journal of Pediatrics. 2020:1-9.
15. Pan Y, Zhang D, Yang P, Poon LLWang Q. Viral load of SARS-CoV-2 in clinical samples. The Lancet Infectious Diseases. 2020;20(4):411-12.
16. Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. New England Journal of Medicine. 2020;382(12):1177-79.
17. Loeffelholz MJTang Y-W. Laboratory Diagnosis of Emerging Human Coronavirus Infections—The State of the Art. Emerging Microbes & Infections. 2020(just-accepted):1-26.
18. Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020.
19. Druce J, Garcia K, Tran T, Papadakis GBirch C. Evaluation of swabs, transport media, and specimen transport conditions for optimal detection of viruses by PCR. Journal of clinical microbiology. 2012;50(3):1064-65.
20. Chan JF-W, Yip CC-Y, To KK-W, Tang TH-C, Wong SC-Y, Leung K-H, et al. Improved molecular diagnosis of COVID-19 by the novel, highly sensitive and specific COVID-19-RdRp/Hel real-time reverse transcription-polymerase chain reaction assay validated in vitro and with clinical specimens. Journal of Clinical Microbiology. 2020.
21. Li J-PO, Lam DSC, Chen YTing DSW. Novel Coronavirus disease 2019 (COVID-19): The importance of recognising possible early ocular manifestation and using protective eyewear. BMJ Publishing Group Ltd; 2020.
22. Xia J, Tong J, Liu M, Shen YGuo D. Evaluation of coronavirus in tears and conjunctival secretions of patients with SARS‐CoV‐2 infection. Journal of medical virology. 2020.
23. Goff J, Rowe A, Brownstein JSChunara R. Surveillance of acute respiratory infections using community-submitted symptoms and specimens for molecular diagnostic testing. PLoS currents. 2015;7.
24. To KK-W, Tsang OT-Y, Yip CC-Y, Chan K-H, Wu T-C, Chan JM-C, et al. Consistent detection of 2019 novel coronavirus in saliva. Clinical Infectious Diseases. 2020.
25. Rutgers. New Rutgers Saliva Test for Coronavirus Gets FDA Approval 2020 April 13 [Available from: https://www.rutgers.edu/news/new-rutgers-saliva-test-coronavirus-gets-fda-approval.
26. Zhang W, Du R-H, Li B, Zheng X-S, Yang X-L, Hu B, et al. Molecular and serological investigation of 2019-nCoV infected patients: implication of multiple shedding routes. Emerging microbes & infections. 2020;9(1):386-89.
27. Wu Y, Guo C, Tang L, Hong Z, Zhou J, Dong X, et al. Prolonged presence of SARS-CoV-2 viral RNA in faecal samples. The Lancet Gastroenterology & Hepatology. 2020.
28. Ontario PH. Coronavirus Disease 2019 (COVID-19) Testing 2020 March 16 [Available from: https://www.publichealthontario.ca/fr/laboratory-services/test-information-index/wuhan-novel-coronavirus.
29. Organization WH. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases: interim guidance, 2 March 2020. World Health Organization; 2020.
30. Bachman J. Reverse-transcription PCR (rt-PCR). Methods in enzymology. 530: Elsevier; 2013. p. 67-74.
31. Rothe C, Schunk M, Sothmann P, Bretzel G, Froeschl G, Wallrauch C, et al. Transmission of 2019-nCoV infection from an asymptomatic contact in Germany. New England Journal of Medicine. 2020;382(10):970-71.
32. Holshue ML, DeBolt C, Lindquist S, Lofy KH, Wiesman J, Bruce H, et al. First case of 2019 novel coronavirus in the United States. New England Journal of Medicine. 2020.
33. Finddx. SARS-COV-2 DIAGNOSTIC PIPELINE. 2020.
34. Freeman WM, Walker SJVrana KE. Quantitative RT-PCR: pitfalls and potential. Biotechniques. 1999;26(1):112-25.
35. Pan F, Ye T, Sun P, Gui S, Liang B, Li L, et al. Time course of lung changes on chest CT during recovery from 2019 novel coronavirus (COVID-19) pneumonia. Radiology. 2020:200370.
36. Lan L, Xu D, Ye G, Xia C, Wang S, Li Y, et al. Positive RT-PCR test results in patients recovered from COVID-19. Jama. 2020.
37. ABBOTT. ABBOTT LAUNCHES MOLECULAR POINT-OF-CARE TEST TO DETECT NOVEL CORONAVIRUS IN AS LITTLE AS FIVE MINUTES 2020 March 27 [Available from: https://abbott.mediaroom.com/2020-03-27-Abbott-Launches-Molecular-Point-of-Care-Test-to-Detect-Novel-Coronavirus-in-as-Little-as-Five-Minutes.
38. Bilgin DD, DeLucia EHClough SJ. A robust plant RNA isolation method suitable for Affymetrix GeneChip analysis and quantitative real-time RT-PCR. Nature protocols. 2009;4(3):333.
39. McDonald JS, Milosevic D, Reddi HV, Grebe SKAlgeciras-Schimnich A. Analysis of circulating microRNA: preanalytical and analytical challenges. Clinical chemistry. 2011;57(6):833-40.
40. Roberts TC, Hart JR, Kaikkonen MU, Weinberg MS, Vogt PKMorris KV. Quantification of nascent transcription by bromouridine immunocapture nuclear run-on RT-qPCR. Nature protocols. 2015;10(8):1198.
41. Raso A, Mascelli S, Nozza P, Ugolotti E, Vanni I, Capra V, et al. Troubleshooting fine‐tuning procedures for qPCR system design. Journal of clinical laboratory analysis. 2011;25(6):389-94.
42. Chu DK, Pan Y, Cheng SM, Hui KP, Krishnan P, Liu Y, et al. Molecular diagnosis of a novel coronavirus (2019-nCoV) causing an outbreak of pneumonia. Clinical chemistry. 2020;66(4):549-55.
43. Chan PK, To W-K, Ng K-C, Lam RK, Ng T-K, Chan RC, et al. Laboratory diagnosis of SARS. Emerging infectious diseases. 2004;10(5):825.
44. Zhang F, Abudayyeh OOJonathan SG. A protocol for detection of COVID-19 using CRISPR diagnostics. Broad Instute.
45. Ai J-W, Zhang Y, Zhang H-C, Xu TZhang W-H. Era of molecular diagnosis for pathogen identification of unexplained pneumonia, lessons to be learned. Emerging Microbes & Infections. 2020;9(1):597-600.
46. El-Tholoth M, Bau HHSong J. A Single and Two-Stage, Closed-Tube, Molecular Test for the 2019 Novel Coronavirus (COVID-19) at Home, Clinic, and Points of Entry. 2020.
47. CONVERSATION T. Coronavirus tests are pretty accurate, but far from perfect 2020 [Available from: https://theconversation.com/coronavirus-tests-are-pretty-accurate-but-far-from-perfect-136671.
48. Kannan S, ALI PSS, Sheeza AHemalatha K. COVID-19 (Novel Coronavirus 2019)–recent trends. European Review for Medical and Pharmacological Sciences. 2020;24:2006-11.
49. Li W, Liu L, Chen LShang S. Evaluation of a Commercial Colloidal Gold Assay for Detection of Influenza A and B Virus in Children’s Respiratory Specimens. Fetal and pediatric pathology. 2019:1-6.
50. Cai X, Chen J, Hu J, Long Q, Deng H, Fan K, et al. A Peptide-based Magnetic Chemiluminescence Enzyme Immunoassay for Serological Diagnosis of Corona Virus Disease 2019 (COVID-19). medRxiv. 2020.
51. Xiang J, Yan M, Li H, Liu T, Lin C, Huang S, et al. Evaluation of Enzyme-Linked Immunoassay and Colloidal Gold-Immunochromatographic Assay Kit for Detection of Novel Coronavirus (SARS-Cov-2) Causing an Outbreak of Pneumonia (COVID-19). medRxiv. 2020.
52. Zhang P, Gao Q, Wang T, Ke Y, Mo F, Jia R, et al. Evaluation of recombinant nucleocapsid and spike proteins for serological diagnosis of novel coronavirus disease 2019 (COVID-19). MedRxiv. 2020.
53. Cavalli G, De Luca G, Campochiaro C, Della-Torre E, Ripa M, Canetti D, et al. Interleukin-1 blockade with high-dose anakinra in patients with COVID-19, acute respiratory distress syndrome, and hyperinflammation: a retrospective cohort study. The Lancet Rheumatology. 2020.
54. Reagent B. COVID-19 Rapid Test CE Marking 2020 [Available from: https://www.biopanda.co.uk/php/products/rapid/infectious_diseases/covid19.php.
55. Zhou P, Yang X-L, Wang X-G, Hu B, Zhang L, Zhang W, et al. Discovery of a novel coronavirus associated with the recent pneumonia outbreak in humans and its potential bat origin. BioRxiv. 2020.
56. Post SCM. Coronavirus: low antibody levels raise questions about reinfection risk 2020 Apr 7 [Available from: https://www.scmp.com/news/china/science/article/3078840/coronavirus-low-antibody-levels-raise-questions-about.
57. Kandeil A, Gomaa M, Shehata M, El-Taweel A, Kayed AE, Abiadh A, et al. Middle East respiratory syndrome coronavirus infection in non-camelid domestic mammals. Emerging microbes & infections. 2019;8(1):103-08.
58. Zeng Z, Chen L, Pan Y, Deng Q, Ye G, Li Y, et al. Re: Profile of Specific Antibodies to SARS-CoV-2: The First Report. Journal of Infection. 2020.
59. Amanat F, Nguyen T, Chromikova V, Strohmeier S, Stadlbauer D, Javier A, et al. A serological assay to detect SARS-CoV-2 seroconversion in humans. medRxiv. 2020.
60. Cascella M, Rajnik M, Cuomo A, Dulebohn SCDi Napoli R. Features, evaluation and treatment coronavirus (COVID-19). StatPearls [Internet]: StatPearls Publishing; 2020.
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| Files | ||
| Issue | Vol 7, No 3 (2024) | |
| Section | Review Article | |
| DOI | https://doi.org/10.18502/igj.v7i3.17882 | |
| Keywords | ||
| COVID-19 SARS-CoV-2 Laboratory Tests Molecular Assays Serological Assays Vaccine Pandemic | ||
| Rights and permissions | |
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This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License. |
How to Cite
1.
Lotfi M, M. Seifalian A. Laboratory Detection of SARS-CoV-2: Dilemma of Choosing the Best Test. Immunol Genet J. 2024;7(3):150-165.
