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Covid-19; SARS-CoV-2; Immunoglobulins; Viral RNA.
During the last month of 2019, a new Coronavirus from China started to spread all around the world causing a pandemic emergency still ongoing. The outbreak made imperative the need for diagnostic and screening tests that could identify the current and past infection state of an individual. Occupational medicine is facing a very demanding challenge, as the pandemic set off the need to re-evaluate many aspects of workplace safety. A fundamental role has been played by tests used to diagnose COVID-19 and to isolate infected asymptomatic subjects, with a view to the viral evolution and the emerging variants. However, the need for the urgent set-up of new methods for assessing both new and past infections has resulted in a large number of methods, not always comparable with each other, in terms of laboratory techniques, viral antigens used for detection, and class of antibodies detected. These factors make it difficult to understand the serological test results and their possible application. In this paper, we reviewed the types of assays currently available, to address some key aspects that characterize each technique, and might have an impact on results interpretation.
2. Società Italiana di Medicina del Lavoro. Esami di laboratorio per SARS-CoV-2 nella gestione in ambito occupazionale della pandemia COVID 19. Posizione della Società Italiana di Medicina del Lavoro. MedLav. 2020; 111(2): 151-154.
3. Mutti A. Occupational Medicine in the time of COVID-19. Med Lav. 2020; 111(2): 83-86.
4. AIE. Test nasofaringeo “antigenico” rapido per il controllo della epidemia: considerazioni, possibili ambiti di applicazione e proposta operativa di gestione. From Test-nasofaringeo-antigenico-rapido-per-il-controllo-della-epidemia_AIE-1.
5. Mina MJ, Parker R, Larremore DB. Rethinking Covid-19 Test Sensitivity - A Strategy for Containment. N Engl J Med. 2020; 383(22): e120.
6. Raffle AE, Pollock AM, Harding-Edgar L. Covid-19 mass testing programmes. BMJ. 2020; 370: m3262.
7. Malik YA. Properties of Coronavirus and SARS-CoV-2. Malays J Pathol. 2020; 42(1): 3-11.
8. Naqvi AAT, Fatima K, Mohammad T, et al. Insights into SARS-CoV-2 genome, structure, evolution, pathogenesis and therapies: Structural genomics approach. Biochim Biophys Acta Mol Basis Dis. 2020; 1866(10): 165878.
9. Wang MY, Zhao R, Gao LJ, Gao XF, Wang DP, Cao JM. SARS-CoV-2: Structure, Biology, and Structure-Based Therapeutics Development. Front Cell Infect Microbiol. 2020; 10: 587269.
10. Walls AC, Park YJ, Tortorici MA, Wall A, McGuire AT, Veesler D. Structure, Function, and Antigenicity of the SARS-CoV-2 Spike Glycoprotein. Cell. 2020; 181(2): 281-292 e286.
11. Wrapp D, Wang N, Corbett KS, et al. Cryo-EM structure of the 2019-nCoV spike in the prefusion conformation. Science. 2020; 367(6483): 1260-1263.
12. FIND. (2021) SARS-CoV-2 diagnostic pipeline. Available on line at: http://www.finddx.org/covid-19/pipeline/ (last accessed 17-05-2021).
13. Butler-Laporte G, Lawandi A, Schiller I, et al. Comparison of Saliva and Nasopharyngeal Swab Nucleic Acid Amplification Testing for Detection of SARS-CoV-2: A Systematic Review and Meta-analysis."JAMA Intern Med. 2021; 181(3): 353-360.
14. CDC, Centers for Disease Control and Prevention. (2020) Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-19). Available on line at: https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html (last accessed 17-05-2021).
15. Vogels CBF, Brito AF, Wyllie AL, et al. Analytical sensitivity and efficiency comparisons of SARS-CoV-2 RT-qPCR primer-probe sets."Nat Microbiol. 2020; 5(10): 1299-1305.
16. Antonelli G, Stefani S, Pistello M. SARS-CoV-2 diagnostics: Some reflections on current assays." Diagn Microbiol Infect Dis. 2021; 99(2): 115237.
17. Corman VM, Landt O, Kaiser M, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020; 25(3).
18. ECDC, European Centre for Disease Prevention and Control (2020) Guidance for discharge and ending isolation in the context of widespread community transmission of COVID-19, 8 April 2020. Available on line at: https://www.ecdc.europa.eu/en/publications-data/covid-19-guidance-discharge-and-ending-isolation (last accessed 17-05-2021).
19. Woodruff A. COVID-19 follow up testing. J Infect. 2020.
20. Bullard J, Dust K, Funk D, et al. May 2020. Predicting infectious SARS-CoV-2 from diagnostic samples. Clin Infect Dis doi. 10.
21. Liu W-D, Chang S-Y, Wang J-T, et al. Prolonged virus shedding even after seroconversion in a patient with COVID-19." J Infect. 2020.
22. Public Health England. available online at https://www.gov.uk/government/publications/covid-19-management-of-exposed-healthcare-workers-and-patients-in-hospital-settings/covid-19-management-of-exposed-healthcare-workers-and-patients-in-hospital-settings#contact-risk-assessment-and-exemption-criteria
23. Azzi L, Baj A, Alberio T, et al. Rapid Salivary Test suitable for a mass screening program to detect SARS-CoV-2: A diagnostic accuracy study. J Infect. 2020; 81(3): e75-e78.
24. Dinnes J, Deeks JJ, Adriano A, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2020; 8: CD013705.
25. Torres I, Poujois S, Albert E, Alvarez G, Colomina J, Navarro D. Point-of-care evaluation of a rapid antigen test (CLINITEST(R) Rapid COVID-19 Antigen Test) for diagnosis of SARS-CoV-2 infection in symptomatic and asymptomatic individuals. J Infect. 2021.
26. Kohmer N, Toptan T, Pallas C, et al. The Comparative Clinical Performance of Four SARS-CoV-2 Rapid Antigen Tests and Their Correlation to Infectivity In Vitro. J Clin Med. 2021; 10(2).
27. Peeling RW, Olliaro PL, Boeras DI Fongwen N. Scaling up COVID-19 rapid antigen tests: promises and challenges. Lancet Infect Dis. 2021.
28. Corman VM, Haage VC, Bleicker T, Schmidt ML, Muhlemann B, Zuchowski M, Jo WK, Tscheak P, Moncke-Buchner E, Muller MA, Krumbholz A, Drexler JF and Drosten C "Comparison of seven commercial SARS-CoV-2 rapid point-of-care antigen tests: a single-centre laboratory evaluation study." Lancet Microbe. 2021.
29. Dinnes J, Deeks JJ, Berhane S, et al. Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection. Cochrane Database Syst Rev. 2021; 3: CD013705.
30. Long QX, Liu BZ, Deng HJ, et al. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nat Med. 2020; 26(6): 845-+.
31. Milani GP, Dioni L, Favero C, et al. Serological follow-up of SARS-CoV-2 asymptomatic subjects. Sci Rep. 2020; 10(1): 20048.
32. Okba NMA, Muller MA, Li W, Wang et al. Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease Patients. Emerg Infect Dis. 2020; 26(7): 1478-1488.
33. Roltgen K, Powell AE, Wirz OF, et al. Defining the features and duration of antibody responses to SARS-CoV-2 infection associated with disease severity and outcome. Sci Immunol. 2020; 5(54).
34. GeurtsvanKessel CH, Okba NMA, Igloi Z, et al. An evaluation of COVID-19 serological assays informs future diagnostics and exposure assessment. Nature Communications. 2020; 11(1): 3436.
35. Hodgson SH, Mansatta K, Mallett G, Harris V, Emary KRW, Pollard AJ. What defines an efficacious COVID-19 vaccine? A review of the challenges assessing the clinical efficacy of vaccines against SARS-CoV-2. Lancet Infectious Diseases. 2021; 21(2): e26-e35.
36. Watson J, Whiting PF, Brush JE. Interpreting a covid-19 test result. BMJ. 2020; 369: m1808.
37. Brownstein NC, Chen YA. Predictive values, uncertainty, and interpretation of serology tests for the novel coronavirus. Sci Rep. 2021; 11(1): 5491.
38. Zhang ZL, Hou YL, Li DT, Li FZ. Diagnostic efficacy of anti-SARS-CoV-2 IgG/IgM test for COVID-19: A meta-analysis. J Med Virol. 2021; 93(1): 366-374.
39. Sekine T, Perez-Potti A, Rivera-Ballesteros O, et al. Robust T Cell Immunity in Convalescent Individuals with Asymptomatic or Mild COVID-19. Cell. 2020; 183(1): 158-168 e114.
40. Marra MA, Jones SJ, Astell CR, et al. The Genome sequence of the SARS-associated coronavirus."Science. 2003; 300(5624): 1399-1404.
41. Dutta NK, Mazumdar K, Gordy JT. The Nucleocapsid Protein of SARS–CoV-2: a Target for Vaccine Development. Journal of Virology. 2020; 94(13): e00647-00620.
42. Ruan YJ, Wei CL, Ee AL, et al. Comparative full-length genome sequence analysis of 14 SARS coronavirus isolates and common mutations associated with putative origins of infection. Lancet. 2003; 361(9371): 1779-1785.
43. CDC, Centers for Disease Control and Prevention. (2021) Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Authorized in the United States. Available on line at: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html (last accessed 17-05-2021).
44. Arif TB. The 501.V2 and B.1.1.7 variants of coronavirus disease 2019 (COVID-19): A new time-bomb in the making? Infect Control Hosp Epidemiol. 2021: 1-2.
45. Tegally H, Wilkinson E, Giovanetti M, et al. Emergence and rapid spread of a new severe acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) lineage with multiple spike mutations in South Africa. medRxiv. 2020: 2020.2012.2021.20248640.
46. Maggi F, Novazzi F, Genoni A, et al. Imported SARS-COV-2 Variant P.1 Detected in Traveler Returning from Brazil to Italy. Emerg Infect Dis. 2021; 27(4).
47. CDC, Centers for Disease Control and Prevention. (2021) SARS-CoV-2 Variant Classifications and Definitions Available on line at: https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html (last accessed 17-05-2021).
48. Yadav PD, Sapkal GN, Abraham P, et al. Neutralization of variant under investigation B.1.617 with sera of BBV152 vaccinees. Clinical Infectious Diseases, 2021.
49. Gand M, Vanneste K, Thomas I, Van Gucht S, Capron A, Herman P, Roosens NHC, De Keersmaecker SCJ. Deepening of In Silico Evaluation of SARS-CoV-2 Detection RT-qPCR Assays in the Context of New Variants. Genes. 2021; 12(4):565.
50. Ramirez JD, Munoz M, Patino LH, Ballesteros N, Paniz-Mondolfi A. Will the emergent SARS-CoV2 B.1.1.7 lineage affect molecular diagnosis of COVID-19? J Med Virol. 2021.
51. Singh J, Samal J, Kumar V, et al. Structure-Function Analyses of New SARS-CoV-2 Variants B.1.1.7, B.1.351 and B.22.214.171.124: Clinical, Diagnostic, Therapeutic and Public Health Implications. Viruses. 2021; 13(3):439
52. Pickering S, Batra R, Snell LB, et al. Comparative performance of SARS CoV-2 lateral flow antigen tests demonstrates their utility for high sensitivity detection of infectious virus in clinical specimens. medRxiv. 2021: 2021.2002.2027.21252427.
53. Akingba OL, Sprong K, Hardie DR. Field performance evaluation of the PanBio rapid SARS-CoV-2 antigen assay in an epidemic driven by 501Y.v2 (lineage B.1.351) in the Eastern Cape, South Africa. medRxiv. 2021: 2021.2002.2003.21251057.
54. Gunther T, Czech-Sioli M, Indenbirken D, et al. SARS-CoV-2 outbreak investigation in a German meat processing plant. EMBO Mol Med. 2020; 12(12): e13296.
55. Gross JV, Fritschi L, Mohren J, Wild U, Erren TC. Contribution of Occupational Health to multidisciplinary team work for COVID-19 prevention and management. Med Lav. 2021; 112(2): 171-176.
56. Woloshin S, Patel N, Kesselheim AS. False Negative Tests for SARS-CoV-2 Infection - Challenges and Implications. N Engl J Med. 2020; 383(6): e38.