Review of the Literature on Diagnostic Tests for COVID-19
Keywords:
COVID-19, SARS-CoV-2, diagnostic test
Abstract
The COVID-19 pandemic caused by the transmission of SARS-CoV-2 has generated a large health and socio-economic impact for which there are no current treatments or vaccines available. Therefore, SARS-CoV-2 transmission is being controlled through social distancing and surveillance by testing the population for the virus. Tests are useful to understand the transmission of the virus and to obtain data on the number of COVID-19 cases. The implementation of different tests influences clinical and public policy decision-making; thus, the objective of this article is to review the available evidence on diagnostic tests for SARS-CoV-2, including recommendations from clinical practice guidelines that have been developed during the pandemic
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References
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29. Cheng MP, Papenburg J, Desjardins M, Kanjilal S, Quach C, Libman M, Dittrich S, Yansouni CP. Diagnostic Testing for Severe Acute Respiratory Syndrome–Related Coronavirus-2: A Narrative Review. Annals of Internal Medicine. 2020 Apr 13.
30. Zou L, Ruan F, Huang M, et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients [Letter]. N Engl J Med. 2020; 382:1177-1179. [PMID: 32074444] doi:10.1056/NEJMc2001737
31. Guo L, Ren L, Yang S, et al. Profiling early humoral response to diagnose novel coronavirus disease (COVID-19). Clin Infect Dis. 2020. [PMID: 32198501] doi:10.1093/cid/ciaa310
32. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clinical Infectious Diseases. 2020 Jan 1.
33. Qu J, Wu C, Li X, Zhang G, Jiang Z, Li X, Liu L. Profile of IgG and IgM antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical Infectious Diseases. 2020 Apr 27.
34. Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nature Medicine. 2020 Apr 29:1-4.
35. Patrick DM, Petric M, Skowronski DM, et al. An outbreak of human coronavirus OC43 infection and serological cross-reactivity with SARS coronavirus. Can J Infect Dis Med Microbiol. 2006;17:330-6. [PMID: 18382647]
36. To KK, Tsang OT, Leung WS, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020. [PMID: 32213337] doi:10.1016 /S1473-3099(20)30196-1
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39. Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC). COVID-19. 2020.
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41. Zheng YY, Ma YT, Zhang JY, Xie X. Reply to:‘Interaction between RAAS inhibitors and ACE2 in the context of COVID-19’. Nature Reviews Cardiology. 2020 Mar 30:1-.
42. Udugama B, Kadhiresan P, Kozlowski HN, Malekjahani A, Osborne M, Li VY, Chen H, Mubareka S, Gubbay J, Chan WC. Diagnosing COVID-19: The Disease and Tools for Detection. ACS nano. 2020 Mar 30.
43. Döhla M, Boesecke C, Schulte B, Diegmann C, Sib E, Richter E, Eschbach-Bludau M, Aldabbagh S, Marx B, Eis-Hübinger AM, Schmithausen RM. Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity. Public Health. 2020 Apr 18.
44. Harrington A, Cox B, Snowdon J, Bakst J, Ley E, Grajales P, Maggiore J, Kahn S. Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. Journal of Clinical Microbiology. 2020 Apr 23.
45. Hope, M.D., Raptis, C.A., Shah, A., Hammer, M.M. and Henry, T.S., 2020. A role for CT in COVID-19? What data really tell us so far. The Lancet, 395(10231), pp.1189-1190.
46. Porte L, Legarraga P, Vollrath V, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis. 2020;99:328-333. doi:10.1016/j.ijid.2020.05.098.
47. Shen B, Zheng Y, Zhang X, et al. Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG. Am J Transl Res. 2020;12(4):1348-1354. Published 2020 Apr 15.
48. Dörschug A, Schwanbeck J, Hahn A, et al. Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold) [published online ahead of print, 2020 Sep 25]. Eur J Microbiol Immunol (Bp). 2020;10(3):178-185. doi:10.1556/1886.2020.00029
49. Lambert-Niclot S, Cuffel A, Le Pape S, et al. Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs. J Clin Microbiol. 2020;58(8):e00977-20. Published 2020 Jul 23. doi:10.1128/JCM.00977-20.
50. British Society of Thoracic Imaging. Thoracic imaging in COVID-19 infection: guidance for the reporting radiologist - version 2. 2020
51. Ai, T., Yang, Z., Hou, H., Zhan, C., Chen, C., Lv, W., Tao, Q., Sun, Z. and Xia, L., 2020. Correlation of chest CT and RT-PCR testing in coronavirus disease 2019 (COVID-19) in China: a report of 1014 cases. Radiology, p.200642.
52. Yang W, Cao Q, Qin L, et al. Clinical characteristics and imaging manifestations of the 2019 novel coronavirus disease (COVID-19): a multi-center study in Wenzhou city, Zhejiang, China. J Infect. 2020 Apr;80(4):388-93
53. American College of Radiology. ACR recommendations for the use of chest radiography and computed tomography (CT) for suspected COVID-19 infection. 2020 [internet publication.
54. Sun P, Qie S, Liu Z, et al. Clinical characteristics of 50466 hospitalized patients with 2019-nCoV infection. J Med Virol. 2020 Feb 28 [Epub ahead of print].
55. Diagnosis and clinical management of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection: an operational recommendation of Peking Union Medical College Hospital Inui, S., Fujikawa, A., Jitsu, M., Kunishima, N., Watanabe, S., Suzuki, Y., ... & Uwabe, Y. (2020). Chest CT findings in cases from the cruise ship “Diamond Princess” with coronavirus disease 2019 (COVID-19). Radiology: Cardiothoracic Imaging, 2(2), e200110.
56. Rubin GD, Haramati LB, Kanne JP, Schluger NW, Yim J-J, Anderson DJ, et al. The Role of Chest Imaging in Patient Management during the COVID-19 Pandemic: A Multinational Consensus Statement from the Fleischner Society. Radiology. 2020;In press.
2. World Health Organization (WHO). Coronavirus disease (COVID-19) pandemic. 2020.https://www.who.int/emergencies/diseases/novel-coronavirus-2019
3. Johns Hopkins University. COVID-19 Dashboard by the Center for systems Science and Engineering (CSSE) at Johns Hopkins University (JHU). 2020.https://coronavirus.jhu.edu/map.html.
4. Wilder-Smith A, Freedman DO. Isolation, quarantine, social distancing and community containment: pivotal role for old-style public health measures in the novel coronavirus (2019-nCoV) outbreak. J Travel Med. 2020;27(2).
5. Leeflang MMG, Deeks JJ, Gatsonis C, Bossuyt PMM. Systematic Reviews of Diagnostic Test Accuracy. Ann Intern Med [Internet]. 2008;149:889–98. Available from:https://www.acpjournals.org/doi/pdf/10.7326/0003-4819-149-12-200812160-00008
6. Organization. WH. Laboratory testing for coronavirus disease (COVID-19) in suspected human cases. World Heal Organ [Internet]. 2020 Mar; Available from: https://apps.who.int/iris/handle/10665/331329
7. Lippi G, Simundic A-M, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin Chem Lab Med [Internet]. 2020; Available from: https://www.degruyter.com/doi/10.1515/cclm-2020-0285
8. Pang J, Wang M., Ang IYH, Tan SH., Lewis R., Chen JI., et al. Potential Rapid Diagnostics, Vaccine and Therapeutics for 2019 Novel Coronavirus (2019-nCoV): A Systematic Review. J Clin Med. 2020;9(3):623.
9. Lippi G, Plebani M. The novel coronavirus (2019-nCoV) outbreak: think the unthinkable and be prepared to face the challenge. Diagnosis. 2020;0(0):8–10.
10. Yang Y, Yang M, Shen C, Wang F, Yuan J, Li J, et al. Evaluating the accuracy of different respiratory specimens in the laboratory diagnosis and monitoring the viral shedding of 2019-nCoV infections. medRxiv [Internet]. 2020;2020.02.11.20021493. Available from: http://medrxiv.org/content/early/2020/02/17/2020.02.11.20021493.abstract%0Ahttps://www.medrxiv.org/content/10.1101/2020.02.11.20021493v2
11. Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, et al. Clinical Characteristics of 138 Hospitalized Patients with 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA - J Am Med Assoc. 2020;323(11):1061–9.
12. Li Q, Guan X, Wu P, Wang X, Zhou L, Tong Y, et al. Early transmission dynamics in Wuhan, China, of novel coronavirus-infected pneumonia. N Engl J Med. 2020;382(13):1199–207.
13. Pan Y, Zhang D, Yang P, Poon LLM, Wang Q. Viral load of SARS-CoV-2 in clinical samples. Lancet Infect Dis. 2020;20(4):411-(4):411–2.
14. Kai-Wang To K, Tak-Yin Tsang O, Leung W-S, Raymond Tam A, Wu T-C, Lung DC, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis [Internet]. 2020;(January):19–21. Available from:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7158907/pdf/main.pdf
15. Arevalo-Rodriguez I, Buitrago-Garcia D, Simancas-Racines D, Zambrano-Achig P, Campo R del, Ciapponi A, et al. False-Negative Results of Initial Rt-Pcr Assays for Covid-19: a Systematic Review. medRxiv. 2020;2020.04.16.20066787
16. World Health Organization. Laboratory testing for coronavirus disease (COVID-19) in suspected human cases. World Heal Organ [Internet]. 2020 Mar 19; Available from: https://apps.who.int/iris/handle/10665/331329
17. Dasheng L, Wang D, Dong J, Wang N, Huang H, Xu H, et al. False-Negative Results of Real-Time Reverse-Transcriptase Polymerase Chain Reaction for Severe Acute Respiratory Syndrome Coronavirus 2: Role of Deep-Learning-Based CT Diagnosis and Insights from Two Cases. Korean J Radiol [Internet]. 2020;21(4):505–8. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7082661/pdf/kjr-21-505.pdf
18. World Health Organization. Advice on the use of point-of-care immunodiagnostic tests for COVID-19. 2020.https://www.who.int/news-room/commentaries/detail/advice-on-the-use-of-point-of-care-immunodiagnostic-tests-for-covid-19.
19. European Centre for Disease Prevention and Control. An overview of the rapid test situation for COVID-19 diagnosis in the EU/EEA. 1 April 2020. Stockholm: ECDC; 2020
20. Jin YH, Cai L, Cheng ZS, Cheng H, Deng T, Fan YP, et al. A rapid advice guideline for the diagnosis and treatment of 2019 novel coronavirus (2019-nCoV) infected pneumonia (standard version). Military Medical Research. 2020;7(1):4.
21. Asociación Colombiana de Infectología. Consenso Colombiano de Atención, Diagnóstico y Manejo de la Infección por SARS-CoV-2/ COVID-19 en establecimientos de atención de la salud. Infectio. 2020;24(3 (S1)):1-163.
22. Secretaria de Ciência Tecnologia Inovação e Insumos Estratégicos em Saúde (SCTIE). Diretrizes para Diagnóstico e Tratamento da COVID-19. Brasilia, Brazil: MINISTÉRIO DA SAÚDE. 2020.
23. Li T, Working Group of Novel Coronavirus Peking Union Medical College H. Diagnosis and clinical management of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection: an operational recommendation of Peking Union Medical College Hospital (V2.0). Emerging microbes & infections. 2020;9(1):582-5.
24. The First Affiliated Hospital-Zhejiang University School of Medicine. Handbook of COVID-19 Prevention and Treatment. China: Zhejiang University School of Medicine; 2020. Available from:https://covid-19.alibabacloud.com/.
25. Flisiak R, Horban A, Jaroszewicz J, Kozielewicz D, Pawłowska M, Parczewski M, et al. Recommendations of management in SARS-CoV-2 infection of the Polish Association of Epidemiologists and Infectiologists. Version 31-03-2020. Pol Arch Intern Med. 2020;In press.
26. World Health Organization. Laboratory testing for coronavirus disease (COVID-19) in suspected human cases. Interim guidance. Geneve, Switzerland: World Health Organization,; 2020
27. National Institute for Communicable Diseases Department. Clinical Management of Suspected or confirmed COVID-19 Disease. In: Department of Health, editor. V2 ed. South Africa: Republic of South Africa; 2020
28. Hong KH, LeeKim SW, Soo T, Lee J, Huh HJ, Kim SY, et al. Guidelines for Laboratory Diagnosis of Coronavirus Disease 2019 (COVID-19) in Korea. Annals of Laboratory Medice. 2020;40(5):351-60.
29. Cheng MP, Papenburg J, Desjardins M, Kanjilal S, Quach C, Libman M, Dittrich S, Yansouni CP. Diagnostic Testing for Severe Acute Respiratory Syndrome–Related Coronavirus-2: A Narrative Review. Annals of Internal Medicine. 2020 Apr 13.
30. Zou L, Ruan F, Huang M, et al. SARS-CoV-2 viral load in upper respiratory specimens of infected patients [Letter]. N Engl J Med. 2020; 382:1177-1179. [PMID: 32074444] doi:10.1056/NEJMc2001737
31. Guo L, Ren L, Yang S, et al. Profiling early humoral response to diagnose novel coronavirus disease (COVID-19). Clin Infect Dis. 2020. [PMID: 32198501] doi:10.1093/cid/ciaa310
32. Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clinical Infectious Diseases. 2020 Jan 1.
33. Qu J, Wu C, Li X, Zhang G, Jiang Z, Li X, Liu L. Profile of IgG and IgM antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Clinical Infectious Diseases. 2020 Apr 27.
34. Long QX, Liu BZ, Deng HJ, Wu GC, Deng K, Chen YK, Liao P, Qiu JF, Lin Y, Cai XF, Wang DQ. Antibody responses to SARS-CoV-2 in patients with COVID-19. Nature Medicine. 2020 Apr 29:1-4.
35. Patrick DM, Petric M, Skowronski DM, et al. An outbreak of human coronavirus OC43 infection and serological cross-reactivity with SARS coronavirus. Can J Infect Dis Med Microbiol. 2006;17:330-6. [PMID: 18382647]
36. To KK, Tsang OT, Leung WS, et al. Temporal profiles of viral load in posterior oropharyngeal saliva samples and serum antibody responses during infection by SARS-CoV-2: an observational cohort study. Lancet Infect Dis. 2020. [PMID: 32213337] doi:10.1016 /S1473-3099(20)30196-1
37. U.S. Food and Drug Administration (FDA) Accelerated Emergency use Authorization (EUA) Summary COVID-19 ELISA IGG Antibody Test (MOUNT SINAI LABORATORY). S.F. Disponible en:https://www.fda.gov/media/137029/download
38. Sociedad Española de Enfermedades Infecciosas y Microbiologia Clínica. Recomendaciones de SEIMC sobre el uso de las pruebas de detección de anticuerpos. 2020.
39. Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC). COVID-19. 2020.
40. Loeffelholz MJ, Tang YW. Laboratory diagnosis of emerging human coronavirus infections—the state of the art. Emerging microbes & infections. 2020 Mar 19(just-accepted):1-26.
41. Zheng YY, Ma YT, Zhang JY, Xie X. Reply to:‘Interaction between RAAS inhibitors and ACE2 in the context of COVID-19’. Nature Reviews Cardiology. 2020 Mar 30:1-.
42. Udugama B, Kadhiresan P, Kozlowski HN, Malekjahani A, Osborne M, Li VY, Chen H, Mubareka S, Gubbay J, Chan WC. Diagnosing COVID-19: The Disease and Tools for Detection. ACS nano. 2020 Mar 30.
43. Döhla M, Boesecke C, Schulte B, Diegmann C, Sib E, Richter E, Eschbach-Bludau M, Aldabbagh S, Marx B, Eis-Hübinger AM, Schmithausen RM. Rapid point-of-care testing for SARS-CoV-2 in a community screening setting shows low sensitivity. Public Health. 2020 Apr 18.
44. Harrington A, Cox B, Snowdon J, Bakst J, Ley E, Grajales P, Maggiore J, Kahn S. Comparison of Abbott ID Now and Abbott m2000 methods for the detection of SARS-CoV-2 from nasopharyngeal and nasal swabs from symptomatic patients. Journal of Clinical Microbiology. 2020 Apr 23.
45. Hope, M.D., Raptis, C.A., Shah, A., Hammer, M.M. and Henry, T.S., 2020. A role for CT in COVID-19? What data really tell us so far. The Lancet, 395(10231), pp.1189-1190.
46. Porte L, Legarraga P, Vollrath V, et al. Evaluation of a novel antigen-based rapid detection test for the diagnosis of SARS-CoV-2 in respiratory samples. Int J Infect Dis. 2020;99:328-333. doi:10.1016/j.ijid.2020.05.098.
47. Shen B, Zheng Y, Zhang X, et al. Clinical evaluation of a rapid colloidal gold immunochromatography assay for SARS-Cov-2 IgM/IgG. Am J Transl Res. 2020;12(4):1348-1354. Published 2020 Apr 15.
48. Dörschug A, Schwanbeck J, Hahn A, et al. Evaluation of the Xiamen AmonMed Biotechnology rapid diagnostic test COVID-19 IgM/IgG test kit (Colloidal gold) [published online ahead of print, 2020 Sep 25]. Eur J Microbiol Immunol (Bp). 2020;10(3):178-185. doi:10.1556/1886.2020.00029
49. Lambert-Niclot S, Cuffel A, Le Pape S, et al. Evaluation of a Rapid Diagnostic Assay for Detection of SARS-CoV-2 Antigen in Nasopharyngeal Swabs. J Clin Microbiol. 2020;58(8):e00977-20. Published 2020 Jul 23. doi:10.1128/JCM.00977-20.
50. British Society of Thoracic Imaging. Thoracic imaging in COVID-19 infection: guidance for the reporting radiologist - version 2. 2020
51. Ai, T., Yang, Z., Hou, H., Zhan, C., Chen, C., Lv, W., Tao, Q., Sun, Z. and Xia, L., 2020. Correlation of chest CT and RT-PCR testing in coronavirus disease 2019 (COVID-19) in China: a report of 1014 cases. Radiology, p.200642.
52. Yang W, Cao Q, Qin L, et al. Clinical characteristics and imaging manifestations of the 2019 novel coronavirus disease (COVID-19): a multi-center study in Wenzhou city, Zhejiang, China. J Infect. 2020 Apr;80(4):388-93
53. American College of Radiology. ACR recommendations for the use of chest radiography and computed tomography (CT) for suspected COVID-19 infection. 2020 [internet publication.
54. Sun P, Qie S, Liu Z, et al. Clinical characteristics of 50466 hospitalized patients with 2019-nCoV infection. J Med Virol. 2020 Feb 28 [Epub ahead of print].
55. Diagnosis and clinical management of severe acute respiratory syndrome Coronavirus 2 (SARS-CoV-2) infection: an operational recommendation of Peking Union Medical College Hospital Inui, S., Fujikawa, A., Jitsu, M., Kunishima, N., Watanabe, S., Suzuki, Y., ... & Uwabe, Y. (2020). Chest CT findings in cases from the cruise ship “Diamond Princess” with coronavirus disease 2019 (COVID-19). Radiology: Cardiothoracic Imaging, 2(2), e200110.
56. Rubin GD, Haramati LB, Kanne JP, Schluger NW, Yim J-J, Anderson DJ, et al. The Role of Chest Imaging in Patient Management during the COVID-19 Pandemic: A Multinational Consensus Statement from the Fleischner Society. Radiology. 2020;In press.
Published
2020-11-26
How to Cite
1.
Zambrano-Achig P, Montesinos-Guevara C, Guerra V, Hidalgo-Ottolenghi R, Simancas-Racines D. Review of the Literature on Diagnostic Tests for COVID-19. PFR [Internet]. 2020Nov.26 [cited 2025Apr.1];5(3). Available from: https://practicafamiliarrural.org/index.php/pfr/article/view/177
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