Current laboratory diagnostics of coronavirus disease 2019 (COVID-19)

Current laboratory diagnostics of coronavirus disease 2019 (COVID-19)

Authors

  • Giuseppe Lippi Section of Clinical Biochemistry, University of Verona, Verona, Italy
  • Camilla Mattiuzzi Service of Clinical Governance, Provincial Agency for Social and Sanitary Services, Trento, Italy
  • Chiara Bovo Medical Direction, University Hospital of Verona, Verona, Italy
  • Mario Plebani Department of Laboratory Medicine, University Hospital of Padova, Padova, Italy

Keywords:

Coronavirus, COVID-19, laboratory medicine, laboratory tests

Abstract

Laboratory medicine provides an almost irreplaceable contribution to the diagnostic reasoning and managed care of most human pathologies. The novel coronavirus disease 2019 (COVID-19) is not an exception to this paradigm. Although the relatively recent emergence does not allow to draw definitive conclusions on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostics, some standpoints can be conveyed. First and foremost, it seems now clear that we will be living together with this virus for quite a long time, so that our vigilance and responsiveness against the emergence of new local outbreaks shall be maintained at the highest possible levels. The etiological diagnosis of COVID-19 is, and will remain for the foreseeable future, deeply based on direct identification of viral RNA by means of molecular biology techniques in biological materials, especially upper and lower respiratory tract specimens. Whether other materials, such as blood, urine, stools, saliva and throat washing, will become valid alternatives has not been unequivocally defined so far. As concerns serological testing, promising information can be garnered from preliminary investigations, showing that the vast majority of COVID-19 patients seem to develop a sustained immune response against the virus, characterized especially by emergence of anti-SARS-CoV-2 IgG and IgA, 1 to 2 weeks after the onset of fever and/or respiratory symptoms. Whether these antibodies will have persistent neutralizing activity against the virus is still to be elucidated on individual and general basis. The availability of rapid tests for detecting either viral antigens or anti-SARS-CoV-2 antibodies are a potentially viable opportunity for purposes of epidemiologic surveillance, though more information is needed on accuracy and reliability of these portable immunoassays.

References

Lippi G, Sanchis-Gomar F, Henry BM. Coronavirus disease 2019 (COVID-19): the portrait of a perfect storm. Ann Transl Med 2020. doi: 10.21037/atm.2020.03.15.

Cucinotta D, Vanelli M. WHO Declares COVID-19 a Pandemic. Acta Biomed. 2020;91:157-160.

Lippi G, Henry BM, Bovo C, et al. Health risks and potential remedies during prolonged lockdowns for coronavirus disease 2019 (COVID-19). Diagnosis (Berl) 2020. Doi: 10.1515/dx-2020-0041.

Ceraolo C, Giorgi FM. Genomic variance of the 2019-nCoV coronavirus. J Med Virol 2020;92:522-528

GenBank. Severe acute respiratory syndrome coronavirus 2 isolate Wuhan-Hu-1, complete genome. https://www.ncbi.nlm.nih.gov/nuccore/NC_045512. Last accessed, April 15.

Cagliani R, Forni D, Clerici M, et al. Computational inference of selection underlying the evolution of the novel coronavirus, SARS-CoV-2. J Virol. 2020 Apr 1. pii: JVI.00411-20. doi: 10.1128/JVI.00411-20. (Epub ahead of print), 2020.

Wang Q, Zhang Y, Wu L, et al. Structural and Functional Basis of SARS-CoV-2 Entry by Using Human ACE2. Cell. 2020 Apr 7. doi: 10.1016/j.cell.2020.03.045. (Epub ahead of print).

Xu H, Zhong L, Deng J, et al. High expression of ACE2 receptor of 2019-nCoV on the epithelial cells of oral mucosa. Int J Oral Sci 2020;12:8.

Zou X, Chen K, Zou J, et al. Single-cell RNA-seq data analysis on the receptor ACE2 expression reveals the potential risk of different human organs vulnerable to 2019-nCoV infection. Front Med. 2020 Mar 12. doi: 10.1007/s11684-020-0754-0. (Epub ahead of print).

Hoffmann M, Kleine-Weber H, Schroeder S, et al. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Mar 4. doi: 10.1016/j.cell.2020.02.052. (Epub ahead of print).

Lai CC, Shih TP, Ko WC, et al. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and coronavirus disease-2019 (COVID-19): The epidemic and the challenges. Int J Antimicrob Agents. 2020 Feb 17:105924. doi: 10.1016/j.ijantimicag.2020.105924. (Epub ahead of print).

Lippi G, Mattiuzzi C, Sanchis-Gomar F, et al. Clinical and demographic characteristics of patients dying from COVID-19 in Italy versus China. J Med Virol. 2020 Apr 10. doi: 10.1002/jmv.25860. [Epub ahead of print].

Xu Z, Shi L, Wang Y, et al. Pathological findings of COVID-9 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Feb 18. pii: S2213-2600(20)30076-X. doi: 10.1016/S2213-2600(20)30076-X. (Epub ahead of print).

Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Feb 24. doi: 10.1001/jama.2020.2648. (Epub ahead of print).

Onder G, Rezza G, Brusaferro S. Case-Fatality Rate and Characteristics of Patients Dying in Relation to COVID-19 in Italy. JAMA. 2020 Mar 23. doi: 10.1001/jama.2020.4683. (Epub ahead of print).

Hussain M, Jabeen N, Raza F, et al. Structural Variations in Human ACE2 may Influence its Binding with SARS-CoV-2 Spike Protein. J Med Virol. 2020 Apr 6. doi: 10.1002/jmv.25832. (Epub ahead of print).

Mehta P, McAuley DF, Brown M, et al. COVID-19: consider cytokine storm syndromes and immunosuppression. Lancet 2020;395:1033-1034.

Cunningham AC, Goh HP, Koh D. Treatment of COVID-19: old tricks for new challenges. Crit Care 2020;24:91.

Lippi G, Plebani M. A modern and pragmatic definition of Laboratory Medicine. Clin Chem Lab Med. 2020 Feb 18. doi: 10.1515/cclm-2020-0114. (Epub ahead of print).

World Health Organization. Coronavirus disease 2019 (COVID-19) Situation Report. Available at: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports/. Last accessed, April 15, 2020.

Wang W, Xu Y, Gao R, et al. Detection of SARS-CoV-2 in Different Types of Clinical Specimens. JAMA. 2020 Mar 11. doi: 10.1001/jama.2020.3786. (Epub ahead of print).

Guo WL, Jiang Q, Ye F, et al. Effect of throat washings on detection of 2019 novel coronavirus. Clin Infect Dis. 2020 Apr 9. pii: ciaa416. doi: 10.1093/cid/ciaa416. (Epub ahead of print).

To KK, Tsang OT, Chik-Yan Yip C, et al. Consistent detection of 2019 novel coronavirus in saliva. Clin Infect Dis. 2020 Feb 12. doi: 10.1093/cid/ciaa149. (Epub ahead of print).

World Health Organization. Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases. Interim guidance - 2 March 2020.

Centers for Disease Control and Prevention. Interim Guidelines for Collecting, Handling, and Testing Clinical Specimens from Persons Under Investigation (PUIs) for Coronavirus Disease 2019 (COVID-19). Available at: https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html. Last accessed, April 15, 2020.

Lippi G, Simundic AM, Plebani M. Potential preanalytical and analytical vulnerabilities in the laboratory diagnosis of coronavirus disease 2019 (COVID-19). Clin Chem Lab Med. 2020 Mar 16. doi: 10.1515/cclm-2020-0285. (Epub ahead of print).

Corman VM, Landt O, Kaiser M, et al. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020 Jan;25(3). doi: 10.2807/1560-7917.ES.2020.25.3.2000045.

Centers for Disease Control and Prevention. CDC Tests for COVID-19. Available at: https://www.cdc.gov/coronavirus/2019-ncov/about/testing.html. Last accessed, April 15, 2020.

Nalla AK, Casto AM, Huang MW, et al. Comparative Performance of SARS-CoV-2 Detection Assays using Seven Different Primer/Probe Sets and One Assay Kit. J Clin Microbiol. 2020 Apr 8. doi: 10.1128/JCM.00557-20. (Epub ahead of print).

Galli C, Plebani M. Clinical laboratory and SARS-CoV-2 infection: where do we stand? Clin Chem Lab Med. 2020 Apr 2. doi: 10.1515/cclm-2020-0372. (Epub ahead of print).

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 Mar 23. doi: 10.1016/S1473-3099(20)30196-1. (Epub ahead of print).

Zhao J, Yuan Q, Wang H, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Infect Dis. 2020 Mar 28. pii: ciaa344. doi: 10.1093/cid/ciaa344. (Epub ahead of print).

Yang Y, Yang M, Shen C, et al. Evaluating the accuracy of different respiratory specimens in the laboratory diagnosis and monitoring the viral shedding of 2019-nCoV infections. MedRxiv 2020.02.11.20021493.

Ai T, Yang Z, Hou H, et al. Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases. Radiology. 2020 Feb 26:200642. doi: 10.1148/radiol.2020200642. (Epub ahead of print).

Wang X, Yao H, Xu X, et al. Limits of Detection of Six Approved RT-PCR Kits for the Novel SARS-coronavirus-2 (SARS-CoV-2). Clin Chem. 2020 Apr 13. doi: 10.1093/clinchem/hvaa099. (Epub ahead of print).

Zou L, Ruan F, Huang M, et al. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020;382:1177-1179.

Zhang JJ, Cao YY, Dong X, et al. Distinct characteristics of COVID-19 patients with initial rRT-PCR positive and negative results for SARS-CoV-2. Allergy. 2020 Apr 13. doi: 10.1111/all.14316. (Epub ahead of print).

Yan C, Cui J, Huang L, et al. Rapid and visual detection of 2019 novel coronavirus (SARS-CoV-2) by a reverse transcription loop-mediated isothermal amplification assay. Clin Microbiol Infect. 2020 Apr 7. doi: 10.1016/j.cmi.2020.04.001. (Epub ahead of print).

Park GS, Ku K, Baek SH, et al. Development of Reverse Transcription Loop-mediated Isothermal Amplification (RT-LAMP) Assays Targeting SARS-CoV-2. J Mol Diagn. 2020 Apr 7. doi: 10.1016/j.jmoldx.2020.03.006. (Epub ahead of print).

Poljak M, Korva M, Knap Gašper N, et al. Clinical evaluation of the cobas SARS-CoV-2 test and a diagnostic platform switch during 48 hours in the midst of the COVID-19 pandemic.J Clin Microbiol. 2020 Apr 10. pii: JCM.00599-20. doi: 10.1128/JCM.00599-20. (Epub ahead of print).

Fierz W. Basic problems of serological laboratory diagnosis. Methods Mol Med 2004;94:393-427.

Guo L, Ren L, Yang S, et al. Profiling Early Humoral Response to Diagnose Novel Coronavirus Disease (COVID-19). Clin Infect Dis. 2020 Mar 21. pii: ciaa310. doi: 10.1093/cid/ciaa310. (Epub ahead of print).

Padoan A, Cosma C, Sciacovelli L, et al. Analytical performances of a chemiluminescence immunoassay for 2019-nCov IgM/ IgG and antibody kinetics. Clin Chem Lab Med. 2020. Doi: 10.1515/cclm-2020-0443.

Lippi G, Salvagno GL, Pegoraro M, et al. Assessment of immune response to SARS-CoV-2 with fully-automated MAGLUMI 2019-nCoV IgG and IgM chemiluminescence immunoassays. Clin Chem Lab Med. 2020. Doi: 10.1515/cclm-2020-0473.

Jin Y, Wang M, Zuo Z, et al. Diagnostic value and dynamic variance of serum antibody in coronavirus disease 2019. Int J Infect Dis. 2020 Apr 3. pii: S1201-9712(20)30198-3. doi: 10.1016/j.ijid.2020.03.065. (Epub ahead of print).

Du Z, Zhu F, Guo F, et al. Detection of antibodies against SARS-CoV-2 in patients with COVID-19. J Med Virol. 2020 Apr 3. doi: 10.1002/jmv.25820. (Epub ahead of print).

Pan Y, Li X, Yang G, et al. Serological immunochromatographic approach in diagnosis with SARS-CoV-2 infected COVID-19 patients. J Infect. 2020 Apr 10. pii: S0163-4453(20)30175-4. doi: 10.1016/j.jinf.2020.03.051. (Epub ahead of print).

Béné MC, de Carvalho M, Eveillard M, et al. Good IgA bad IgG in SARS-CoV-2 infection? Clin Infect Dis. 2020 Apr 11. pii: ciaa426. doi: 10.1093/cid/ciaa426. (Epub ahead of print).

Haveri A, Smura T, Kuivanen S, et al. Serological and molecular findings during SARS-CoV-2 infection: the first case study in Finland, January to February 2020. Euro Surveill. 2020 Mar;25(11). doi: 10.2807/1560-7917.ES.2020.25.11.2000266.

Okba NMA, Müller MA, Li W, et al. Severe Acute Respiratory Syndrome Coronavirus 2-Specific Antibody Responses in Coronavirus Disease 2019 Patients. Emerg Infect Dis. 2020 Apr 8;26(7). doi: 10.3201/eid2607.200841. (Epub ahead of print).

Lin Q, Zhu L, Ni Z, et al. Duration of serum neutralizing antibodies for SARS-CoV-2: Lessons from SARS-CoV infection. J Microbiol Immunol Infect. 2020 Mar 25. pii: S1684-1182(20)30075-X. doi: 10.1016/j.jmii.2020.03.015. (Epub ahead of print).

Vashist SK. In Vitro Diagnostic Assays for COVID-19: Recent Advances and Emerging Trends. Diagnostics 2020;10:202.

European Center for Disease Control and Prevention. An overview of the rapid test situation for COVID-19 diagnosis in the EU/EEA. Last Update: 1 April 2020.

[No Author Listed]. Spain and Other Countries Return Defective COVID-19 Test Kits to China. Available at: https://www.sciencetimes.com/articles/25145/20200329/spain-and-other-countries-return-defective-covid-19-test-kits-to-china.htm. Last accessed, April 20, 2020.

Cassaniti I, Novazzi F, Giardina F, et al. Performance of VivaDiagTM COVID-19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID-19 in acute patients referring to emergency room department. J Med Virol. 2020 Mar 30. doi: 10.1002/jmv.25800. (Epub ahead of print).

Lippi G, Plebani M. The critical role of laboratory medicine during coronavirus disease 2019 (COVID-19) and other viral outbreaks. Clin Chem Lab Med. 2020 Mar 19. doi: 10.1515/cclm-2020-0240. (Epub ahead of print).

[No Author Listed]. Coronavirus, the “immunity license” in Veneto: carpet antibody test. Available at: https://www.news1.news/i/2020/04/coronavirus-the-immunity-license-in-veneto-carpet-antibody-test.html. Last accessed: Last Update 15 April, 2020.

Remuzzi A, Remuzzi G. COVID-19 and Italy: what next? Lancet. 2020 Mar 13. doi: 10.1016/S0140-6736(20)30627-9. (Epub ahead of print).

Moghadas SM, Shoukat A, Fitzpatrick MC, et al. Projecting hospital utilization during the COVID-19 outbreaks in the United States. Proc Natl Acad Sci U S A. 2020 Apr 3. pii: 202004064. doi: 10.1073/pnas.2004064117. (Epub ahead of print).

Lippi G, Plebani M. Laboratory abnormalities in patients with COVID-2019 infection. Clin Chem Lab Med. 2020 Mar 3. doi: 10.1515/cclm-2020-0198. (Epub ahead of print).

Henry BM, Santos de Oliveira MH, Benoit S, et al. Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 (COVID-19): a meta-analysis. Clin Chem Lab Med. 2020. Doi: 10.1515/cclm-2020-0369.

Lippi G, Favaloro EJ. D-dimer is Associated with Severity of Coronavirus Disease 2019: A Pooled Analysis. Thromb Haemost. 2020 Apr 3. doi: 10.1055/s-0040-1709650. (Epub ahead of print).

Lippi G, Plebani M. Procalcitonin in patients with severe coronavirus disease 2019 (COVID-19): A meta-analysis. Clin Chim Acta 2020;505:190-1.

Lippi G, Plebani M. Laboratory Medicine resilience during coronavirus disease 2019 (COVID-19) pandemic. Adv Lab Med 2020. Doi: 10.1515/almed-2020-0035.

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Published

11-05-2020

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Current laboratory diagnostics of coronavirus disease 2019 (COVID-19). Acta Biomed [Internet]. 2020 May 11 [cited 2024 Apr. 18];91(2):137-45. Available from: https://mattioli1885journals.com/index.php/actabiomedica/article/view/9548

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