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Review of analytical performance of COVID-19 detection methods

Basant Giri, Shishir Pandey, Retina Shrestha and 3 more

Analytical and Bioanalytical Chemistry · 2020 · Review · CC BY

doi:10.1007/s00216-020-02889-x

Abstract

In the recent SARS-CoV-2 pandemic, public health experts have emphasized testing, tracking infected people, and tracing their contacts as an effective strategy to reduce the spread of the virus. Several diagnostic methods are reported for detecting the coronavirus in clinical, research, and public health laboratories. Some tests detect the infection directly by detecting the viral RNA and other tests detect the infection indirectly by detecting the host antibodies. A diagnostic test during the pandemic should help make an appropriate clinical decision in a short period of time. Recently reported diagnostic methods for SARS-CoV-2 have varying throughput, batching capacity, requirement of infrastructure setting, analytical performance, and turnaround times ranging from a few minutes to several hours. These factors should be considered while selecting a reliable and rapid diagnostic method to help make an appropriate decision and prompt public health interventions. This paper reviews recent SARS-CoV-2 diagnostic methods published in journals and reports released by regulatory agencies. We compared the analytical efficiency including limit of detection, sensitivity, specificity, and throughput. In addition, we also looked into ease of use, affordability, and availability of accessories. Finally, we discuss the limitations of the methods and provide our perspectives on priorities for future test development.

References 97

  1. 1.

    WHO. Coronavirus disease (COVID-19) situation reports https://www.who.int/emergencies/diseases/novel-coronavirus-2019/situation-reports. Accessed 28 Apr 2020.

    Not in our library

  2. 2.
  3. 3.
  4. 4.

    Lu R, Zhao X, Li J, Niu P, Yang B, Wu H, Wang W, Song H, Huang B, Zhu N. Genomic characterization and epidemiology of 2019 novel coronavirus: implications for virus origins and receptor binding. Lancet. 2020;395:565-574.

    Not in our library10.1016/s0140-6736(20)30251-8

  5. 5.
  6. 6.

    Lam TT-Y, Shum MH-H, Zhu H-C, Tong Y-G, Ni X-B, Liao Y-S, Wei W, Cheung WY-M, Li W-J, Li F. Identifying SARS-CoV-2 related coronaviruses in Malayan pangolins. Nature. 2020;579:1-6.

    Not in our library10.1038/s41586-020-2169-0

  7. 7.

    Cheng MP, Papenburg J, Desjardins M, Kanjilal S, Quach C, Libman M, et al. Diagnostic testing for severe acute respiratory syndrome–related coronavirus-2: a narrative review. Ann Intern Med. 2020. 10.7326/M20-1301.

    Not in our library10.7326/m20-1301

  8. 8.
  9. 9.

    Vogels CBF, Brito AF, Wyllie AL, et al. Analytical sensitivity and efficiency comparisons of SARS-This pre-print paper has now been published in a peer review journal. Please replace with following: CoV-2 RT–qPCR primer–probe sets. Nat Microbiol. 2020. 10.1038/s41564-020-0761-6.

    Not in our library10.1038/s41564-020-0761-6

  10. 10.

    Broughton JP, Deng X, Yu G, Fasching CL, Servellita V, Singh J, et al. CRISPR–Cas12-based detection of SARS-CoV-2. Nat Biotechnol. 2020. 10.1038/s41587-020-0513-4.

    Not in our library10.1038/s41587-020-0513-4

  11. 11.

    Hou T, Zeng W, Yang M, Chen W, Ren L, Ai J, et al. Development and evaluation of a CRISPR-based diagnostic for 2019-novel coronavirus. medRxiv. 2020. 10.1101/2020.02.22.20025460.

    Not in our library

  12. 12.

    Joung J, Ladha A, Saito M, Segel M, Bruneau R, Meei-li WH, et al. Point-of-care testing for COVID-19 using SHERLOCK diagnostics. medRxiv. 2020. 10.1101/2020.05.04.20091231

    Not in our library

  13. 13.

    Carter LJ, Garner LV, Smoot JW, Li Y, Zhou Q, Saveson CJ, Sasso JM, Gregg AC, Soares DJ, Beskid TR. Assay techniques and test development for COVID-19 diagnosis. ACS Cent Sci. 2020;6:591-605.

    Not in our library10.1021/acscentsci.0c00501

  14. 14.

    Green K, Graziadio S, Turner P, Fanshawe T, Allen J. Molecular and antibody point-of-care tests to support the screening, diagnosis and monitoring of COVID-19. Oxford COVID-19 Evidence Service. 2020. https://www.cebm.net/covid-19/molecular-and-antibody-point-of-care-tests-to-support-the-screening-diagnosis-and-monitoring-of-covid-19. Accessed 2 July 2020.

    Not in our library

  15. 15.

    Xue G, Li S, Zhang W, Du B, Cui J, Yan C, et al. A reverse-transcription recombinase-aided amplification assay for rapid detection of the 2019 novel coronavirus [SARS-CoV-2]. Anal Chem. 2020. 10.1021/acs.analchem.0c01032.

    Not in our library10.1021/acs.analchem.0c01032

  16. 16.

    Ai T, Yang Z, Hou H, Zhan C, Chen C, Lv W, 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;200642. 10.1148/radiol.2020200642.

    Not in our library10.1148/radiol.2020200642

  17. 17.

    Udugama B, Kadhiresan P, Kozlowski HN, Malekjahani A, Osborne M, Li VY, Chen H, Mubareka S, Gubbay JB, Chan WC. Diagnosing COVID-19: the disease and tools for detection. ACS Nano. 2020;14:3822-3835.

    Not in our library10.1021/acsnano.0c02624

  18. 18.

    Qiu G, Gai Z, Tao Y, Schmitt J, Kullak-Ublick GA, Wang J. Dual-functional plasmonic photothermal biosensors for highly accurate severe acute respiratory syndrome coronavirus 2 detection. ACS Nano. 2020;14:5268-5277.

    Not in our library10.1021/acsnano.0c02439

  19. 19.

    Seo G, Lee G, Kim MJ, Baek S-H, Choi M, Ku KB, Lee C-S, Jun S, Park D, Kim HG. Rapid detection of COVID-19 causative virus [SARS-CoV-2] in human nasopharyngeal swab specimens using field-effect transistor-based biosensor. ACS Nano. 2020;14:5135-5142.

    Not in our library10.1021/acsnano.0c02823

  20. 20.

    Krüttgen A, Cornelissen CG, Dreher M, Hornef M, Imöhl M, Kleines M. Comparison of four new commercial serologic assays for determination of SARS-CoV-2 IgG. J Clin Virol. 2020:104394. 10.1016/j.jcv.2020.104394.

    Not in our library10.1016/j.jcv.2020.104394

  21. 21.

    Lassaunière R, Frische A, Harboe ZB, Nielsen AC, Fomsgaard A, Krogfelt KA, et al. Evaluation of nine commercial SARS-CoV-2 immunoassays. Medrxiv. 2020. 10.1101/2020.04.09.20056325.

    Not in our library

  22. 22.

    U.S. FDA. FAQs on emergency use authorizations [EUAs] for medical devices during the COVID-19 pandemic. FDA. 2020. https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-emergency-use-authorizations-euas-medical-devices-during-covid-19-pandemic. Accessed 2 July 2020.

    Not in our library

  23. 23.

    Wang W, Xu Y, Gao R, Lu R, Han K, Wu G, Tan W. Detection of SARS-CoV-2 in different types of clinical specimens. JAMA. 2020;323:1843-1844.

    Not in our library10.1001/jama.2020.3786

  24. 24.

    Ahmed W, Angel N, Edson J, Bibby K, Bivins A, O’Brien JW, et al. First confirmed detection of SARS-CoV-2 in untreated wastewater in Australia: a proof of concept for the wastewater surveillance of COVID-19 in the community. Sci Total Environ. 2020;138764. 10.1016/j.scitotenv.2020.138764.

    Not in our library10.1016/j.scitotenv.2020.138764

  25. 25.

    Feng W, Newbigging A, Le C, Pang B, Peng H, Cao Y, Wu J, Abbas G, Song J, Wang D-B, Cui M, Tao J, Tyrrell DL, Zhang X-E, Zhang H, Le C. Molecular diagnosis of COVID-19: challenges and research needs. Anal Chem. 2020;92:10196-10209.

    Not in our library10.1021/acs.analchem.0c02060

  26. 26.

    See A, Toh ST. Respiratory sampling for severe acute respiratory syndrome coronavirus 2: an overview. Head Neck. 2020;42:1652–1656. 10.1002/hed.26232.

    Not in our library10.1002/hed.26232

  27. 27.

    PHLN. PHLN Guidance on laboratory testing for SARS-CoV-2 [the virus that causes COVID-19]. PHLN. 2020. https://www.health.gov.au/sites/default/files/documents/2020/02/phln-guidance-on-laboratory-testing-for-sars-cov-2-the-virus-that-causes-covid-19.pdf. Accessed 2 July 2020.

    Not in our library

  28. 28.

    CDC. Coronavirus disease 2019 [COVID-19] https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html. Accessed 28 Apr 2020.

    Not in our library

  29. 29.

    Bendavid E, Mulaney B, Sood N, Shah S, Ling E, Bromley-Dulfano R, et al. COVID-19 antibody seroprevalence in Santa Clara County, California. medRxiv. 2020. 10.1101/2020.04.14.20062463.

    Not in our library10.1093/ije/dyab010

  30. 30.

    WHO. Laboratory testing for coronavirus disease 2019 [COVID-19] in suspected human cases: interim guidance, 2 March 2020, World Health Organization. 2020. https://apps.who.int/iris/handle/10665/331329?show=full. Accessed 2 July 2020.

    Not in our library

  31. 31.

    Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen H-L, Peiris M, Wu J. SARS-CoV-2 viral load in upper respiratory specimens of infected patients. N Engl J Med. 2020;382:1177-1179.

    Not in our library10.1056/nejmc2001737

  32. 32.

    Wang X, Tan L, Wang X, Liu W, Lu Y, Cheng L, Sun Z. Comparison of nasopharyngeal and oropharyngeal swabs for SARS-CoV-2 detection in 353 patients received tests with both specimens simultaneously. Int J Infect Dis. 2020;94:107-109.

    Not in our library10.1016/j.ijid.2020.04.023

  33. 33.

    Winichakoon P, Chaiwarith R, Liwsrisakun C, Salee P, Goonna A, Limsukon A, Kaewpoowat Q. Negative nasopharyngeal and oropharyngeal swabs do not rule out COVID-19. J Clin Microbiol. 2020;58(5):e00297-e00220.

    Not in our library10.1128/jcm.00297-20

  34. 34.

    Berenger BM, Fonseca K, Schneider AR, Hu J, Zelyas N. Sensitivity of nasopharyngeal, nasal and throat swab for the detection of SARS-CoV-2, preprint, Infectious Diseases [except HIV/AIDS]. 2020. 10.1101/2020.05.05.20084889.

    Not in our library

  35. 35.

    Irving SA, Vandermause MF, Shay DK, Belongia EA. Comparison of nasal and nasopharyngeal swabs for influenza detection in adults. Clin Med Res. 2012;10:215-218.

    Not in our library10.3121/cmr.2012.1084

  36. 36.

    OASH. Nasal [anterior nasal] specimen collection for SARS-CoV-2 diagnostic testing. https://www.cdc.gov/coronavirus/2019-ncov/downloads/OASH-nasal-specimen-collection-fact-sheet.pdf [accessed May 20, 2020].

    Not in our library

  37. 37.

    Mackay IM, Arden KE, Nitsche A. Real-time PCR in virology. Nucleic Acids Res. 2002;30:1292-1305.

    Not in our library10.1093/nar/30.6.1292

  38. 38.

    Drosten C, Seilmaier M, Corman VM, Hartmann W, Scheible G, Sack S, Guggemos W, Kallies R, Muth D, Junglen S, Müller MA, Haas W, Guberina H, Röhnisch T, Schmid-Wendtner M, Aldabbagh S, Dittmer U, Gold H, Graf P, Bonin F, Rambaut A, Wendtner C-M. Clinical features and virological analysis of a case of Middle East respiratory syndrome coronavirus infection. Lancet Infect Dis. 2013;13:745-751.

    Not in our library10.1016/s1473-3099(13)70154-3

  39. 39.

    WHO. Molecular assays to diagnose COVID-19: summary table of available protocols. World Health Organization. 2020. https://www.who.int/publications/m/item/molecular-assays-to-diagnose-covid-19-summary-table-of-available-protocols. Accessed 2 July 2020.

    Not in our library

  40. 40.
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