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Review
. 2021 Aug;15(8):993-1002.
doi: 10.1080/17476348.2021.1917389. Epub 2021 Apr 25.

False-positive and false-negative COVID-19 cases: respiratory prevention and management strategies, vaccination, and further perspectives

Affiliations
Review

False-positive and false-negative COVID-19 cases: respiratory prevention and management strategies, vaccination, and further perspectives

Dimitra S Mouliou et al. Expert Rev Respir Med. 2021 Aug.

Abstract

Introduction: A novel Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) was reported via nucleic acid identification in December, 2019. Accuracy of SARS-CoV-2 diagnostic assays has emerged as a major barrier to COVID-19 diagnosis, particularly in cases requiring urgent or emergent treatment.Areas covered: In this review, we explore the major reasons for false-positive and false-negative SARS-CoV-2 test results. How clinical characteristics, specific respiratory comorbidities and SARS-CoV-2 vaccination impact on existing diagnostic assays are highlighted. Different COVID-19 management algorithms based on each test and limitations are thoroughly presented.Expert opinion: The diagnostic accuracy and the capacity of every available assay, which need to be interpreted in the light of the background incidence of SARS-CoV-2 infection in the communities in which they are used, are essential in order to minimize the number of falsely tested cases. Automated testing platforms may enhance diagnostic accuracy by minimizing the potential for human error in assays' performance. Prior immunization against SARS-CoV-2 impairs the utility of serologic testing of suspected COVID-19 cases. Future avenues of research to evaluate lung tissue innate immune responses hold promise as a target for research to optimize SARS-CoV-2 and future infections' testing accuracy.

Keywords: COVID-19; false-negative; false-positive; management; respiratory; vaccination.

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Figures

Figure 1.
Figure 1.
Respiratory prediction of an endogenous inhibited PCR result
Figure 2..
Figure 2..
Algorithm for the management of suspected COVID-19 cases during the course of the pandemic

References

    1. Zhu N, Zhang D, Wang W, et al. China novel coronavirus investigating and research team. A novel coronavirus from patients with pneumonia in China, 2019. N Engl J Med. 2020;382(8):727–733. - PMC - PubMed
    1. WHO [Internet] . Laboratory testing for coronavirus disease 2019 (COVID-19) in suspected human cases; [cited 2021. February 16] Available from: https://apps.who.int/iris/bitstream/handle/10665/331329/WHO-COVID-19-lab...
    1. Deeks JJ, Dinnes J, Takwoingi Y, et al. Antibody tests for identification of current and past infection with SARS-CoV-2. Cochrane Database Syst Rev. 2020. June. - PMC - PubMed
    1. Watson J, Whiting PF, Brush JE.. Interpreting a covid-19 test result. BMJ. 2020;369:m1808. - PubMed
    1. Wikramaratna PS, Paton RS, Ghafari M, et al. Estimating the false-negative test probability of SARS-CoV-2 by RT-PCR. Euro Surveill. 2020;25(50):2000568. - PMC - PubMed

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