False-negative results of initial RT-PCR assays for COVID-19 : A systematic review
Arevalo-Rodriguez, Ingrid (Centro de Investigación Biomédica en Red de Epidemiología y Salud Pública)
Buitrago-Garcia, Diana (University of Bern)
Simancas-Racines, Daniel (Universidad UTE)
Zambrano-Achig, Paula (Hospital Universitario Ramón y Cajal (Madrid))
Campo, Rosa del (Hospital Universitario Ramón y Cajal (Madrid))
Ciapponi, Agustin (Instituto de Efectividad Clínica y Sanitaria (IECS-CONICET))
Sued, Omar (Fundación Huésped)
Martínez García, Laura (Institut d'Investigació Biomèdica Sant Pau)
Rutjes, Anne W. (University of Bern)
Low, Nicola (University of Bern)
Bossuyt, Patrick M. (University of Amsterdam)
Perez-Molina, José A. (Instituto Ramón y Cajal de Investigación Sanitaria (Madrid))
Zamora, Javier (University of Birmingham)
Universitat Autònoma de Barcelona [...] Mostra tots els 14 autors

Data:	2020
Resum:	A false-negative case of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is defined as a person with suspected infection and an initial negative result by reverse transcription-polymerase chain reaction (RT-PCR) test, with a positive result on a subsequent test. False-negative cases have important implications for isolation and risk of transmission of infected people and for the management of coronavirus disease 2019 (COVID-19). We aimed to review and critically appraise evidence about the rate of RT-PCR false-negatives at initial testing for COVID-19. We searched MEDLINE, EMBASE, LILACS, as well as COVID-19 repositories, including the EPPI-Centre living systematic map of evidence about COVID-19 and the Coronavirus Open Access Project living evidence database. Two authors independently screened and selected studies according to the eligibility criteria and collected data from the included studies. The risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. We calculated the proportion of false-negative test results using a multilevel mixed-effect logistic regression model. The certainty of the evidence about false-negative cases was rated using the GRADE approach for tests and strategies. All information in this article is current up to July 17, 2020. We included 34 studies enrolling 12,057 COVID-19 confirmed cases. All studies were affected by several risks of bias and applicability concerns. The pooled estimate of false-negative proportion was highly affected by unexplained heterogeneity (tau-squared = 1. 39; 90% prediction interval from 0. 02 to 0. 54). The certainty of the evidence was judged as very low due to the risk of bias, indirectness, and inconsistency issues. There is substantial and largely unexplained heterogeneity in the proportion of false-negative RT-PCR results. The collected evidence has several limitations, including risk of bias issues, high heterogeneity, and concerns about its applicability. Nonetheless, our findings reinforce the need for repeated testing in patients with suspicion of SARS-Cov-2 infection given that up to 54% of COVID-19 patients may have an initial false-negative RT-PCR (very low certainty of evidence).
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Publicat a:	PloS one, Vol. 15 Núm. 12 December (december 2020) , p. e0242958, ISSN 1932-6203

DOI: 10.1371/journal.pone.0242958
PMID: 33301459

19 p, 1022.0 KB

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