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Clin Microbiol Infect . Nucleic-acid-amplification tests from respiratory samples for the diagnosis of coronavirus infections: systematic review and meta-analysis

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  • Clin Microbiol Infect . Nucleic-acid-amplification tests from respiratory samples for the diagnosis of coronavirus infections: systematic review and meta-analysis


    Clin Microbiol Infect


    . 2020 Nov 11;S1198-743X(20)30695-9.
    doi: 10.1016/j.cmi.2020.11.002. Online ahead of print.
    Nucleic-acid-amplification tests from respiratory samples for the diagnosis of coronavirus infections: systematic review and meta-analysis


    Mona Mustafa Hellou 1 , Anna G?rska 2 , Fulvia Mazzaferri 2 , Eleonora Cremonini 2 , Elisa Gentilotti 2 , Pasquale De Nardo 2 , Itamar Poran 3 , Mariska Leeflang 4 , Evelina Tacconelli 5 , Mical Paul 6



    Affiliations

    Abstract

    Background: Management and control of COVID-19 relies on reliable diagnostic testing.
    Objectives: To evaluate the diagnostic test accuracy (DTA) of nucleic acid-amplification tests (NAAT) for the diagnosis of coronavirus infections.
    Data sources: PubMed, Web of Science, the Cochrane Library, Embase, Open Grey and conference proceeding until May 2019. PubMed and medRxiv were updated on 31 August, 2020 for COVID-19.
    Study eligibility: Studies reporting on agreement rates between different NAATs using clinical samples.
    Participants: Symptomatic patients with suspected upper or lower respiratory tract coronavirus infection.
    Methods: The new NAAT was defined as the index test and the existing NAAT as reference standard. Data were extracted independently in duplicate. Risk of bias was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. Confidence regions (CR) surrounding summary sensitivity/specificity pooled by bivariate meta-analysis are reported. Heterogeneity was assessed using meta-regression.
    Results: Fifty-one studies were included; 22 including 10,181 persons before COVID-19 and 29 including 8,742 persons diagnosing SARS-CoV-2. The overall summary sensitivity was 89.1% (95% CR 84.0-92.7%), specificity 98.9% (95% CR 98.0-99.4%). Nearly all evaluated different PCRs both as index and reference standard. Real-time-RT PCR essays resulted in significantly higher sensitivity than other tests. Reference standards at high risk of bias possibly exaggerated specificity. The pooled sensitivity and specificity of studies evaluating SARS-COV-2 were 90.4% (95% CR 83.7-94.5%) and 98.1% (95% CR 95.9-99.2), respectively. SARS-COV-2 studies using lower respiratory tract samples, real-time RT-PCR and tests targeting the N, S or more than one gene showed higher sensitivity and RT-LAMP-based essays, especially when targeting only the RdRp gene, showed significantly lower sensitivity compared to other studies.
    Conclusions: Pooling all studies to date shows that about 10% of patients with coronavirus infections might be missed on average with PCR tests. Variables affecting sensitivity and specificity can be used for test selection and development.




    Copyright ? 2020. Published by Elsevier Ltd.
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