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Diagnostic Accuracy Estimates for COVID-19 Real-Time Polymerase Chain Reaction and Lateral Flow Immunoassay Tests With Bayesian Latent-Class Models.
Am J Epidemiol ; 190(8): 1689-1695, 2021 08 01.
Article in English | MEDLINE | ID: covidwho-1337252
ABSTRACT
Our objective was to estimate the diagnostic accuracy of real-time polymerase chain reaction (RT-PCR) and lateral flow immunoassay (LFIA) tests for coronavirus disease 2019 (COVID-19), depending on the time after symptom onset. Based on the cross-classified results of RT-PCR and LFIA, we used Bayesian latent-class models, which do not require a gold standard for the evaluation of diagnostics. Data were extracted from studies that evaluated LFIA (immunoglobulin G (IgG) and/or immunoglobulin M (IgM)) assays using RT-PCR as the reference method. The sensitivity of RT-PCR was 0.68 (95% probability interval (PrI) 0.63, 0.73). IgG/M sensitivity was 0.32 (95% PrI0.23; 0.41) for the first week and increased steadily. It was 0.75 (95% PrI 0.67; 0.83) and 0.93 (95% PrI 0.88; 0.97) for the second and third weeks after symptom onset, respectively. Both tests had a high to absolute specificity, with higher point median estimates for RT-PCR specificity and narrower probability intervals. The specificity of RT-PCR was 0.99 (95% PrI 0.98; 1.00). and the specificity of IgG/IgM was 0.97 (95% PrI 0.92, 1.00), 0.98 (95% PrI 0.95, 1.00) and 0.98 (95% PrI 0.94, 1.00) for the first, second, and third weeks after symptom onset. The diagnostic accuracy of LFIA varies with time after symptom onset. Bayesian latent-class models provide a valid and efficient alternative for evaluating the rapidly evolving diagnostics for COVID-19, under various clinical settings and different risk profiles.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / Real-Time Polymerase Chain Reaction / COVID-19 Nucleic Acid Testing / COVID-19 Serological Testing / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Am J Epidemiol Year: 2021 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / Real-Time Polymerase Chain Reaction / COVID-19 Nucleic Acid Testing / COVID-19 Serological Testing / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Am J Epidemiol Year: 2021 Document Type: Article