Systematic review with meta-analysis of the accuracy of diagnostic tests for COVID-19

• Published in: American journal of infection control Vol. 49; no. 1; pp. 21 - 29
• Main Authors: Böger, Beatriz, Fachi, Mariana M., Vilhena, Raquel O., Cobre, Alexandre F., Tonin, Fernanda S., Pontarolo, Roberto
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.01.2021; Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc
• Subjects: Antibodies, Viral - immunology; Coronavirus; Coronavirus Envelope Proteins - genetics; Coronavirus RNA-Dependent RNA Polymerase - genetics; COVID-19 - diagnosis; COVID-19 - immunology; COVID-19 Nucleic Acid Testing; COVID-19 Serological Testing; COVID-19 Testing; Evidence; Humans; Immunoglobulin G - immunology; Immunoglobulin M - immunology; Lung - diagnostic imaging; Major; SARS-CoV-2; SARS-CoV-2 - genetics; SARS-CoV-2 - immunology; Sensitivity; Sensitivity and Specificity; Specificity; Tomography, X-Ray Computed; Evidence; SARS-CoV-2; Sensitivity; Specificity; Coronavirus
• ISSN: 0196-6553; 1527-3296; 1527-3296
• DOI: 10.1016/j.ajic.2020.07.011

•RT-PCR followed by CT shows high sensitivity for detecting COVID-19.•Immunological tests should use a combination of IgG and IgM.•The genes E and RdRp present high analytical sensitivity to detect the virus.•Assays for molecular diagnosis should employ 2-target systems.•Studies of diagnostic tests for COVID-19 are of moderate methodological quality. To collate the evidence on the accuracy parameters of all available diagnostic methods for detecting SARS-CoV-2. A systematic review with meta-analysis was performed. Searches were conducted in Pubmed and Scopus (April 2020). Studies reporting data on sensitivity or specificity of diagnostic tests for COVID-19 using any human biological sample were included. Sixteen studies were evaluated. Meta-analysis showed that computed tomography has high sensitivity (91.9% [89.8%-93.7%]), but low specificity (25.1% [21.0%-29.5%]). The combination of IgM and IgG antibodies demonstrated promising results for both parameters (84.5% [82.2%-86.6%]; 91.6% [86.0%-95.4%], respectively). For RT-PCR tests, rectal stools/swab, urine, and plasma were less sensitive while sputum (97.2% [90.3%-99.7%]) presented higher sensitivity for detecting the virus. RT-PCR remains the gold standard for the diagnosis of COVID-19 in sputum samples. However, the combination of different diagnostic tests is highly recommended to achieve adequate sensitivity and specificity.