Meta-analysis of diagnostic performance of serology tests for COVID-19: impact of assay design and post-symptom-onset intervals

• Published in: Emerging microbes & infections Vol. 9; no. 1; pp. 2200 - 2211
• Main Authors: Wang, Hongyu, Ai, Jingwen, Loeffelholz, Michael J., Tang, Yi-Wei, Zhang, Wenhong
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 01.01.2020; Taylor & Francis Ltd; Taylor & Francis Group
• Subjects: Accuracy; Antibodies, Viral - blood; Antibodies, Viral - immunology; Antigens, Viral - immunology; Betacoronavirus - immunology; Clinical Laboratory Techniques - methods; Clinical Laboratory Techniques - standards; Coronavirus Infections - diagnosis; Coronavirus Infections - immunology; Coronavirus Infections - virology; Coronaviruses; COVID-19; COVID-19 Testing; Humans; Immunoassay; Immunoassay - methods; Immunoassay - standards; immunoassays; Immunoglobulin G - blood; Immunoglobulin G - immunology; Immunoglobulin M - blood; Immunoglobulin M - immunology; Meta-analysis; metanalysis; Pandemics; Pneumonia, Viral - diagnosis; Pneumonia, Viral - immunology; Pneumonia, Viral - virology; Publication Bias; SARS-CoV-2; Sensitivity and Specificity; Serologic Tests - methods; Serologic Tests - standards; Serology; Symptom Assessment; COVID-19; immunoassays; SARS-CoV-2; metanalysis; serology
• ISSN: 2222-1751; 2222-1751
• DOI: 10.1080/22221751.2020.1826362

Serology detection is recognized for its sensitivity in convalescent patients with COVID-19, in comparison with nucleic acid amplification tests (NAATs). This article aimed to evaluate the diagnostic accuracy of serologic methods for COVID-19 based on assay design and post-symptom-onset intervals. Two authors independently searched PubMed, Cochrane library, Ovid, EBSCO for case-control, longitudinal and cohort studies that determined the diagnostic accuracy of serology tests in comparison with NAATs in COVID-19 cases and used QUADAS-2 for quality assessment. Pooled accuracy was analysed using INLA method. A total of 27 studies were included in this meta-analysis, with 4 cohort, 16 case-control and 7 longitudinal studies and 4565 participants. Serology tests had the lowest sensitivity at 0-7 days after symptom onset and the highest at >14 days. TAB had a better sensitivity than IgG or IgM only. Using combined nucleocapsid (N) and spike(S) protein had a better sensitivity compared to N or S protein only. Lateral flow immunoassay (LFIA) had a lower sensitivity than enzyme-linked immunoassay (ELISA) and chemiluminescent immunoassay (CLIA). Serology tests will play an important role in the clinical diagnosis for later stage COVID-19 patients. ELISA tests, detecting TAB or targeting combined N and S proteins had a higher diagnostic sensitivity compared to other methods.