COVID-19 Evidence Alerts
from McMaster PLUSTM

Current best evidence for clinical care (more info)

Diagnosis Moura DTH, McCarty TR, Ribeiro IB, et al. Diagnostic Characteristics of Serological-Based COVID-19 Testing: A Systematic Review and Meta-Analysis. Clinics (Sao Paulo). 2020;75:e2212. doi: 10.6061/clinics/2020/e2212. Epub 2020 Aug 10.
Abstract

Serologic testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promises to assist in assessing exposure to and confirming the diagnosis of coronavirus disease 2019 (COVID-19), and to provide a roadmap for reopening countries worldwide. Considering this, a proper understanding of serologic-based diagnostic testing characteristics is critical. The aim of this study was to perform a structured systematic review and meta-analysis to evaluate the diagnostic characteristics of serological-based COVID-19 testing. Electronic searches were performed using Medline (PubMed), EMBASE, and Cochrane Library. Full-text observational studies that reported IgG or IgM diagnostic yield and used nucleic acid amplification tests (NAATs) of respiratory tract specimens, as a the reference standard in English language were included. A bivariate model was used to compute pooled sensitivity, specificity, positive/negative likelihood ratio (LR), diagnostic odds ratio (OR), and summary receiver operating characteristic curve (SROC) with corresponding 95% confidence intervals (CIs). Five studies (n=1,166 individual tests) met inclusion criteria. The pooled sensitivity, specificity, and diagnostic accuracy for IgG was 81% [(95% CI, 61-92);I2=95.28], 97% [(95% CI, 78-100);I2=97.80], and 93% (95% CI, 91-95), respectively. The sensitivity, specificity, and accuracy for IgM antibodies was 80% [(95% CI, 57-92);I2=94.63], 96% [(95% CI, 81-99);I2=92.96] and 95% (95% CI, 92-96). This meta-analysis demonstrates suboptimal sensitivity and specificity of serologic-based diagnostic testing for SARS-CoV-2 and suggests that antibody testing alone, in its current form, is unlikely to be an adequate solution to the difficulties posed by COVID-19 and in guiding future policy decisions regarding social distancing and reopening of the economy worldwide.

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Occupational and Environmental Health
Infectious Disease
Respirology/Pulmonology
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Emergency Medicine
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Comments from MORE raters

Emergency Medicine rater

Most practitioners are already well aware of the limitations of serology testing due to the high heterogeneity of serology test kits offered, as shown in this meta-analysis.

Emergency Medicine rater

This is a good summary of fairly well-disseminated current knowledge. There is not much new, however.

Occupational and Environmental Health rater

This is a formal analysis of what is already known to any physician who is familiar with these tests.

Occupational and Environmental Health rater

There is significant heterogeneity, but the likelihood ratios are quite good IgG +ve 27, -ve 0.2; IgM +ve 20; -ve 0.21. It emphasizes my concern with using PPV and NPV. This test performs well to rule in with a medium to high pre-test probability, and will be not bad for ruling out the disease. Eg pre-test prob 20% will yield a +ve post test of 87% and a -ve post test 4.8%. for IgG. Not bad at all.

Public Health rater

The study does not take into account the more than 150 serological tests available.

Public Health rater

This is on COVID-19 antibody testing; the pooled analysis supports conclusions to date. Antibody testing is unreliable. Until better methods are developed, its use is limited.