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Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
Mayara Lisboa Bastos1,2, Gamuchirai Tavaziva1, Syed Kunal Abidi1
1Respiratory Epidemiology and Clinical Research Unit, Centre for Outcomes Research and Evaluation, Research Institute of the McGill University Health Centre, Montreal, Canada.
Insights
Diagnostic accuracy of coronavirus disease-2019 (covid-19) serological tests varies significantly. Enzyme-linked immunosorbent assays (ELISAs) show higher sensitivity than lateral flow immunoassays (LFIAs), especially for point-of-care use. More high-quality studies are needed.
Area of Science:
- Medical diagnostics
- Infectious disease epidemiology
Background:
- Accurate diagnostic tools are crucial for managing the coronavirus disease-2019 (covid-19) pandemic.
- Serological tests offer a potential method for detecting past or present infection by identifying antibodies.
- Evaluating the diagnostic accuracy of these tests is essential for their appropriate clinical application.
Purpose of the Study:
- To systematically review and meta-analyze the diagnostic accuracy of available serological tests for covid-19.
- To stratify accuracy by testing method (ELISA, LFIA, CLIA) and immunoglobulin class (IgG, IgM).
- To identify factors influencing test performance, such as time since symptom onset.
Main Methods:
- A systematic review and meta-analysis of studies published between January and April 2020.
- Inclusion of studies comparing covid-19 serological tests against viral culture or RT-PCR.
- Random effects bivariate meta-analyses were used to pool sensitivity and specificity data.
- Risk of bias was assessed using the QUADAS-2 tool.
Main Results:
- Forty studies involving 5016 references were included, with significant risk of bias noted in patient selection and test interpretation.
- Pooled sensitivity varied by method: ELISA (84.3%), LFIA (66.0%), and CLIA (97.8%). Specificities were generally high (96.6%-99.7%).
- Lateral flow immunoassays (LFIAs), potential point-of-care tests, exhibited lower pooled sensitivity compared to ELISAs and CLIAs.
- Sensitivity was substantially lower in the first week after symptom onset (13.4%-50.3%) compared to later stages (69.9%-98.9%).
Conclusions:
- Current evidence indicates significant variability in the diagnostic accuracy of covid-19 serological tests.
- The performance of lateral flow immunoassays (LFIAs) suggests they are not currently reliable for widespread point-of-care use.
- There is an urgent need for higher quality clinical studies to accurately assess diagnostic performance, particularly for tests intended for point-of-care applications.
Objective:
To determine the diagnostic accuracy of serological tests for coronavirus disease-2019 (covid-19).
Design:
Systematic review and meta-analysis.
Data Sources:
Medline, bioRxiv, and medRxiv from 1 January to 30 April 2020, using subject headings or subheadings combined with text words for the concepts of covid-19 and serological tests for covid-19.
Eligibility Criteria And Data Analysis:
Eligible studies measured sensitivity or specificity, or both of a covid-19 serological test compared with a reference standard of viral culture or reverse transcriptase polymerase chain reaction. Studies were excluded with fewer than five participants or samples. Risk of bias was assessed using quality assessment of diagnostic accuracy studies 2 (QUADAS-2). Pooled sensitivity and specificity were estimated using random effects bivariate meta-analyses.
Main Outcome Measures:
The primary outcome was overall sensitivity and specificity, stratified by method of serological testing (enzyme linked immunosorbent assays (ELISAs), lateral flow immunoassays (LFIAs), or chemiluminescent immunoassays (CLIAs)) and immunoglobulin class (IgG, IgM, or both). Secondary outcomes were stratum specific sensitivity and specificity within subgroups defined by study or participant characteristics, including time since symptom onset.
Results:
5016 references were identified and 40 studies included. 49 risk of bias assessments were carried out (one for each population and method evaluated). High risk of patient selection bias was found in 98% (48/49) of assessments and high or unclear risk of bias from performance or interpretation of the serological test in 73% (36/49). Only 10% (4/40) of studies included outpatients. Only two studies evaluated tests at the point of care. For each method of testing, pooled sensitivity and specificity were not associated with the immunoglobulin class measured. The pooled sensitivity of ELISAs measuring IgG or IgM was 84.3% (95% confidence interval 75.6% to 90.9%), of LFIAs was 66.0% (49.3% to 79.3%), and of CLIAs was 97.8% (46.2% to 100%). In all analyses, pooled sensitivity was lower for LFIAs, the potential point-of-care method. Pooled specificities ranged from 96.6% to 99.7%. Of the samples used for estimating specificity, 83% (10 465/12 547) were from populations tested before the epidemic or not suspected of having covid-19. Among LFIAs, pooled sensitivity of commercial kits (65.0%, 49.0% to 78.2%) was lower than that of non-commercial tests (88.2%, 83.6% to 91.3%). Heterogeneity was seen in all analyses. Sensitivity was higher at least three weeks after symptom onset (ranging from 69.9% to 98.9%) compared with within the first week (from 13.4% to 50.3%).
Conclusion:
Higher quality clinical studies assessing the diagnostic accuracy of serological tests for covid-19 are urgently needed. Currently, available evidence does not support the continued use of existing point-of-care serological tests.
Study Registration:
PROSPERO CRD42020179452.
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