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Diagnostic accuracy of serological tests for covid-19 : systematic review and meta-analysis Bastos, Mayara Lisboa; Tavaziva, Gamuchirai; Abidi, Syed Kunal; Campbell, Jonathon R.; Haraoui, Louis-Patrick; Johnston, James C.; Lan, Zhiyi; Law, Stephanie; MacLean, Emily; Trajman, Anete; Menzies, Dick; Benedetti, Andrea; Khan, Faiz Ahmad
Abstract
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% (10465/12547) 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.
Item Metadata
Title |
Diagnostic accuracy of serological tests for covid-19 : systematic review and meta-analysis
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Creator | |
Publisher |
BMJ
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Date Issued |
2020-07-01
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Description |
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% (10465/12547) 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.
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Genre | |
Type | |
Language |
eng
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Date Available |
2021-06-08
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Provider |
Vancouver : University of British Columbia Library
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Rights |
Attribution-NonCommercial 4.0 International
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DOI |
10.14288/1.0398285
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URI | |
Affiliation | |
Citation |
Lisboa Bastos Mayara, Tavaziva Gamuchirai, Abidi Syed Kunal, Campbell Jonathon R, Haraoui Louis-Patrick, Johnston James C et al. Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis BMJ 2020; 370 :m2516
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Publisher DOI |
10.1136/bmj.m2516
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Peer Review Status |
Reviewed
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Scholarly Level |
Faculty; Researcher; Postdoctoral; Graduate
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Copyright Holder |
Authors
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Rights URI | |
Aggregated Source Repository |
DSpace
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Item Media
Item Citations and Data
Rights
Attribution-NonCommercial 4.0 International