Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
Data
2020
Autores
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
Journal Title
Journal ISSN
Volume Title
Publisher
BMJ
Resumo
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.
Study registration
PROSPERO CRD42020179452.
Description
Palavras-chave
Antibodies, Viral / blood, Betacoronavirus, COVID-19, COVID-19 Testing, Clinical Laboratory Techniques / standards*, Coronavirus Infections / diagnosis*, Enzyme-Linked Immunosorbent Assay, Humans, Immunoassay, Luminescent Measurements, Pandemics, Pneumonia, Viral / diagnosis*, SARS-CoV-2, Sensitivity and Specificity, Serologic Tests / standards*.
Citação
Lisboa Bastos M, Tavaziva G, Abidi SK, Campbell JR, Haraoui LP, Johnston JC, Lan Z, Law S, MacLean E, Trajman A, Menzies D, Benedetti A, Ahmad Khan F. Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis. BMJ. 2020 Jul 1;370:m2516. doi: 10.1136/bmj.m2516.