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Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis

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 t...

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Autores principales: Lisboa Bastos, Mayara, 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, Ahmad Khan, Faiz
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7327913/
https://www.ncbi.nlm.nih.gov/pubmed/32611558
http://dx.doi.org/10.1136/bmj.m2516
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author Lisboa Bastos, Mayara
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
Ahmad Khan, Faiz
author_facet Lisboa Bastos, Mayara
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
Ahmad Khan, Faiz
author_sort Lisboa Bastos, Mayara
collection PubMed
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% (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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spelling pubmed-73279132020-07-02 Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis Lisboa Bastos, Mayara 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 Ahmad Khan, Faiz BMJ Research 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. BMJ Publishing Group Ltd. 2020-07-01 /pmc/articles/PMC7327913/ /pubmed/32611558 http://dx.doi.org/10.1136/bmj.m2516 Text en © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Research
Lisboa Bastos, Mayara
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
Ahmad Khan, Faiz
Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
title Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
title_full Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
title_fullStr Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
title_full_unstemmed Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
title_short Diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
title_sort diagnostic accuracy of serological tests for covid-19: systematic review and meta-analysis
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7327913/
https://www.ncbi.nlm.nih.gov/pubmed/32611558
http://dx.doi.org/10.1136/bmj.m2516
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