In:
PLOS Medicine, Public Library of Science (PLoS), Vol. 18, No. 8 ( 2021-8-12), p. e1003735-
Abstract:
SARS-CoV-2 antigen rapid diagnostic tests (Ag-RDTs) are increasingly being integrated in testing strategies around the world. Studies of the Ag-RDTs have shown variable performance. In this systematic review and meta-analysis, we assessed the clinical accuracy (sensitivity and specificity) of commercially available Ag-RDTs. Methods and findings We registered the review on PROSPERO (registration number: CRD42020225140). We systematically searched multiple databases (PubMed, Web of Science Core Collection, medRvix, bioRvix, and FIND) for publications evaluating the accuracy of Ag-RDTs for SARS-CoV-2 up until 30 April 2021. Descriptive analyses of all studies were performed, and when more than 4 studies were available, a random-effects meta-analysis was used to estimate pooled sensitivity and specificity in comparison to reverse transcription polymerase chain reaction (RT-PCR) testing. We assessed heterogeneity by subgroup analyses, and rated study quality and risk of bias using the QUADAS-2 assessment tool. From a total of 14,254 articles, we included 133 analytical and clinical studies resulting in 214 clinical accuracy datasets with 112,323 samples. Across all meta-analyzed samples, the pooled Ag-RDT sensitivity and specificity were 71.2% (95% CI 68.2% to 74.0%) and 98.9% (95% CI 98.6% to 99.1%), respectively. Sensitivity increased to 76.3% (95% CI 73.1% to 79.2%) if analysis was restricted to studies that followed the Ag-RDT manufacturers’ instructions. LumiraDx showed the highest sensitivity, with 88.2% (95% CI 59.0% to 97.5%). Of instrument-free Ag-RDTs, Standard Q nasal performed best, with 80.2% sensitivity (95% CI 70.3% to 87.4%). Across all Ag-RDTs, sensitivity was markedly better on samples with lower RT-PCR cycle threshold (Ct) values, i.e., 〈 20 (96.5%, 95% CI 92.6% to 98.4%) and 〈 25 (95.8%, 95% CI 92.3% to 97.8%), in comparison to those with Ct ≥ 25 (50.7%, 95% CI 35.6% to 65.8%) and ≥30 (20.9%, 95% CI 12.5% to 32.8%). Testing in the first week from symptom onset resulted in substantially higher sensitivity (83.8%, 95% CI 76.3% to 89.2%) compared to testing after 1 week (61.5%, 95% CI 52.2% to 70.0%). The best Ag-RDT sensitivity was found with anterior nasal sampling (75.5%, 95% CI 70.4% to 79.9%), in comparison to other sample types (e.g., nasopharyngeal, 71.6%, 95% CI 68.1% to 74.9%), although CIs were overlapping. Concerns of bias were raised across all datasets, and financial support from the manufacturer was reported in 24.1% of datasets. Our analysis was limited by the included studies’ heterogeneity in design and reporting. Conclusions In this study we found that Ag-RDTs detect the vast majority of SARS-CoV-2-infected persons within the first week of symptom onset and those with high viral load. Thus, they can have high utility for diagnostic purposes in the early phase of disease, making them a valuable tool to fight the spread of SARS-CoV-2. Standardization in conduct and reporting of clinical accuracy studies would improve comparability and use of data.
Type of Medium:
Online Resource
ISSN:
1549-1676
DOI:
10.1371/journal.pmed.1003735
DOI:
10.1371/journal.pmed.1003735.g001
DOI:
10.1371/journal.pmed.1003735.g002
DOI:
10.1371/journal.pmed.1003735.g003
DOI:
10.1371/journal.pmed.1003735.g004
DOI:
10.1371/journal.pmed.1003735.g005
DOI:
10.1371/journal.pmed.1003735.g006
DOI:
10.1371/journal.pmed.1003735.g007
DOI:
10.1371/journal.pmed.1003735.g008
DOI:
10.1371/journal.pmed.1003735.g009
DOI:
10.1371/journal.pmed.1003735.g010
DOI:
10.1371/journal.pmed.1003735.t001
DOI:
10.1371/journal.pmed.1003735.t002
DOI:
10.1371/journal.pmed.1003735.s001
DOI:
10.1371/journal.pmed.1003735.s002
DOI:
10.1371/journal.pmed.1003735.s003
DOI:
10.1371/journal.pmed.1003735.s004
DOI:
10.1371/journal.pmed.1003735.s005
DOI:
10.1371/journal.pmed.1003735.s006
DOI:
10.1371/journal.pmed.1003735.s007
DOI:
10.1371/journal.pmed.1003735.s008
DOI:
10.1371/journal.pmed.1003735.s009
DOI:
10.1371/journal.pmed.1003735.s010
DOI:
10.1371/journal.pmed.1003735.s011
DOI:
10.1371/journal.pmed.1003735.s012
DOI:
10.1371/journal.pmed.1003735.s013
DOI:
10.1371/journal.pmed.1003735.s014
DOI:
10.1371/journal.pmed.1003735.s015
DOI:
10.1371/journal.pmed.1003735.s016
DOI:
10.1371/journal.pmed.1003735.s017
DOI:
10.1371/journal.pmed.1003735.s018
DOI:
10.1371/journal.pmed.1003735.r001
DOI:
10.1371/journal.pmed.1003735.r002
DOI:
10.1371/journal.pmed.1003735.r003
DOI:
10.1371/journal.pmed.1003735.r004
DOI:
10.1371/journal.pmed.1003735.r005
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2021
detail.hit.zdb_id:
2164823-2
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