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Point-of-care testing for the detection of SARS-CoV-2: a systematic review and meta-analysis

Authors
 S H Yoon  ;  S Yang  ;  H Cho  ;  S Eun  ;  C M Koo  ;  M K Kim 
Citation
 EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES, Vol.25(1) : 503-517, 2021-01 
Journal Title
 EUROPEAN REVIEW FOR MEDICAL AND PHARMACOLOGICAL SCIENCES 
ISSN
 1128-3602 
Issue Date
2021-01
MeSH
COVID-19 / diagnosis* ; COVID-19 Testing / methods* ; COVID-19 Testing / standards* ; Clinical Laboratory Techniques / methods ; Clinical Laboratory Techniques / standards ; Humans ; Point-of-Care Testing / standards* ; Quality Assurance, Health Care ; SARS-CoV-2 / genetics ; SARS-CoV-2 / isolation & purification* ; Sensitivity and Specificity ; United States ; United States Food and Drug Administration
Abstract
Objective: To evaluate the diagnostic accuracy of the Food and Drug Administration Emergency Use Authorization (FDA-EUA) authorized point-of-care tests (POCTs) for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Materials and methods: A systematic literature search was conducted using the PubMed, Embase, and Web of Science databases for articles published till August 10, 2020. We included studies providing information regarding diagnostic test accuracy of FDA-EUA POCTs for SARS-CoV-2 detection. The methodologic quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool. The review protocol is registered in the International Prospective Register of Systematic Reviews (protocol number CRD42020202248). Results: We included 26 studies describing a total of 3242 samples. The summary sensitivity and specificity were 0.94 [95% confidence interval (CI): 0.88-0.97] and 1.00 (95% CI: 0.99-1.00), respectively. The area under the summary receiver operating characteristic curve was 1.00 (95% CI: 0.99-1.00). A pooled analysis based on the index test revealed a summary sensitivity and specificity of Cepheid Xpert Xpress SARS-CoV-2 [0.99 (95% CI: 0.97-1.00) and 0.99 (95% CI: 0.94-1.00, respectively)] and ID NOW COVID-19 [0.78 (95% CI: 0.74-0.82) and 1.00 (95% CI: 0.98-1.00), respectively]. Conclusions: FDA-EUA POCTs, especially molecular assays, have high sensitivity, specificity, and overall diagnostic accuracy for detecting SARS-CoV-2. If approved, FDA-EUA POCTs can provide a rapid and practical way to identify infected individuals early on and help to limit the strain on the healthcare system. However, more high-quality clinical data are required to support our results.
Files in This Item:
T202100249.pdf Download
DOI
10.26355/eurrev_202101_24422
Appears in Collections:
1. College of Medicine (의과대학) > Others (기타) > 1. Journal Papers
Yonsei Authors
Koo, Chung Mo(구청모)
Kim, Moon Kyu(김문규) ORCID logo https://orcid.org/0000-0001-6186-3991
Yoon, Seo Hee(윤서희) ORCID logo https://orcid.org/0000-0002-8361-9815
Eun, So Hyun(은소현)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/182031
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