Eur Rev Med Pharmacol Sci 2021; 25 (1): 503-517

DOI: 10.26355/eurrev_202101_24422

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

S.H. Yoon, S. Yang, H. Cho, S. Eun, C.M. Koo, M.K. Kim

Department of Pediatrics, Severance Children’s Hospital, Yonsei University College of Medicine, Seoul, South Korea. YOONSH@yuhs.ac


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.

Free PDF Download

To cite this article

S.H. Yoon, S. Yang, H. Cho, S. Eun, C.M. Koo, M.K. Kim
Point-of-care testing for the detection of SARS-CoV-2: a systematic review and meta-analysis

Eur Rev Med Pharmacol Sci
Year: 2021
Vol. 25 - N. 1
Pages: 503-517
DOI: 10.26355/eurrev_202101_24422