Point-of-care testing for the detection of SARS-CoV-2: a systematic review and meta-analysis.
Eur Rev Med Pharmacol Sci
; 25(1): 503-517, 2021 Jan.
Article
en En
| MEDLINE
| ID: mdl-33506942
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 ANDMETHODS:
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.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Pruebas en el Punto de Atención
/
Prueba de COVID-19
/
SARS-CoV-2
/
COVID-19
Tipo de estudio:
Diagnostic_studies
/
Guideline
/
Prognostic_studies
/
Systematic_reviews
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Eur Rev Med Pharmacol Sci
Asunto de la revista:
FARMACOLOGIA
/
TOXICOLOGIA
Año:
2021
Tipo del documento:
Article
País de afiliación:
Corea del Sur