Rendimiento diagnóstico de un sistema molecularde uso en el punto de atención para la detección de SARS-CoV-2 en Perú

Zully M. Puyén; Roger Araujo-Castillo; Jorge Giraldo; Karina Gutierrez; Nancy Rojas-Serrano

doi:10.17843/rpmesp.2024.411.13046

Authors

Zully M. Puyén Instituto Nacional de Salud, Lima, Perú. Escuela de Medicina, Universidad Peruana de Ciencias Aplicadas, Lima, Perú. https://orcid.org/0000-0002-5068-0986
Roger Araujo-Castillo Instituto Nacional de Salud, Lima, Perú. https://orcid.org/0000-0002-3740-1962
Jorge Giraldo Instituto Nacional de Salud, Lima, Perú https://orcid.org/0000-0001-7668-1824
Karina Gutierrez Instituto Nacional de Salud, Lima, Perú https://orcid.org/0009-0009-5516-919X
Nancy Rojas-Serrano Instituto Nacional de Salud, Lima, Perú https://orcid.org/0000-0002-3194-8043

DOI:

https://doi.org/10.17843/rpmesp.2024.411.13046

Keywords:

SARS-CoV-2, COVID-19, Molecular Diagnostic Techniques, PCR, Sensitivity and Specificity, Peru

Abstract

The present study assessed the diagnostic performance of the Xpert®Xpress SARS-CoV-2 test in comparison with the Charité protocol real-time RT PCR for the detection of SARS-CoV-2 in Peruvian patients. This was a diagnostic test study that included 100 nasal and pharyngeal swab samples. We obtained an overall concordance of 98.70% (95%CI: 92.98-99.97), with a kappa coefficient of 0.97 (95%CI: 0.86-1.00) and sensitivity and relative specificity rates of 100% and 96.15%, respectively. Additionally, the percentage of the area under the ROC curve was 98.08% in both cases, and an analytical specificity rate of 100% was obtained for the different respiratory viruses evaluated. In conclusion, the Xpert®Xpress SARS-CoV-2 test, by using nasal and pharyngeal swab samples, was highly sensitive and specific, and the kappa coefficient showed an excellent correlation when compared to the reference test.

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