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Introducción: La detección del virus SARS-CoV-2, agente causal de la COVID-19, es determinante para disminuir la propagación de la actual pandemia. Si bien el procedimiento de elección es la determinación del ácido nucleico del virus mediante la reacción en cadena de la polimerasa, también es necesario disponer de pruebas rápidas, con alta sensibilidad y precisión. Objetivo: Analizar la validez diagnóstica de un ensayo rápido de antígeno SARS-CoV-2, utilizado para la detección de la COVID-19 en el policlínico "5 de Septiembre" del municipio Playa. Material y Métodos: Se realizó un estudio analítico de corte transversal con 590 pacientes atendidos en la consulta de infecciones respiratorias agudas, en el período de enero a agosto de 2021. La determinación de antígeno SARS-CoV-2 se realizó con un ensayo rápido y la confirmación se hizo mediante la reacción en cadena de la polimerasa. Resultados: La prueba rápida de antígeno tuvo una elevada sensibilidad (98,19 %) y especificidad (92,39 %). La concordancia de los resultados obtenidos entre ambas pruebas fue elevada (0,868). Las sintomatologías más frecuentes reportadas, fueron, cefalea (51,69 %), fiebre (39,15 %), tos (37,16 %), pérdida del gusto/olfato (34,06 %) y rinorrea (30,16 %). Conclusiones: El ensayo rápido de antígeno del SARS-CoV-2 usado para la detección de la COVID-19 demostró validez y puede ser utilizado para el diagnóstico de la enfermedad. Las sintomatologías cefalea, fiebre, tos, pérdida del gusto/olfato y rinorrea fueron las más frecuentes, reportadas en más de 30 de los casos.
Introduction: The detection of the SARS-CoV-2 virus, the causal agent of COVID-19, is decisive to reduce the spread of the current pandemic. Although the procedure of choice is the determination of the nucleic acid of the virus using the polymerase chain reaction, the availability of rapid, highly sensitive, and accurate tests is also necessary. Objective: To analyze the diagnostic validity of a SARS-CoV-2 antigen rapid diagnostic test for the detection of COVID-19 in the "5 de Septiembre" Polyclinic in Playa municipality. Material and Methods: A cross-sectional analytical study was carried out on 590 patients seen in the acute respiratory infections consulting room in the period from January to August 2021. The detection of the SARS-CoV-2 antigen was performed using a rapid test and it was confirmed by polymerase chain reaction. Results: The rapid antigen test had a high sensitivity (98.19%) and specificity (92.39%). The concordance of the results obtained from both tests was high (0.868). The most frequent reported symptoms were headache (51.69%), fever (39.15%), cough (37.16%), loss of taste/smell (34.06%), and runny nose (30.16%). Conclusions: The SARS-CoV-2 antigen rapid diagnostic test used for the detection of COVID-19 is valid and can be used in the diagnosis of the disease. Symptoms such as headache, fever, cough, loss of taste/smell, and runny nose were the most frequently reported in more than 30% of cases.
RESUMEN
ABSTRACT Introduction: In the current standard of care (SoC) RT-PCR method for COVID-19, the patient's swab was extracted in viral transport media (VTM). For the PanbioTM COVID-19 Ag Rapid Test, the patient swab is flushed out in extraction buffer, of which a small fraction is used for testing, leaving more than half the sample unused. This study was designed to show that RT-PCR results from the residual sample of the PanbioTM COVID-19 Ag Rapid Test (called Novel RT-PCR) are not worse than the SoC RT-PCR result. Methods: The study was performed using (1) dilution series of five patient samples, and (2) 413 patient samples comparing SOC versus Novel RT-PCR results. Results: For the dilution series samples, all tested positive by both methods. The bias between Ct values of Novel RT-PCR and SoC RT-PCR did not exceed 3.00 Ct using primers N1 and N2. A total of 413 COVID symptomatic patients seeking COVID testing were tested, of which 89 patients tested positive and 324 tested negative with SoC RT-PCR. In 324 patients who tested negative with SoC RT-PCR, 323 tested negative with Novel RT-PCR, and one (1) tested positive. Out of 89 who tested positive with SoC RT-PCR, 80 tested positive with the Novel RT-PCR, and nine patients showed a negative test result. The Overall Percent Agreement for the 413 valid patient sample pairs was 97.5 [95% CI 97 to 98]. Conclusion: The study demonstrated that the performance of the Novel RT-PCR method is acceptable compared to the SoC RT-PCR method and can be a useful tool to perform RTPCR without the need for new swab collections.