Comparación analítica y clínica de dos pruebas diagnósticas moleculares para la detección de SARS COV2
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Fecha
2022
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Universidad de Guayaquil. Facultad de Ciencias Médicas. Escuela de Graduados
Resumen
ANTECEDENTE: La enfermedad ocasionada por el nuevo Coronavirus SARS de tipo dos
impactó el mundo entero a comienzos del año 2020, fue detectada por primera vez en Wuhan
China en diciembre de 2019 y culminó con la declaración de una pandemia en marzo 11 de 2020.
La reacción en cadena de la polimerasa con transcriptasa inversa en tiempo real (RT-PCR) es el
estándar de oro para el diagnóstico de SARS COV2 por su rapidez, sensibilidad y especificidad
al informar sobre la infección activa por coronavirus (Creager, 2020). OBJETIVO: Comparar
el desempeño para detectar SARS CoV2 de una PCR multiplex, con el de un método para
diagnóstico in vitro basado en PCR cuantitativa. METODOLOGÍA: Se realizó un estudio
descriptivo, retrospectivo de corte transversal. Se llevó a cabo en el Laboratorio de Biología
Molecular del Instituto Oncológico Nacional SOLCA, Guayaquil – Ecuador, se tomó como
universo todas las muestras adquiridas desde enero a agosto de 2021 en que se hayan realizado
simultáneamente las dos pruebas moleculares. Para este estudio se revisó los resultados
moleculares y clínicos registrados en el sistema INTRANET, los cuales fueron tabulados en una
planilla de Excel y los resultados fueron analizados mediante una plataforma estadística SPSS.
RESULTADOS: Se recuperó un total de 148 casos testeados, de los cuales en 23/148 (15.5 %)
pacientes se detectó ARN viral de SARS COV2 y en 125 /148 (84.5 %) pacientes no se detectó
ARN viral de SARS COV2. El PANEL RESPIRATORIO BioFire® 2.1 detectó SARS COV2 en
16 (10.8%) muestras (verdaderos positivos); 3 (2%) muestras no detectadas (falso negativo), 4
(2.7%) casos (falso positivo) y en 125 (84.5%) casos no se detectó (verdaderos negativos). Se
determinó una sensibilidad del 84% para el PANEL RESPIRATORIO BioFire® 2.1 y una
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especificidad del 97%. CONCLUSIONES: La sensibilidad de la PCR multiplex resultó menor
comparada con la PCR-
RT cuantitativa, la especificidad resultó similar en las dos pruebas.
PALABRAS CLAVE: Diagnóstico molecular, PCR-RT, panel respiratorio BioFire® 2.1, SARS
COV2
BACKGROUND: The disease caused by the new type 2 SARS Coronavirus impacted the entire world at the beginning of the year 2020, was first detected in Wuhan China in December 2019 and culminated in the declaration of a pandemic on March 11, 2020. The reaction in Real-time reverse transcriptase polymerase chain reaction (RT-PCR) is the gold standard for SARS COV2 diagnosis due to its speed, sensitivity, and specificity in reporting active coronavirus infection. (Creager, 2020). OBJECTIVE: To compare the performance to detect SARS CoV2 of a multiplex PCR, with that of an in vitro diagnostic method based on quantitative PCR. METHODOLOGY: A descriptive, retrospective cross-sectional study was carried out. It was carried out in the Molecular Biology Laboratory of the SOLCA National Oncology Institute, Guayaquil - Ecuador, all the samples acquired from January to August 2021 in which the two molecular tests were performed simultaneously were taken as a universe. For this study, the molecular and clinical results recorded in the INTRANET system were reviewed, which were tabulated in an Excel spreadsheet and the results were analyzed using a SPSS statistical platform. RESULTS: A total of 148 tested cases were recovered, of which SARS COV2 viral RNA was 18 detected in 23/148 (15.5%) patients and SARS COV2 viral RNA was not detected in 125/148 (84.5%) patients. The BioFire® 2.1 RESPIRATORY PANEL detected SARS COV2 in 16 (10.8%) samples (true positives); 3 (2%) samples were not detected (false negative), 4 (2.7%) cases (false positive) and in 125 (84.5%) cases it was not detected (true negative). A sensitivity of 84% was determined for the BioFire® 2.1 RESPIRATORY PANEL and a specificity of 97%. CONCLUSIONS: The sensitivity of the multiplex PCR was lower compared to the QUANTITATIVE RT-PCR, the specificity was similar in the two tests. KEY WORDS: Molecular diagnosis, RT-PCR, BioFire® 2.1 respiratory panel, SARS COV2
BACKGROUND: The disease caused by the new type 2 SARS Coronavirus impacted the entire world at the beginning of the year 2020, was first detected in Wuhan China in December 2019 and culminated in the declaration of a pandemic on March 11, 2020. The reaction in Real-time reverse transcriptase polymerase chain reaction (RT-PCR) is the gold standard for SARS COV2 diagnosis due to its speed, sensitivity, and specificity in reporting active coronavirus infection. (Creager, 2020). OBJECTIVE: To compare the performance to detect SARS CoV2 of a multiplex PCR, with that of an in vitro diagnostic method based on quantitative PCR. METHODOLOGY: A descriptive, retrospective cross-sectional study was carried out. It was carried out in the Molecular Biology Laboratory of the SOLCA National Oncology Institute, Guayaquil - Ecuador, all the samples acquired from January to August 2021 in which the two molecular tests were performed simultaneously were taken as a universe. For this study, the molecular and clinical results recorded in the INTRANET system were reviewed, which were tabulated in an Excel spreadsheet and the results were analyzed using a SPSS statistical platform. RESULTS: A total of 148 tested cases were recovered, of which SARS COV2 viral RNA was 18 detected in 23/148 (15.5%) patients and SARS COV2 viral RNA was not detected in 125/148 (84.5%) patients. The BioFire® 2.1 RESPIRATORY PANEL detected SARS COV2 in 16 (10.8%) samples (true positives); 3 (2%) samples were not detected (false negative), 4 (2.7%) cases (false positive) and in 125 (84.5%) cases it was not detected (true negative). A sensitivity of 84% was determined for the BioFire® 2.1 RESPIRATORY PANEL and a specificity of 97%. CONCLUSIONS: The sensitivity of the multiplex PCR was lower compared to the QUANTITATIVE RT-PCR, the specificity was similar in the two tests. KEY WORDS: Molecular diagnosis, RT-PCR, BioFire® 2.1 respiratory panel, SARS COV2
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Técnicas de Diagnóstico Molecular, Síndrome Respiratorio Agudo Grave, COVID-19, Estudio comparativo, Epidemiología descriptiva, Estudios retrospectivos, Hospital SOLCA de Guayaquil, Cantón Guayaquil, Ecuador