Real-time RT-PCR internal quality control optimization for qualitative detection of SARS-CoV-2

• Autor: Torres-Gamarra, Giancarlo
• Formato: artículo
• Fecha de Publicación: 2023
• Institución: Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo
• Repositorio: Revista del Cuerpo Médico Hospital Nacional Almanzor Aguinaga Asenjo
• Lenguaje: español
• OAI Identifier: oai:cmhnaaa_ojs_cmhnaaa.cmhnaaa.org.pe:article/1657
• Enlace del recurso: https://cmhnaaa.org.pe/ojs/index.php/rcmhnaaa/article/view/1657
• Nivel de acceso: acceso abierto
• Materia: Optimización; Control interno de calidad; RT-PCR en tiempo real; SARS-CoV-2; Optimization; Internal quality control; Real-time RT-PCR

Objective: To optimize the internal quality control of real-time RT-PCR for the qualitative detection of SARS-CoV-2, using the Cq values ​​of negative and positive controls. Material and method: Prospective-longitudinal study. The sample consisted of 143 Cq values ​​for the negative aliquot and extraction controls, as well as for the positive control. The normal distribution of Cq values ​​was analyzed using the Anderson-Darling (AD) test and randomness tests were applied. Control limits were calculated from 51 Cq values, and then, using control charts, to monitor 92 Cq values ​​obtained from November 2020 to March 2021. Lot acceptance and Cpk indices were evaluated as optimization indicators. The calculations were made with the Minitab program. Results: The batches of Cq values ​​were accepted and Cpk indices higher than 1.33 were obtained for the three types of control. Discussion: There are no published studies that apply statistical quality control to the qualitative detection of SARS-CoV-2. Conclusions: It is possible to use the Cq values ​​of the controls to optimize the internal quality control of real-time RT-PCR for qualitative detection of SARS-CoV-2, as if it were a quantitative technique.