Optimización del control interno de calidad de RT-PCR en tiempo real para detección cualitativa de SARS-CoV-2

Giancarlo Torres-Gamarra

doi:10.35434/rcmhnaaa.2023.161.1657

Authors

Giancarlo Torres-Gamarra Escuela Académico Profesional de Tecnología Médica, Facultad de Ciencias de la Salud, Universidad Nacional Hermilio Valdizán (UNHEVAL). Huánuco-Perú

DOI:

https://doi.org/10.35434/rcmhnaaa.2023.161.1657

Keywords:

Optimization, Internal quality control, Real-time RT-PCR, SARS-CoV-2

Abstract

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.

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Author Biography

Giancarlo Torres-Gamarra, Escuela Académico Profesional de Tecnología Médica, Facultad de Ciencias de la Salud, Universidad Nacional Hermilio Valdizán (UNHEVAL). Huánuco-Perú

1. Tecnólogo médico

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