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

Torres-Gamarra G. · Revista del Cuerpo Medico Hospital Nacional Almanzor Aguinaga Asenjo (2023) · DOI: 10.35434/rcmhnaaa.2023.161.1657

Resumen

Objetive: 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.

Instituciones: Universidad Nacional Hermilio Valdizán