Verification in Scope A of an RT-PCR Method for the Detection of the SARS-CoV-2 Genome

Molecular biology is the 'Gold Standard' for diagnosing Covid 19 infection. For good analytical performance, evaluations are necessary in accordance with the normative requirements. The objective of study is to determine the suitability of the method tests at the Microbiology Laboratory of CHU Ibn Rochd in Casablanca. This is a prospective study conducted over a period of 6 months ans described the verification of method scope A for RT-PCR in the detection of RNA virus. RNA extraction from a nasopharyngeal sample was performed using magnetic bead technology on the extraction automated system. Amplification was carried out using a moccocan kit on a thermocycler. Results interpretation was based on the manufacturer's recommendations and those of relevant scientific societies. The results demonstrated good reliability and method compliance, with a coefficient of variation of less than 5%. Reproducibility showed consistent results. Regarding accuracy, a comparison of results during external quality assessment indicated satisfactory precision compliance. Tests for inter-sample contamination revealed no contamination. Method comparison, performed with a second thermocycler, showed concordance of results. Molecular diagnostics have become essential in many fields. Therefore, mastering the performance and limitations of these tests is crucial for aiding in result interpretation and clinical management of patients.