Clinical verification REALQUALITY RQ-HPV HR Multiplex according to international guidelines for the detection of human papillomavirus
DOI:
https://doi.org/10.35997/unaciencia.v16i30.720Keywords:
Human Papilloma Virus (HPV), HPV DNA Test, Molecular Testing, Real-Time PCR, Human Papilloma Virus (HPV), HPV DNA Test, Molecular Testing, Real-Time PCRAbstract
The verification of a molecular test before their use in clinical practice testing is essential for providing a safe and useful service to both clinicians and patients, so it is the responsibility of each laboratory to determine and document that the claims of the assay are accurate, reproducible and sound. Although guidelines exist for how validation and verification studies may be approached for molecular assays, the specific details of the approach used by laboratories are rarely published in Colombia. This paper outlines the principles of verification of a molecular biology test, given the importance that a well-designed verification will define the performance characteristics of the assay and the possible results generated by it. The REALQUALITY RQ-HPV HR Multiplex Diagnostic Kit multiplex is a Real-Time PCR for the simultaneous detection and genotyping of 14 high-risk (HR) genotypes of HPV, including HPV16 and HPV18. Before its implementation in the laboratory, we carry out a verification process of the method, in order to confirm that the performance characteristics of the assay in the clinical laboratory. Using the CLSI MM-19 standard as a guide, we found a high sensitivity and specificity of this method.
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