Performance of DiaRD-HPV Rt-PCR Kit for Detection of High-Risk Human Papilloma Virus Genotypes: A Preliminary Study

Objectives: Rapid detection and identification of high-risk human papillomavirus (hrHPV) genotypes in cervical specimens has a crucial importance for management of patients. In this study, we evaluated the performance of the novel DiaRD-HPV Rt-PCR kit developed for screening HPV in cervical samples and identifying hrHPV types 16 and 18. Materials and Methods: The performance of the novel DiaRD-HPV Rt-PCR kit was tested on a total of 243 clinical samples, including 65 HPV positive (genotype 16, n=23; genotype 18, n=2; other genotype, n=40) and 178 HPV negative samples previously tested with the QIAscreen HPV PCR test kit. DNA was isolated from cervical specimens in PreservCyt transport medium using the Diarex Viral DNA/RNA extraction kit. Multiplex PCR was performed following the DiaRD-HPV Rt-PCR kit protocol. Results: The results of the novel kit were compared to those of the QIAscreen HPV PCR test kit using a comparator test. Of the 65 samples that were positive with the comparator kit, 62 (95.4%) were also positive with the novel kit. All 178 HPV DNA negative samples were also negative with the novel kit. The sensitivity, specificity, and accuracy of the novel kit were 95.4%, ≥99.9%, and 98.8%, respectively. According to the cycle threshold (Ct) values determined in the reproducibility studies, the intra-assay and inter-assay coefficients of variations (CVs) were less than 1%. Conclusion: The high concordance between the results of the novel kit and comparator kit supports the use of the DiaRD HPV Rt-PCR kit in clinical samples.