Abstract:Objective To evaluate the clinical application performance of marketed commercial high-risk human papillomavirus (HPV) DNA (genotype) diagnostic kits based on real-time fluorescent quantitative PCR method by testing normal population samples and cervical cancer samples. Methods Two kinds of HPV diagnostic kits (reagents A and B) based on fluorescent quantitative PCR were separately used to detect HPV DNA in 1,000 physical examination samples, 48 cervical squamous cell carcinoma samples and 18 cervical adenocarcinoma samples, the results were compared and the clinical application performances of the two reagents were evaluated. Results The positive rates of the physical examination samples detected by reagents A and B were 18.5% and 16.5% respectively. The positive, negative and total coincidence rates of 14 kinds of HPV genotypes were 97.57%, 98.78% and 98.58% respectively. The positive rates of 48 cervical squamous cell carcinoma tissue samples detected by reagents A and B were 100% and 95.83% respectively, of which HPV types 16 (66.7%), 58 (14.6%) and 18(10.4%) accounted for a higher proportion. The positive rates of 18 cervical adenocarcinoma tissue samples detected by reagents A and B were 83.33% and 77.78% respectively, of which HPV types 16 (50%), 18 (27.7%) and 51 (11.1%) accounted for a higher proportion. The comparison results revealed that the positive rates of cervical squamous cell carcinoma and adenocarcinoma tissue samples detected by reagent A were higher than those detected by reagent B. Conclusions A comparison of the detection results indicates that the two reagents are in good consistency. Reagent A shows a lower detection limit and better detection performance, it is more suitable for the early detection and screening of cervical lesions in population, with high clinical application value.
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