Comparison of the performance in detection of HPV infections between the high‐risk HPV genotyping real time PCR and the PCR‐reverse dot blot assays

A new multiplex real‐time PCR assay, the high‐risk HPV genotyping real time PCR assay (HR HPV RT‐PCR), has been developed to detect 15 high‐risk HPV types with respective viral loads. In this report, a total of 684 cervical specimens from women diagnosed with vaginitis were assessed by the HR HPV RT‐PCR and the PCR reaction and reverse dot blot (PCR‐RDB) assays, using a PCR‐sequencing method as a reference standard. A total coincidence of 97.7% between the HR HPV RT PCR and the PCR‐RDB assays was determined with a Kappa value of 0.953. The HR HPV RT PCR assay had sensitivity, specificity, and concordance rates (accuracy) of 99.7%, 99.7%, and 99.7%, respectively, as confirmed by PCR‐sequencing, while the PCR‐RDB assay had respective rates of 98.8%, 97.1%, and 98.0%. The overall rate of HPV infection, determined by PCR‐sequencing, in women diagnosed with vaginitis was 49.85%, including 36.26% of single infection and 13.6% of multiple infections. The most common infections among the 15 high‐risk HPV types in women diagnosed with vaginitis were HPV‐52, HPV‐16, and HPV‐58, with a total detection rate of 10.23%, 7.75%, and 5.85%, respectively. We conclude that the HR HPV RT PCR assay exhibits better clinical performance than the PCR‐RDB assay, and is an ideal alternative method for HPV genotyping. In addition, the HR HPV RT PCR assay provides HPV DNA viral loads, and could serve as a quantitative marker in the diagnosis and treatment of single and multiple HPV infections.