Type-specific high-risk human papillomavirus viral load as a viable triage indicator for high-grade squamous intraepithelial lesion: a nested case-control study

Purpose: Currently, the associations between type-specific high-risk human papillomavirus (HR-HPV) viral loads and cervical lesions are still inconsistent. We aimed to assess the type-specific HR-HPV viral load as a risk triage indicator for development of high-grade squamous intraepithelial lesion or worse (>= HSIL). Patients and methods: A total of 19,446 women who underwent primary screening for cervical cancer using Cervista (R) HR-HPV and cytology assays were enrolled. The viral loads of 1,396 HR-HPV-positive specimens confirmed by Cervista (R) assay were detected by BioPerfectus Multiplex Real-Time PCR assay. The correlation between viral loads and cervical lesions was analyzed. The optimal cutoffs of individual HR-HPV viral loads used to predict >= HSIL were determined from the receiver operating characteristic curve. A logistic regression model was used to analyze the relationship between covariates and the probability of >= HSIL. Results: The viral loads of HPV-16, -31, -33, -52, and -58 were positively correlated with the severity of the cervical lesion, which was significantly elevated in patients with >= HSIL, whereas those of HPV-18, -45, -56, -59, and other types were not. The optimal cutoffs of the log(10)-transformed viral loads for HPV-16, -31, -33, -52, and -58 in identifying >= HSIL were 4.26, 4.46, 4.48, 4.36, and 4.26 copies per 10,000 cells, respectively. Furthermore, multivariate analysis indicated that type-specific viral loads of HPV-16, -31, -33, -52, and -58 exceeding the cutoffs could be independent risk factors for the incidence of >= HSIL. Conclusion: The BioPerfectus Multiplex Real-Time PCR viral load assay provides viable triage for >= HSIL when using appropriate cutoff levels.