| Summary: | Binhua Dong,1,* Pengming Sun,1,2,* Guanyu Ruan,1 Weiyi Huang,1 Xiaodan Mao,1 Yafang Kang,1 Diling Pan,3 Fen Lin1 1Laboratory of Gynecologic Oncology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou 350001, Fujian, P.R. China; 2Department of Gynecology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou 350001, Fujian, P.R. China; 3Department of Pathology, Fujian Provincial Maternity and Children’s Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou 350001, Fujian, P.R. China *These authors contributed equally to this work 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® HR-HPV and cytology assays were enrolled. The viral loads of 1,396 HR-HPV-positive specimens confirmed by Cervista® 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 log10-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. Keywords: high risk, human papillomavirus, viral load, high-grade squamous intraepithelial lesion, BioPerfectus Multiplex Real-Time PCR
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