Clinical Performance Evaluation of a High-Risk Human Papillomavirus Genotyping Test "Clinichip HPV" Using Cervical Scrape Specimens.

Abstract

Persistent infection with high-risk human papillomavirus (HPV) is closely associated with cervical cancer development. In this study, the performance of the Clinichip HPV genotyping assay as a screening laboratory test for high-risk HPV infection was evaluated. The genotypes of 74 cervical scrape specimens were tested using the Clinichip HPV assay and a conventionally employed HPV polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) assay. PCR sequencing was performed in cases with discrepant results between the Clinichip HPV test and PCR-RFLP. Genotyping using the Clinichip HPV assay and PCR-RFLP method resulted in 27% disagreement. PCR sequence results exhibited 79% and 21% consistency with the Clinichip HPV assay and PCR-RFLP method, respectively. Multiple infections were detected in 24.3% and 12.2% of the tested cases using the Clinichip HPV assay and PCR-RFLP method, respectively. The genotyping performance of the Clinichip HPV showed strong concordance with PCR sequencing, although this rate was partially diminished in cases with multiple HPV infections. The Clinichip HPV represents a suitable laboratory test for the clinical screening of high-risk HPV infections.