Abstract
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Clinical Performance Evaluation of a High-Risk Human Papillomavirus Genotyping Test “Clinichip HPV” Using Cervical Scrape Specimens
by Hiromi Yamada, Yoko Tabe, Kiyoshi Ishii, Yasuhisa Terao, Yohei Yamashita, Takashi Horii, Satoru Takeda, Akimichi Ohsaka
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Background: 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.
Methods: 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.
Results: 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.
Conclusions: 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.
DOI: 10.7754/Clin.Lab.2015.141015
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