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  • Title: Clinical Performance Evaluation of a High-Risk Human Papillomavirus Genotyping Test "Clinichip HPV" Using Cervical Scrape Specimens.
    Author: Yamada H, Tabe Y, Ishii K, Terao Y, Yamashita Y, Horii T, Takeda S, Ohsaka A.
    Journal: Clin Lab; 2015; 61(7):851-5. PubMed ID: 26299088.
    Abstract:
    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.
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