An evaluation of a novel single tube method for extended genotyping of Human Papillomavirus

Ramya Bhatia, Itziar Serrano, Holli Wennington, Cat Graham, Heather Cubie, E Boland, G Fu, Kate Cuschieri

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The use of high-risk HPV testing for surveillance and clinical applications is increasing globally and it is important that tests are evaluated to ensure they are fit for purpose. In this study, the performance of a new HPV genotyping test -The Papilloplex® HR-HPV test- was compared to two well established genotyping tests. Preliminary clinical performance was also ascertained for the detection of CIN2+ in a disease-enriched retrospective cohort.
Methods: A panel of 500 cervical LBC samples with known clinical outcomes were tested by the Papilloplex® HR-HPV test. Analytical concordance was compared to two assays: Linear Array HPV Genotyping Test and Optiplex HPV Genotyping Test. Initial clinical performance for the detection for CIN2+ samples was performed and compared to that of two clinically validated HPV tests: the RealTime High Risk HPV test and Hybrid Capture 2 HPV Test.
Results: High agreement for HR-HPV was observed between the Papilloplex and LA and Optiplex HPV tests (97% and 95% respectively); with Kappa for HPV 16 and 18 being 0.90 and 0.81 compared to the LA and 0.70 and 0.82 compared to Optiplex. The sensitivity, specificity, PPV and NPV of Papilloplex for detection of CIN2+was 92%, 54%, 33% and 96% respectively and was very similar to that observed with RealTime and HC2.
Conclusion: Papilloplex HR-HPV test shows similar analytical performance to two HPV genotyping tests at the level of HR-HPV and type specific level. Preliminary data on clinical performance look encouraging although further longitudinal studies within screening populations are required to confirm this.
Original languageEnglish
JournalJournal of Clinical Microbiology
Early online date13 Dec 2017
DOIs
Publication statusE-pub ahead of print - 13 Dec 2017

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