Assessment of a New Lower-Cost Real-Time PCR Assay for Detection of High-Risk Human Papillomavirus: Useful for Cervical Screening in Limited-Resource Settings?

Journal of Clinical Microbiology
Joel Fokom DomgueMichael Dean

Abstract

Inexpensive and easy-to-perform human papillomavirus (HPV) tests are needed for primary cervical cancer screening in lower-resource regions. In a convenience sample of 516 residual exfoliative cervical specimens from the Kaiser Permanente Northern California and U.S. National Cancer Institute Persistence and Progression Study, we assessed the agreement and clinical performance of a simple, inexpensive real-time PCR assay for the detection of 13 carcinogenic HPV types (the H13 assay; Hybribio, Hong Kong) that is marketed in limited-resource settings compared to previous testing by the Hybrid Capture 2 assay (HC2; Qiagen, Germantown, MD) and the Onclarity assay (BD Diagnostics, Sparks, MD). The test set was chosen to include many HPV-positive specimens. The reference standard was a combination of HC2 and Onclarity results for HPV detection and histologic diagnosis of controls (less than cervical intraepithelial neoplasia grade 2 [<CIN2]) or cases (cervical intraepithelial neoplasia grade 2 or higher [CIN2+]) for disease status. In this enriched convenience sample, H13 tested positive for 94.4% of the 108 HC2- and Onclarity-positive CIN2+ specimens and negative for 88.2% of the 51 HC2- and Onclarity-negative <CIN2 specimens. H13 p...Continue Reading

References

Apr 3, 2009·The New England Journal of Medicine·Rengaswamy SankaranarayananKetayun A Dinshaw
Jul 8, 2015·Gynecologic Oncology·Mark SchiffmanNicolas Wentzensen
Aug 11, 2016·International Journal of Cancer. Journal International Du Cancer·Mark SchiffmanNicolas Wentzensen
Dec 3, 2016·Nature Reviews. Disease Primers·Mark SchiffmanSilvia Franceschi

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