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?

Autor: Fokom Domgue J; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA fokom.domgue@gmail.com.; Department of Gynecology and Obstetrics, University Hospital Centre of Yaounde, Yaounde, Cameroon., Schiffman M; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA., Wentzensen NH; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA., Gage JC; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA., Castle PE; Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York, USA., Raine-Bennett TR; Women's Health Research Institute, Division of Research, Kaiser Permanente Northern California, Oakland, California, USA., Fetterman B; Regional Laboratory, Kaiser Permanente Northern California, Berkeley, California, USA., Lorey T; Regional Laboratory, Kaiser Permanente Northern California, Berkeley, California, USA., Poitras NE; Regional Laboratory, Kaiser Permanente Northern California, Berkeley, California, USA., Befano B; Information Management Services, Silver Spring, Maryland, USA., Xie Y; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA., Miachon LS; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA.; Department of Epidemiology and Biostatistics, The George Washington University Milken Institute School of Public Health, Washington, DC, USA., Dean M; Division of Cancer Epidemiology and Genetics, National Cancer Institute, Bethesda, Maryland, USA.
Jazyk: angličtina
Zdroj: Journal of clinical microbiology [J Clin Microbiol] 2017 Aug; Vol. 55 (8), pp. 2348-2355. Date of Electronic Publication: 2017 May 17.
DOI: 10.1128/JCM.00492-17
Abstrakt: 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 [ (Copyright © 2017 American Society for Microbiology.)
Databáze: MEDLINE