R W Daniel1, L Ahdieh, D Hayden, S Cu-Uvin, K V Shah. 1. The W. Harry Feinstone Department of Molecular Microbiology and Immunology, School of Public Health, Johns Hopkins University, 615 N. Wolfe Street, Baltimore, MD 21205, USA.
Abstract
BACKGROUND: polymerase chain reaction (PCR)-based assays for human papillomavirus (HPV) sequences are in wide use in clinical and epidemiological studies. The reproducibility of these assays is not extensively studied. OBJECTIVES: to estimate the intra-laboratory reproducibility of generic and type-specific HPV diagnoses by the MY09/MY11/HMB01 consensus L1 primer-based PCR assay. STUDY DESIGN: systematically collected specimens (n=207) were masked and retested. RESULTS: when specimens negative in both initial and repeat assays were excluded from analysis, the diagnostic reproducibility was 98. 6% for beta-globin, 90.7% for generic HPV (any HPV type), and 76.9% for type-specific HPVs. The reproducibility of type-specific diagnosis increased with increase in signal strength in the hybridization reaction of the initial assay. When a specimen contained five or more HPV types in the initial assay, it was rare to identify all of the HPV types in the repeat assay. CONCLUSIONS: the degree of reproducibility of the PCR diagnosis should be taken into account in the interpretation of HPV data in clinical and epidemiological studies.
BACKGROUND: polymerase chain reaction (PCR)-based assays for human papillomavirus (HPV) sequences are in wide use in clinical and epidemiological studies. The reproducibility of these assays is not extensively studied. OBJECTIVES: to estimate the intra-laboratory reproducibility of generic and type-specific HPV diagnoses by the MY09/MY11/HMB01 consensus L1 primer-based PCR assay. STUDY DESIGN: systematically collected specimens (n=207) were masked and retested. RESULTS: when specimens negative in both initial and repeat assays were excluded from analysis, the diagnostic reproducibility was 98. 6% for beta-globin, 90.7% for generic HPV (any HPV type), and 76.9% for type-specific HPVs. The reproducibility of type-specific diagnosis increased with increase in signal strength in the hybridization reaction of the initial assay. When a specimen contained five or more HPV types in the initial assay, it was rare to identify all of the HPV types in the repeat assay. CONCLUSIONS: the degree of reproducibility of the PCR diagnosis should be taken into account in the interpretation of HPV data in clinical and epidemiological studies.
Authors: Daniel C Beachler; Krystle A Lang Kuhs; Linda Struijk; John Schussler; Rolando Herrero; Carolina Porras; Allan Hildesheim; Bernal Cortes; Joshua Sampson; Wim Quint; Paula Gonzalez; Aimée R Kreimer Journal: Sex Transm Dis Date: 2017-07 Impact factor: 2.830
Authors: Janet R Kornegay; Michel Roger; Philip O Davies; Amanda P Shepard; Nayana A Guerrero; Belen Lloveras; Darren Evans; François Coutlée Journal: J Clin Microbiol Date: 2003-03 Impact factor: 5.948
Authors: K V Shah; R W Daniel; M K Tennant; N Shah; K T McKee; C A Gaydos; J C Gaydos; A Rompalo Journal: Sex Transm Infect Date: 2001-08 Impact factor: 3.519
Authors: Jill Koshiol; Lisa Lindsay; Jeanne M Pimenta; Charles Poole; David Jenkins; Jennifer S Smith Journal: Am J Epidemiol Date: 2008-05-15 Impact factor: 4.897