TY - JOUR
T1 - Intra-laboratory reproducibility of human papillomavirus identification in cervical specimens by a polymerase chain reaction-based assay
AU - Daniel, Richard W.
AU - Ahdieh, Linda
AU - Hayden, David
AU - Cu-Uvin, Susan
AU - Shah, Keerti V.
N1 - Funding Information:
This study was supported in part from cooperative agreements U64\CCU106795, U64\CCU206798, U64\CCU306802 and U64\CCU506831 from the Centers for Disease Control and Prevention.
PY - 2000
Y1 - 2000
N2 - 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 β-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. Copyright (C) 2000 Elsevier Science B.V.
AB - 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 β-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. Copyright (C) 2000 Elsevier Science B.V.
KW - Assay reproducibility
KW - Human papillomavirus
KW - Polymerase chain reaction
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U2 - 10.1016/S1386-6532(00)00142-6
DO - 10.1016/S1386-6532(00)00142-6
M3 - Article
C2 - 11090755
AN - SCOPUS:0033767620
VL - 19
SP - 187
EP - 193
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
SN - 1386-6532
IS - 3
ER -