Clinical Validation of a Type-Specific Real-Time Quantitative Human Papillomavirus PCR against the Performance of Hybrid Capture 2 for the Purpose of Cervical Cancer Screening

被引:44
作者
Depuydt, C. E. [1 ]
Benoy, I. H. [1 ]
Beert, J. F. A. [1 ]
Criel, A. M. [1 ]
Bogers, J. J. [1 ,2 ]
Arbyn, M. [3 ]
机构
[1] Sonic Healthcare Benelux, Dept Mol Diagnost, RIATOL, Antwerp, Belgium
[2] Univ Antwerp, Lab Cell Biol & Histol, B-2020 Antwerp, Belgium
[3] Sci Inst Publ Hlth, Canc Epidemiol Unit, Brussels, Belgium
基金
欧盟第七框架计划;
关键词
VIRAL LOAD; WOMEN; GUIDELINES; RISK;
D O I
10.1128/JCM.01231-12
中图分类号
Q93 [微生物学];
学科分类号
071005 ; 100705 ;
摘要
To be acceptable for use in cervical cancer screening, a new assay that detects DNA of high-risk human papillomavirus (hrHPV) types must demonstrate high reproducibility and performance not inferior to that of a clinically validated HPV test. In the present study, a real-time quantitative PCR (qPCR) assay targeting the E6 and E7 genes of hrHPV was compared with Hybrid Capture 2 (hc2) in a Belgian cervical cancer screening setting. In women >30 years old, the sensitivity and specificity for intraepithelial neoplasias of grade 2 or worse (93 cases of cervical intraepithelial neoplasias of grade 2 or worse (CIN2+) and 1,207 cases of no CIN or CIN1) were 93.6% and 95.6%, respectively, and those of hc2 were 83.9% and 94.5%, respectively {relative sensitivity of qPCR/hc2 = 1.12 [95% confidence interval (CI), 1.01 to 1.23]; relative specificity = 1.01 [95% CI, 0.99 to 1.03]}. A score test showed that the sensitivity (P < 0.0001) and specificity (P < 0.0001) of the qPCR assay were not inferior to those of hc2 at the required thresholds of 90% and 98%, respectively. The overall agreement of hrHPV positivity between the two runs of the qPCR tests was 98.7% (95% CI, 97.5 to 99.4%), with a kappa value of 0.96 (95% CI, 0.83 to 1.00). The qPCR assay used in this study can be considered a reliable HPV assay that fulfills the clinical validation criteria defined for use in cervical cancer screening.
引用
收藏
页码:4073 / 4077
页数:5
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