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J Clin Microbiol. 2010 Mar;48(3):797-801. doi: 10.1128/JCM.01743-09. Epub 2009 Dec 30.

Comparison of the clinical performance of PapilloCheck human papillomavirus detection with that of the GP5+/6+-PCR-enzyme immunoassay in population-based cervical screening.

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Department of Pathology, VU University Medical Center, de Boelelaan 1117, Amsterdam 1081 HV, Netherlands.


We compared the clinical performance of the PapilloCheck human papillomavirus (HPV) assay with that of the GP5+/6+-PCR method with an enzyme immunoassay readout (GP5+/6+-PCR-EIA) for the detection of high-risk HPV (hrHPV) types by the use of cervical samples originating from women in a population-based by the use of cervical screening cohort tested by combined cytology and GP5+/6+-PCR-EIA (POBASCAM trial). Specimens from a random sample of 1,437 controls (women ages 40 to 60 years with normal cytological findings and without evidence of cervical intraepithelial neoplasia grade 2 or higher [> or = CIN2] within up to 8 years of follow-up) and 192 cases (women ages 30 to 60 years in whom > or = CIN3 was detected within up to 3 years of follow-up) were subjected to analysis by the PapilloCheck method. When all 17 (probably) hrHPV types were taken into account, the PapilloCheck assay had a clinical sensitivity for the detection of > or = CIN3 of 96.4% (185/192 samples; 95% confidence interval [CI], 93.7 to 99.7) and a clinical specificity for the detection of > or = CIN2 of 96.3% (95% CI, 95.3 to 97.3). After restriction of the analysis by the PapilloCheck assay to the 14 hr HPV types targeted by GP5+/6+-PCR-EIA, the clinical sensitivity and clinical specificity values were 95.8% (95% CI, 92.8 to 98.8) and 96.7% (95% CI, 95.7 to 97.7), respectively. By comparison, these values were 96.4% (95% CI, 93.9 to 98.9) and 97.7% (95% CI, 96.9 to 98.5), respectively, for the GP5+/6+-PCR-EIA. When all 17 (probably) hrHPV types were included in the analysis, noninferiority score testing revealed that the clinical sensitivity of the PapilloCheck assay for the detection of > or = CIN3 was noninferior to that of the GP5+/6+-PCR-EIA (P < 0.0001), but the clinical specificity of the PapilloCheck assay for the detection of > or = CIN2 was inferior to that of the GP5+/6+-PCR-EIA (P = 0.08) when lower bounds of 90% for sensitivity and 98% for specificity were used. When the analysis was restricted to the 14 hrHPV types targeted by the GP5+/6+-PCR-EIA, both the clinical sensitivity and the clinical specificity of the PapilloCheck assay were noninferior to those of the GP5+/6+-PCR-EIA (noninferiority score test; P < 0.0001 and P = 0.007, respectively). Thus, when the findings obtained for the 14 hrHPV types detectable by the GP5+/6+-PCR-EIA are considered, the PapilloCheck assay is clinically compatible with the GP5+/6+-PCR-EIA.

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