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. 2014 May;60(1):44-9.
doi: 10.1016/j.jcv.2014.02.002. Epub 2014 Feb 14.

Individual detection of 14 high risk human papilloma virus genotypes by the PapType test for the prediction of high grade cervical lesions

Affiliations

Individual detection of 14 high risk human papilloma virus genotypes by the PapType test for the prediction of high grade cervical lesions

Jack Cuzick et al. J Clin Virol. 2014 May.

Abstract

Background: HR HPV genotypes when assayed collectively, achieve high sensitivity but low specificity for the prediction of CIN2+. Knowledge of the specific genotypes in an infection may facilitate the use of HR HPV detection in routine clinical practice.

Objectives: To compare the rate of HR HPV detection and the accuracy of CIN2+ prediction between PapType test (Genera Biosystems) and other commercially available HR HPV assays, and to examine the value of full HPV genotyping.

Study design: PreservCyt samples from 1099 women referred for abnormal cervical cytology were used. CIN2+ was chosen as the primary end-point but CIN3+ was also evaluated. A hierarchy of HR HPV genotypes was created using PPV and this was used to create 3 groups of genotypes with potentially different management.

Results: The PapType assay has a specificity of 22.4% and a sensitivity of 94.6% for CIN2+ prediction. Classification into Groups A (HPV33 and HPV16, very highly predictive), B (HPV31, 18, 52, 35, 58, 51 highly predictive) and C (HPV68, 45, 39, 66, 56, 59, intermediate predictive) could double the specificity (44.5%) but only slightly reduce the sensitivity for CIN2+ (91.5%) and CIN3+ (94.0%).

Conclusions: The PapType assay is a simple, reproducible and effective test for HR HPV detection and genotyping. HPV 33 was found to have a very high PPV and should therefore be managed as for HPV16.

Keywords: CIN; Cervix; Genotypes; High risk HPV; Positive predictive value.

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Figures

Fig. 1
Fig. 1
Detection of CIN2+ by different HR HPV assays. Sensitivity and specificity are indicated with 95%CIs. APTIMA (Hologic/Gen-Probe), BD Viper LT (Becton Dickinson), CINtecp16 (Roche mtm), Cobas (Roche), HC2 (Qiagen), PapType (Genera), PreTectHPV-Proofer (Norchip), RealTime (Abbott).
Fig. 2
Fig. 2
ROC curve of cumulative sensitivity and specificity for CIN2+ (•—•) or CIN3+ (ο - - ο) when genotypes are ordered according to positive predictive value in women not already deemed positive by prior genotypes.
Fig. 3
Fig. 3
Odds ratio for CIN2+ for multiple versus single type infection. For all individual genotypes except HPV16, the multiple infections considered are those which do not include HPV16. There were no CIN2+ lesions with single HPV59 infection.

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