Comparison of HPV DNA Detection Methods: cobas ® 4800 HPV Test, PapilloCheck® HPV-Screening, and LMNX Genotyping Kit HPV GP

Introduction

Cervical cancer is the seventh most common malignancy caused by aggressive subtypes of human papillomavirus (HPV). In the Czech Republic, the cytologybased cervical cancer screening is available since 2008. It has been already proven that HPV-based cervical cancer screening is more effective and efficient for prevention of invasive cervical cancer and its mortality than cytology-based screening. The aim of this study was to compare the sensitivity and specificity of three PCR-based HPV DNA detection assays: cobas® 4800 HPV Test (Roche), PapilloCheck® HPV-Screening (Greiner Bio-One), and LMNX Genotyping Kit HPV GP (Diassay).

Materials/methods 

1374 women from the Czech Republic, age 17-73 (33.51±7.89), were sampled for cervical smear by physician (1198) or for cervicovaginal smear by selfsampling (176). DNA was isolated by cobas x 480 automatic extraction. All samples were tested by cobas® 4800 HPV Test and PapilloCheck® HPV-Screening test. 372 samples have been also tested by LMNX Genotyping Kit HPV GP. Sensitivity, specificity, and Cohen‘s kappa coefficients (?) of these methods were calculated using consensual HPV status (defined by agreement of at least two methods) as a gold standard. Based on expression of interest, 215 self-sampling kits were posted to women. Evalyn® Brush (Rovers Medical) cervicovaginal swabs obtained by self-sampling were analyzed for the presence of HPV infection by Cobas 4800 HPV (Roche) followed by genotyping using PapilloCheck® HPVScreening (Greiner Bio-One). Sixty women randomly chosen from our sample were sent a questionnaire focused on their experience with self-sampling.

Results and conclusions

The cobas® 4800 HPV Test was the most sensitive and the most specific method for hrHPV detection. Sensitivity (SE) and specificity (SP) of LMNX Genotyping Kit HPV GP (SE=0.947; SP=0.957; ?=0.883) was almost as high as cobas® 4800 HPV (SE=0.983, SP=0.992, ?=0.970). Despite the lower sensitivity of PapilloCheck® HPV-Screening, its specificity was very high (SE= 0.897, SP=0.989, ?=0.906). Our results could be affected by DNA isolation technique which is optimal for cobas® 4800 HPV Test but is not recommended for PapilloCheck® HPV-Screening and LMNX Genotyping Kit HPV GP tests. All tested methods have been found highly specific for detection of hrHPV infection; the sensitivity of PapilloCheck® HPV-Screening was comparatively lower then of other two methods.

Study funding: IGA_LF_2015_010, CZ.1.05/3.1.00/14.0307. Authors claim no conflict of interests