TY - JOUR T1 - Performance of a Cartridge-Based Assay for Detection of Clinically Significant Human Papillomavirus (HPV) Infection: Lessons from VALGENT (Validation of HPV Genotyping Tests). JF - J Clin Microbiol Y1 - 2016 A1 - Cuschieri, Kate A1 - Geraets, Daan A1 - Cuzick, Jack A1 - Cadman, Louise A1 - Moore, Catherine A1 - Vanden Broeck, Davy A1 - Padalko, Elisaveta A1 - Quint, Wim A1 - M. Arbyn KW - ADOLESCENT KW - Adult KW - Aged KW - Early Detection of Cancer KW - Female KW - Genotyping Techniques KW - Humans KW - middle aged KW - Papillomaviridae KW - Papillomavirus Infections KW - Reproducibility of Results KW - Sensitivity and Specificity KW - United Kingdom KW - Uterine Cervical Neoplasms KW - Young adult AB -

The Validation of Human Papillomavirus (HPV) Genotyping Tests (VALGENT) studies offer an opportunity to clinically validate HPV assays for use in primary screening for cervical cancer and also provide a framework for the comparison of analytical and type-specific performance. Through VALGENT, we assessed the performance of the cartridge-based Xpert HPV assay (Xpert HPV), which detects 14 high-risk (HR) types and resolves HPV16 and HPV18/45. Samples from women attending the United Kingdom cervical screening program enriched with cytologically abnormal samples were collated. All had been previously tested by a clinically validated standard comparator test (SCT), the GP5+/6+ enzyme immunoassay (EIA). The clinical sensitivity and specificity of the Xpert HPV for the detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) and CIN3+ relative to those of the SCT were assessed as were the inter- and intralaboratory reproducibilities according to international criteria for test validation. Type concordance for HPV16 and HPV18/45 between the Xpert HPV and the SCT was also analyzed. The Xpert HPV detected 94% of CIN2+ and 98% of CIN3+ lesions among all screened women and 90% of CIN2+ and 96% of CIN3+ lesions in women 30 years and older. The specificity for CIN1 or less (≤CIN1) was 83% (95% confidence interval [CI], 80 to 85%) in all women and 88% (95% CI, 86 to 91%) in women 30 years and older. Inter- and intralaboratory agreements for the Xpert HPV were 98% and 97%, respectively. The kappa agreements for HPV16 and HPV18/45 between the clinically validated reference test (GP5+/6+ LMNX) and the Xpert HPV were 0.92 and 0.91, respectively. The clinical performance and reproducibility of the Xpert HPV are comparable to those of well-established HPV assays and fulfill the criteria for use in primary cervical cancer screening.

VL - 54 CP - 9 U1 - http://www.ncbi.nlm.nih.gov/pubmed/27385707?dopt=Abstract M3 - 10.1128/JCM.00897-16 ER -