Anyplex II HPV28 detection and Anyplex II HPV HR detection assays are highly concordant with other commercial assays for detection of high-risk HPV genotypes in women with high grade cervical abnormalities

作者：Cornall A M^*; Poljak M; Garland S M; Phillips S; Tan J H; Machalek D A; Quinn M A; Tabrizi S N

来源：European Journal of Clinical Microbiology & Infectious Diseases, 2017, 36(3): 545-551.

DOI：10.1007/s10096-016-2831-5

Purpose: to evaluate the performance of Anyplex II HPV28 and HPV HR Detection assays against the EuroArray HPV, Cobas 4800 HPV (Cobas), HPV Amplicor (Amp), Linear Array HPV (LA) and Hybrid Capture 2 (HC2) in detection of high-risk HPV (HR-HPV) from liquid-based cervical cytology samples. Methods: cervical specimens from 404 women undergoing management of high-grade cytological abnormality were evaluated by Anyplex II HPV28 and HPV HR Detection assays for detection of HR-HPV genotypes and prediction of histologically-confirmed cervical intraepithelial neoplasia grade 2 or higher (CIN2). The results were compared to EuroArray, HC2, Cobas, Amp, and LA. Results: specimens were evaluated from 404 women with an average age of 30 years, including 336 with a histological diagnosis of CIN2 and 68 with CIN1. Concordance of HR-HPV detection between Anyplex II HPV28 and other genotyping assays was 94.79 % (kappa = 0.84; EuroArray) and 97.27 % (kappa = 0.91; LA); and between Anyplex II HPV HR and other HR-HPV detection assays was 86.35 % (kappa = 0.62; HC2), 96.03 % (kappa = 0.87; Cobas) and 96.77 % (kappa = 0.89; Amp). Using HR-HPV detection for prediction of CIN2 by Anyplex II HPV28 and HPV HR, sensitivity (90.18, 95 % CI 86.48-93.14; 90.77, 95 % CI 87.16-93.65) and specificity (both 67.16, 95 % CI 54.60-78.15) were not significantly different to the other HPV assays tested, with one exception. Both Anyplex assays had significantly higher sensitivity than HC2 (p < 0.0001), with a specificity of 96 % (p > 0.05) of HC2 in this high-risk population. Conclusions: both Anyplex II HPV detection assays were concordant with other commercial assays for HR-HPV detection, with comparable sensitivity and specificity for CIN2 detection.

• 出版日期2017-3