The longitudinal clinical performance of the RNA-based AHPV Human Papillomavirus (HPV) Assay in comparison to the DNA-based Hybrid Capture 2 HPV Test in 2 consecutive screening rounds with a 6-year interval in Germany.
J Clin Microbiol
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Longitudinal data on the E6/E7 mRNA-based AHPV® HPV (AHPV) assay exceeding three years in comparison to the gold standard digene Hybrid Capture® 2 (HC2) test are not available. We previously reported the cross-sectional data of the German AHPV Screening Trial (GAST) where 10,040 women were recruited and tested by liquid-based cytology, the HC2 and the AHPV assay. 411 test-positive women were followed for up to six years. In addition, 3,295 triple-negative women were screened after a median time of six years. Overall 28 CIN3 cases were detected. The absolute risk of developing high risk HPV positive CIN3+ over six years among those women that tested negative at baseline was 2.2 (1.0-4.9) and 3.1 (1.7-5.7) per 1,000 women screened by the HC2 and the AHPV test, the additional risk in AHPV negative compared with HC2 negative was 0.9 (-0.2 to 2.1) per 1,000, whereas the absolute risk following a negative LBC test was 9.3 (2.9-30.2). The relative sensitivity of AHPV compared to HC2 was 91.5% for CIN3+ and the negative predictive values were 99.8 (99.5-99.9) for HC2 and 99.7 (99.4-99.8) for AHPV.Our data show that the longitudinal performance of the AHPV-test over six years is comparable to the performance of the HC2 test and that the absolute risk of CIN3+ over six years following a negative AHPV result in a screening population is low.