To date there are no data available on the 5-year longitudinal clinical performance of the RNA-based Aptima HPV test (AHPV) in screening populations. Thus, we compared AHPV and HC2 performances to liquid-based cytology (LBC) in women aged 30–65 attending routine cervical screening and follow both test-positive and -negative women for up to 5 years.
Women (N=10,040) were screened at office-based gynaecologists. All specimens were collected and tested centrally by LBC, AHPV and HC2. Women were referred to colposcopy if they had an abnormal cytology result and/or were tested positive on either HPV assay. Sensitivity, specificity and positive predictive values were calculated based on review histology. For follow-up, 482 women with a positive test result and no treatment were followed up for 5 years with annual testing. In addition, 5 years after baseline, cervical samples are being collected from a random sample of 4000 study participants who tested triple negative at baseline for determination of the longitudinal negative predictive value (NPV) and HPV related disease after a 5 year period.
Cross-sectional results of 9336 women have recently been published and show comparable sensitivities for CIN2+ and CIN3+ detection, while the positive predictive value (PPV) and specificity for <CIN2+ was significantly higher for the AHPV test compared to HC2. An interim analysis of the 48 months follow-up data shows a cumulative proportion of HPV clearance at month 28 of 78%. With regard to 15 incident CIN3+ lesions during follow up we calculated a PPV of the HC2 and AHPV base line test result of 3.9% (2.0-6.8) vs 5.0% (2.6-8.6), respectively, while the number of women requiring follow up deduced from the base line result is lower for women tested by the AHPV test. Furthermore, preliminary data from 10% of the target population of the 5-year follow-up cohort of triple-negative women suggest a similar longitudinal NPV of AHPV and HC2. More robust data will be presented at the conference.
In conclusion, our data demonstrate a non-inferior performance of the RNA-based AHPV test in comparison to the gold-standard DNA-based HC2 test.