RNA extended interventional nucleic acid longitudinal study: Clinical performance of Aptima messenger RNA HPV testing in cervical cancer screening with a 9‐year follow‐up

Abstract

AbstractBackgroundThere is a need for additional longitudinal studies with the Aptima messenger RNA human papillomavirus test (AHPV) to support the safety of extended screening intervals. RNA‐based extended interventional nucleic acid (REINA) provides relevant information on the clinical performance of AHPV.MethodsThis is a longitudinal prospective analysis of 1538 participants after AHPV and liquid‐based cytology (LBC) co‐test complemented with REINA interventional protocol with a second co‐test 4 years after negative screening on 2000 women. Diagnostic accuracy and cumulative risks for CIN2+ up to 9 years were calculated for all test combinations.ResultsSensitivity and specificity for CIN2+ were 96.9% and 88.0% for AHPV and 72.3% and 92.0% for LBC. Negative predictive value (NPV) and positive predictive value (PPV) of AHPV were 99.9% and 23.6%. The 5‐ and 9‐year risks of AHPV‐negative women were 0.4% and 1.0% (CIN2+) and 0.3% and 0.7% (CIN3+), a 73% and 64% lower risk than with negative LBC (p ≤ .002). REINA participants with an AHPV‐positive result at second co‐test after a negative AHPV in first round had a significantly lower 5‐year risk of CIN2+ (11.1%) than AHPV‐positive women with unknown HPV history (29.5%).ConclusionsCurrently, this constitutes the longest European longitudinal study with AHPV testing in screening population. It reveals 99.9% NPV and a significant protective effect of a previous negative test 5 years after a new HPV infection. These findings support the safety of Aptima for screening intervals beyond 5 years. The risk of disease is lower 9 years after a negative AHPV test than 3 years after a negative LBC. High specificity and PPV of Aptima may benefit controlling overtreatment and colposcopy referrals.