Abstract
Background
Despite Aptima assay as the latest US Food Drug Administration (FDA)‐approved high‐risk human papillomavirus (hrHPV) test has been implemented as an adjunct in cervical cancer screening for years, histological follow‐up data remain limited with respect to its performance in women with ASC‐US Pap tests and positive hrHPV results.
Methods
Cases with results of ASC‐US cytology and positive hrHPV by Aptima assay during the period 06/ 2015–02/2017 were retrieved from archived pathology reports. Immediate histological follow‐up results were analyzed within 6 months interval after cotesting.
Results
Among 4196 women with ASC‐US Pap tests and positive hrHPV, 51.1% of them had the immediate histological follow‐up within 6 months. With positive Aptima hrHPV as the adjunct, 46.5% (95%CI 46.2–46.8) of ASC‐US women were found to have cervical intraepithelial neoplasia type 1 (CIN1); 8.8% (95%CI 8.1‐9.5) women were detected CIN2+ lesion including eight adenocarcinoma in‐situ (AIS)s. CIN2+ detection rates were highest in women under 25 (15.4%, n = 65), when comparison with different age cutoffs, younger age women had higher CIN2+ lesion detection rate than that in older group (P <.01).
Conclusion
This is by far one of the largest retrospective studies to analyze the histological follow‐up results of ASC‐US women with positive hrHPV tested by Aptima hrHPV mRNA assay. The results indicated that younger women with ASC‐US and positive hrHPV testing have highest risk of developing high grade CIN lesions as compared to the older women. Lastly, with positive HPV as the adjunct, 55.3% (1186/2145) of ASC‐US women will result in the positive finding on histological follow‐up.
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