Aptima Human Papillomavirus E6/E7 mRNA Test Results Strongly Associated With Risk for High-Grade Cervical Lesions in Follow-Up Biopsies. Issue 3 (July 2018)

• Record Type: Journal Article
• Authors: Ge, Yimin; Christensen, Paul; Luna, Eric; Armylagos, Donna; Xu, Jiaqiong; Schwartz, Mary R.; Mody, Dina R.
• Is Part Of: Journal of lower genital tract disease. Volume 22:Issue 3(2018:Jul.)
• Publication Date: 2018-07
• Subjects: Aptima HPV E6/E7 mRNA test and genotyping -- Cobas HPV test and genotyping -- Papanicolaou (Pap) test -- high-grade cervical lesions (≥HSIL) -- cervical cancer; Generative organs, Female -- Diseases -- Periodicals; Cervix uteri -- Diseases -- Periodicals; Generative organs -- Diseases -- Periodicals; Sexually transmitted diseases -- Periodicals; 618.1
• DOI: 10.1097/LGT.0000000000000393
• Languages: English
• ISSNs: 1089-2591

Abstract

Abstract : Objective: Human papillomavirus (HPV) tests and genotyping (GT) have been used in clinical risk assessment. The purpose of this study was to analyze the performance of 2 common HPV testing platforms in risk evaluation for high-grade cervical lesions. Materials and Methods: Between January 1, 2015, and December 31, 2016, a total of 4, 562 Pap tests with follow-up biopsies in our laboratory database were analyzed along with HPV tests performed on Cobas (CHPV, n = 3, 959) or Aptima (AHPV, n = 603) platforms. Results: The sensitivity for biopsy-confirmed HSIL or worse lesions was 97% for both CHPV and AHPV ( p = .75). AHPV showed significantly lower positive rates than CHPV in benign (56% vs 86%) or LSIL (66% vs 90%) biopsies, resulting in significantly higher specificity for HSIL or worse than CHPV (38% vs 12%, p < .001). AHPV demonstrated significantly higher positive predictive value for HSIL or worse (24% vs 16%, p < .001) and overall accuracy (48% vs 24%, p < .001) than CHPV. AHPV GT also had significantly higher specificity for biopsy-confirmed HSIL or worse than CHPV (88% vs 72%, p < .001) with comparable sensitivity (50% vs 51%, p = .75). Women with HPV 16 on AHPV were significantly more likely to have HSIL or worse on biopsies than those with HPV 16 on CHPV (likelihood ratio = 4.3 vs 2.0, p = .004). Conclusions: Although both AHPV and CHPV were highly sensitive for biopsy-confirmed HSIL or worse lesions, AHPV and GT demonstrated significantly higher specificity and positive predictive value than CHPV. The difference is probably related to E6/E7 overexpression after viral DNA integration in high-grade lesions. The significantly higher specificity and overall accuracy of AHPV and GT for HSIL or worse lesions may be useful in clinical risk management. Abstract : Aptima human papillomavirus E6/E7 mRNA test demonstrated significantly higher specificity and positive predictive value than Cobas human papillomavirus DNA testing for high-grade cervical lesions in follow-up biopsies.