ArticleAmerican journal of translational research2026
Comparative performance of standalone E6/E7 mRNA testing versus a combined DNA genotyping and viral load assay for detecting cervical high-grade lesions: a retrospective paired study.
Article in American journal of translational research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectiveTo compare the diagnostic performance of standalone E6/E7 mRNA testing versus a combined HPV DNA genotyping and viral load assay for detecting cervical high-grade lesions (CIN2+) and to validate performance, biological rationale, and clinical utility.
methodsThis single-center, retrospective, paired diagnostic accuracy study included 150 women in the primary cohort and 100 in an independent validation cohort, all referred for colposcopy. Participants underwent both the E6/E7 mRNA test (Aptima) and the combined DNA test (genotyping + Hybrid Capture 2 viral load) within one month prior to biopsy. Histopathology was the reference standard. Analyses included diagnostic performance metrics, correlation of viral load with histopathology, subgroup assessments, and follow-up of 65 DNA+/mRNA- women.
resultsIn the primary cohort, the sensitivity of the mRNA assay (87.7%) was not significantly different from that of the DNA test (94.7%, P=0.221), but the specificity was significantly higher (P<0.001). The mRNA signal strongly correlated with histopathological severity (ρ=0.72, P<0.001) and was stronger than the DNA load (ρ=0.38, P<0.001). Validation confirmed these results. Subgroup analyses showed superior mRNA specificity in women <30 years (96.7% vs. 60.0%) and for ASCUS triage (92.7% vs. 63.4%). The mRNA assay effectively refined risk among DNA-positive patients.
conclusionThe E6/E7 mRNA assay provides significantly higher specificity and positive predictive value for CIN2+ detection than a comprehensive DNA-based strategy, without significant sensitivity loss. Its reproducible performance, biological rationale, and proven safety support its role in enhancing precision screening, particularly for ASCUS, young women, and HPV DNA-positive individuals.
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