ArticleJournal of clinical microbiology2013
The Aptima HPV assay fulfills the cross-sectional clinical and reproducibility criteria of international guidelines for human papillomavirus test requirements for cervical screening.
Article in Journal of clinical microbiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.
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Who cites it
29 citing papers in PubMed, 69 citations in OpenAlex.
- Comparison of mRNA-based and next-generation sequencing HPV assays in a population-based cervical cancer screening program in China.Journal of gynecologic oncology · 2026Article
- Integrating non-coding RNA profiling with HPV genotyping for cervical cancer risk stratification and early detection.Molecular biology reports · 2026Review
- Comparative performance of L1- and E6/E7-targeted HPV genotyping assays based on a unified MeltArray platform.Microbiology spectrum · 2026Article
- Pap testing and high-risk HPV testing for women aged 65 years and older with surgical pathology follow-up.Cancer cytopathology · 2026Article
- Review
- APTIMA mRNA vs. DNA-Based HPV Assays: Analytical Performance Insights from a Resource-Limited South African Setting.International journal of molecular sciences · 2025Article
- Diagnostic accuracy of the Daye diagnostic tampon compared to clinician-collected and self-collected vaginal swabs for detecting HPV: a comparative study.Journal of clinical microbiology · 2025Article
- 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.Cancer cytopathology · 2024Article
- Predictable changes in the accuracy of human papillomavirus tests after vaccination: review with implications for performance monitoring in cervical screening.British journal of cancer · 2024Review
- Do women with high-risk HPV E6/E7 mRNA test positivity and NILM cytology need colposcopy?Infectious agents and cancer · 2023Article
- Widening the offer of human papillomavirus self-sampling to all women eligible for cervical screening: Make haste slowly.International journal of cancer · 2023Review
- HPV Tests Comparison in the Detection and Follow-Up after Surgical Treatment of CIN2+ Lesions.Diagnostics (Basel, Switzerland) · 2022Article
- Extension of cervical screening intervals with primary human papillomavirus testing: observational study of English screening pilot data.BMJ (Clinical research ed.) · 2022Observational
- Advances in HPV Screening Tests for Cervical Cancer-A Review.Journal of obstetrics and gynaecology of India · 2022Review
- Performance of the Human Papillomavirus E6/E7 mRNA Assay in the Primary Screening of Cervical Cancer: Opportunistic Screening in Fujian, China.International journal of women's health · 2022Article
- Performance of human papillomavirus E6/E7 mRNA assay for primary cervical cancer screening and triage: Population-based screening in China.Frontiers in cellular and infection microbiology · 2022Article
- Comparative cost analysis of cervical cancer screening programme based on molecular detection of HPV in Spain.BMC women's health · 2021Article
- p16/ki67 and E6/E7 mRNA Accuracy and Prognostic Value in Triaging HPV DNA-Positive Women.Journal of the National Cancer Institute · 2021Article
- Methodologies of Primary HPV Testing Currently Applied for Cervical Cancer Screening.Life (Basel, Switzerland) · 2020Review
- Article
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The Aptima HPV assay (Hologic Gen-Probe, San Diego, CA) is an FDA-approved assay for detecting human papillomavirus (HPV) E6/E7 mRNA from 14 high-risk HPV types. This study evaluated the clinical performance of the Aptima HPV assay for cervical intraepithelial neoplasia of grade 2 or worse (CIN2+), relative to the high-risk HPV GP5+/GP6+ PCR, in a cross-sectional clinical equivalence analysis using the noninferiority score test with cervical samples from population-based screening, i.e., 69 cervical scraping samples from women with CIN2+ and 843 from women without evidence of CIN2+. In addition, intralaboratory reproducibility over time and interlaboratory agreement of the Aptima HPV assay results were assessed with another set of 548 cervical samples. The Aptima HPV assay showed a clinical sensitivity for CIN2+ of 94.2% (95% confidence interval [CI], 85.5 to 97.8%) and a clinical specificity for CIN2+ of 94.5% (95% CI, 92.8 to 95.9%); by comparison, these figures were 97.1% (95% CI, 89.1 to 99.3%) (67/69 samples) and 93.6% (95% CI, 91.7 to 95.0%) (785/839 samples), respectively, for GP5+/GP6+ PCR. The clinical sensitivity and specificity of the Aptima HPV assay were noninferior to those of GP5+/GP6+ PCR (P = 0.039 and 0.00016, respectively). In addition, high reproducibility of the Aptima HPV assay, as reflected by the intralaboratory reproducibility over time of 96.0% (95% CI, 94.4 to 97.3%) (526/548 samples; kappa = 0.89) and interlaboratory agreement of 96.7% (95% CI, 95.4 to 98.1%) (531/548 samples; kappa = 0.91), was found. Altogether, these data show that the Aptima HPV assay meets the cross-sectional clinical and reproducibility criteria of the international guidelines for HPV test requirements for cervical screening. Longitudinal data are needed to ensure that the long-term negative predictive value of this mRNA assay is similar to those of validated HPV DNA tests.
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