ArticleJournal of clinical microbiology2011
Comparison of clinical and analytical performance of the Abbott Realtime High Risk HPV test to the performance of hybrid capture 2 in population-based cervical cancer screening.
Article in Journal of clinical microbiology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
27 citing papers in PubMed, 74 citations in OpenAlex.
- Mapping the HPV Detection Landscape in Botswana: A Narrative Review of Diagnostic Platforms and Their Impact on Cervical Cancer Control.Health science reports · 2026Article
- Clinically validated HPV assays offer comparable long-term safety in primary cervical cancer screening: A 9-year follow-up of a population-based screening cohort.International journal of cancer · 2025Article
- Clinical Validation of the Fully Automated NeuMoDx HPV Assay for Cervical Cancer Screening.Viruses · 2022Article
- Classification of high-grade cervical intraepithelial neoplasia by p16International journal of cancer · 2021Article
- Clinical and Analytical Evaluation of the Alinity m HR HPV Assay within the VALGENT-3 Framework.Journal of clinical microbiology · 2021Article
- Methylation markers FAM19A4 and miR124-2 as triage strategy for primary human papillomavirus screen positive women: A large European multicenter study.International journal of cancer · 2021Article
- Evaluation and Optimization of the Clinical Accuracy of Hybribio's 14 High-Risk HPV with 16/18 Genotyping Assay within the VALGENT-3 Framework.Journal of clinical microbiology · 2020Article
- Histomorphologic assessment and distribution of high-risk human papillomavirus (HPV) types in cervical high-grade squamous intraepithelial lesions with unusual histomorphologic features.Virchows Archiv : an international journal of pathology · 2020Article
- Alinity m HR HPV Assay Fulfills Criteria for Human Papillomavirus Test Requirements in Cervical Cancer Screening Settings.Journal of clinical microbiology · 2019Article
- Amplification chemistries in clinical virology.Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2019Review
- Article
- DNA methylation markers as a triage test for identification of cervical lesions in a high risk human papillomavirus positive screening cohort.International journal of cancer · 2019Article
- Clinical and Analytical Evaluation of the Anyplex II HPV HR Detection Assay within the VALGENT-3 Framework.Journal of clinical microbiology · 2018Article
- Clinical Evaluation of INNO-LiPA HPV GenotypingInternational journal of molecular sciences · 2018Article
- Evaluation of the Clinical Performance of the HPV-Risk Assay Using the VALGENT-3 Panel.Journal of clinical microbiology · 2017Article
- The Value of Partial HPV Genotyping After Conization of Cervical Dysplasias.Geburtshilfe und Frauenheilkunde · 2017Article
- Study-based evaluation of the Abbott RealTime High Risk HPV test in comparison to the HC2 HR HPV test in women aged ≥30 years using residual LBC ThinPrep specimens.BMC infectious diseases · 2016Article
- Significance of "Not Detected but Amplified" Results by Real-Time PCR Method for HPV DNA Detection.BioMed research international · 2016Article
- HPV-Testing in Follow-up of Patients Treated for CIN2+ Lesions.Journal of Cancer · 2016Review
- Human papillomavirus infection and cervical dysplasia in female sex workers in Northeast China: an observational study.BMC public health · 2015Observational
Corrections and comments
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Authors and funding
8 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The clinical performance of the Abbott RealTime High Risk HPV (human papillomavirus) test (RealTime) and that of the Hybrid Capture 2 HPV DNA test (hc2) were prospectively compared in the population-based cervical cancer screening setting. In women >30 years old (n = 3,129), the clinical sensitivity of RealTime for detection of cervical intraepithelial neoplasia of grade 2 (CIN2) or worse (38 cases) and its clinical specificity for lesions of less than CIN2 (3,091 controls) were 100% and 93.3%, respectively, and those of hc2 were 97.4% and 91.8%, respectively. A noninferiority score test showed that the clinical specificity (P < 0.0001) and clinical sensitivity (P = 0.011) of RealTime were noninferior to those of hc2 at the recommended thresholds of 98% and 90%. In the total study population (women 20 to 64 years old; n = 4,432; 57 cases, 4,375 controls), the clinical sensitivity and specificity of RealTime were 98.2% and 89.5%, and those of hc2 were 94.7% and 87.7%, respectively. The analytical sensitivity and analytical specificity of RealTime in detecting targeted HPV types evaluated with the largest sample collection to date (4,479 samples) were 94.8% and 99.8%, and those of hc2 were 93.4% and 97.8%, respectively. Excellent analytical agreement between the two assays was obtained (kappa value, 0.84), while the analytical accuracy of RealTime was significantly higher than that of hc2. RealTime demonstrated high intralaboratory reproducibility and interlaboratory agreement with 500 samples retested 61 to 226 days after initial testing in two different laboratories. RealTime can be considered to be a reliable and robust HPV assay clinically comparable to hc2 for the detection of CIN2+ lesions in a population-based cervical cancer screening setting.
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