التفاصيل البيبلوغرافية
العنوان: |
Hybrid capture 2 and cobas® 4800: Comparison of performance of two clinically validated tests for human papillomavirus primary screening of cervical cancer |
المؤلفون: |
Mongia, A, Pompeo, G, Sani, C, Burroni, E, Fantacci, G, Bisanzi, S, Cellai, F, Ventura, L, Bottari, F, Carozzi, F |
المصدر: |
Journal of Medical Screening ; volume 28, issue 4, page 472-479 ; ISSN 0969-1413 1475-5793 |
بيانات النشر: |
SAGE Publications |
سنة النشر: |
2021 |
مصطلحات موضوعية: |
Public Health, Environmental and Occupational Health, Health Policy |
الوصف: |
Objective To compare, in a primary human papillomavirus screening setting, two different validated human papillomavirus tests, considering their analytical and clinical screening performances. Methods In Tuscany, a human papillomavirus screening program was implemented in 2013. Hybrid capture 2 (Qiagen) was used for testing until May 2016, when it was replaced by the cobas ® 4800 human papillomavirus test (Cobas; Roche). We evaluated the performance of Hybrid capture 2 and Cobas on: the same screening population in two different periods (before and after changing to Cobas); the same Hybrid capture 2-positive consecutive samples. Discordant samples (Hybrid capture 2-positive/Cobas negative) were typed on the L1 gene (reverse line blot, AB Analitica) and E6/E7 genes (BD Onclarity assay). Results In the considered time period ( n = 37,775), human papillomavirus positivity was 9.8% and 7.4%, respectively, for Hybrid capture 2 and Cobas ( p < 0.0001). At immediate colposcopy, the cervical intraepithelial neoplasia, grade 2 positive predictive value was, respectively, 23.8% and 34% ( p < 0.001). At one-year recall, human papillomavirus persistence was, respectively, 40.6% and 62.2% ( p < 0.0001). Of Hybrid capture 2-positive re-tested samples ( n = 620), 32.4% were Cobas negative. Of discordant samples typed on L1, 7% were positive for the 12 high-risk human papillomavirus. Of the samples found to be negative for the 12 high-risk human papillomavirus types on L1, 14.5% were positive on E6/E7 typing. Among the discordant samples, the only two cervical intraepithelial neoplasia (CIN) grade 3 lesions were non-high-risk human papillomavirus positive on both L1 and E6/E7 typing. Conclusion At baseline, Hybrid capture 2 showed greater human papillomavirus positivity and a lower CIN2+ positive predictive value than Cobas, which was more specific than Hybrid capture 2 in detection of high-risk human papillomavirus: 80% of discordant samples were confirmed as high-risk human papillomavirus negative. This higher ... |
نوع الوثيقة: |
article in journal/newspaper |
اللغة: |
English |
DOI: |
10.1177/0969141321992820 |
الإتاحة: |
https://doi.org/10.1177/0969141321992820Test |
حقوق: |
http://journals.sagepub.com/page/policies/text-and-data-mining-licenseTest |
رقم الانضمام: |
edsbas.60E77AB4 |
قاعدة البيانات: |
BASE |