| Autor: |
Ditte Møller Ejegod, Jette Junge, Maria Franzmann, Benny Kirschner, Fabio Bottari, Mario Sideri, Maria-Teresa Sandri, Jesper Bonde |
| Jazyk: |
angličtina |
| Rok vydání: |
2016 |
| Předmět: |
|
| Zdroj: |
Papillomavirus Research, Vol 2, Iss , Pp 31-37 (2016) |
| Druh dokumentu: |
article |
| ISSN: |
2405-8521 |
| DOI: |
10.1016/j.pvr.2016.01.003 |
| Popis: |
Background: The novel BD OnclarityTM HPV assay (Onclarity) on the BD Viper™ LT system (BD Diagnostics, Sparks, MD), detects E6/E7 DNA from 13 high-risk HPV genotypes and HPV66. We compared the analytical and clinical performance of the Onclarity Assay to that of Hybrid Capture 2 and LINEAR ARRAY using adjudicated histological outcomes from Danish women referred for colposcopy. Methods: 276 women from Copenhagen, Denmark were referred for colposcopy with abnormal cytology and/or a positive HPV test. Two samples for HPV analysis were taken in BD SurePath™ and in the BD cervical brush diluent (CBD) media. ClinicalTrial gov. identifier: NCT01671462, Ethical Approval: H-4-2012-070. Results: Histology was normal in 84 (31%) women, 70 (26%) had CIN1, 47 (17%) CIN2, and 68 (25%) had CIN3. The Onclarity assay detected 67 out of 68 (99%) ≥CIN3 and 113/115 (98%) ≥CIN2. The specificities for |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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