Abstract
Background: The recently FDA (U.S. food and drug administration) approved Roche Cobas® 4800 (Cobas) human papillomavirus (HPV) has limited performance data compared to current HPV detection methods for test of cure in women undergoing treatment for high grade lesions. Objective: Evaluation of Cobas HPV assay using historical samples from women undergoing treatment for cervical dysplasia. Study design: A selection of 407 samples was tested on the Cobas assay and compared to previous results from Hybrid Capture 2, HPV Amplicor and Roche Linear Array. Results: Overall, a correlation between high-risk HPV positivity and high grade histological diagnosis was 90.6% by the Cobas, 86.1% by Hybrid Capture 2, 92.9% by HPV Amplicor and 91.8% by Roche Linear Array. Conclusion: The Cobas HPV assay is comparative to both the HPV Amplicor and Roche Linear Array assays and better than Hybrid capture 2 assay in the detection of High-Risk HPV in women undergoing treatment for cervical dysplasia.
Original language | English |
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Pages (from-to) | 63-65 |
Number of pages | 3 |
Journal | Journal of Clinical Virology |
Volume | 62 |
DOIs | |
Publication status | Published - Jan 2015 |
Externally published | Yes |
Keywords
- Amplicor
- Diagnostic
- Human papillomavirus
- Hybrid capture
- Linear array
- Roche cobas