Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System
| Status: | Archived |
|---|---|
| Conditions: | Infectious Disease, Women's Studies, Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery, Immunology / Infectious Diseases, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | November 2011 |
| End Date: | December 2011 |
| Contact: | Philip Estes |
| Email: | philip.estes@gen-probe.com |
| Phone: | 858-731-5842 |
The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is
comparable to performance on the TIGRIS System.
The APTIMA HPV Assay is an in vitro nucleic acid amplification test for the qualitative
detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human
papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay
include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The APTIMA HPV Assay
does not discriminate between the 14 high-risk types. Cervical specimens collected in
ThinPrep Pap Test vials containing PreservCyt® Solution with commercially available
collection devices (broom-type device or cytobrush/spatula combination) may be tested with
the APTIMA HPV Assay either pre- or post-Pap processing. The assay is used with the TIGRIS
System and the PANTHER System.
The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is
comparable to performance on the TIGRIS System.
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials