Status:
COMPLETED
Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System
Lead Sponsor:
Gen-Probe, Incorporated
Conditions:
Human Papilloma Virus Infection
Eligibility:
FEMALE
18+ years
Brief Summary
The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- the sample had an aliquot with a valid positive or negative APTIMA HPV Assay TIGRIS System result (from testing under protocol 2007HPVASCUS30)
- an aliquot is available and suitable for testing, and
- the sample was randomly selected for inclusion.
Exclusion
- sample integrity was compromised (eg, stored under unacceptable conditions)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
11816 Patients enrolled
Trial Details
Trial ID
NCT01446198
Start Date
March 1 2012
End Date
May 1 2012
Last Update
July 3 2012
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Gen-Probe Incorporated
San Diego, California, United States, 92121
2
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
3
LabCorp Corporation of America
Burlington, North Carolina, United States, 27215