Clinical Evaluation of the APTIMA® HPV Assay Using the PANTHER™ System

Completed

Conditions studied: Human Papilloma Virus Infection

In brief

The objective is to establish that APTIMA HPV Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Key facts

Study ID

NCT01446198

Run by

Gen-Probe, Incorporated

People needed

11816

Starts

2012-03-01

Expected to finish

2012-05-01

Last updated by the study team

2012-07-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• sample integrity was compromised (eg, stored under unacceptable conditions)

Where it is running

• Gen-Probe Incorporated — San Diego, California, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• LabCorp Corporation of America — Burlington, North Carolina, United States

Full record on ClinicalTrials.gov

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