Clinical Trial: Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Observational

Official Title: Clinical Evaluation of the APTIMA® Assay for Chlamydia Trachomatis Using the PANTHER™ System

Brief Summary: The objective of this multi-center clinical study is to demonstrate that the APTIMA(R) Assay for Chlamydia trachomatis (CT; "ACT Assay"), which is cleared for use on the TIGRIS DTS (Direct Transfer) System ("TIGRIS System"), can be tested on the PANTHER System. The intended use of the ACT Assay will be unchanged except for the inclusion of its use with the PANTHER System. ACT Assay performance on the PANTHER System is comparable to performance on the TIGRIS System.

Detailed Summary: This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis) Assay. Instead, testing was conducted and results were generated with the Gen-Probe APTIMA(R) Combo 2 Assay (for Chlamydia trachomatis and Neisseria gonorrhoeae). See Protocol Identification AC2PS-US11-001 (NCT01733069) for results. This action was recommended by the RRS team per their email to me on 8 February 2013.
Sponsor: Gen-Probe, Incorporated

Current Primary Outcome: Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference [ Time Frame: approximately one year ]

Positive and Negative Percent Agreement Using the TIGRIS Instrument as a Reference


Original Primary Outcome:

Current Secondary Outcome: Positivity Rate [ Time Frame: approximately one year ]

Positivity Rate


Original Secondary Outcome:

Information By: Gen-Probe, Incorporated

Dates:
Date Received: May 20, 2011
Date Started: November 2010
Date Completion:
Last Updated: March 8, 2013
Last Verified: March 2013