NCT01358799

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Gen-Probe, Incorporated · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

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 description

This protocol was withdrawn from clinical trials.gov because samples collected under this protocol were not tested per protocol using the Gen-Probe APTIMA(R) CT (Chlamydia trachomatis)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.

Conditions

• Chlamydia Trachomatis

Interventions

Type	Name	Description
DEVICE	APTIMA Assay for Chlamydia trachomatis	APTIMA Assay for Chlamydia trachomatis

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-05-24
• Last updated: 2013-03-12

Locations

7 sites across 1 country: United States