NCT01733069

Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System

Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,912 (actual)
• Sponsor: Gen-Probe, Incorporated · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Accepted

Summary

The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.

Detailed description

The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from protocol ACTPS-US10-001(NCT01358799). The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).

Conditions

• Chlamydia Trachomatis
• Neisseria Gonorrhoeae Infection

Interventions

Type	Name	Description
DEVICE	APTIMA COMBO 2 Assay (AC2 Assay)	APTIMA COMBO 2 Assay (AC2 Assay

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2012-11-26
• Last updated: 2014-01-14
• Results posted: 2013-04-24

Locations

7 sites across 1 country: United States