CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,912 enrolled
Drug / intervention
APTIMA COMBO 2 Assay (AC2 Assay)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01733069
NCT01733069N/ACompleted
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Clinical Evaluation of the APTIMA® COMBO 2®Assay Using the PANTHER™ System

Gen-Probe, Incorporated·observational·Posted Nov 26, 2012·Updated Jan 14, 2014

In Brief

An observational study evaluating APTIMA COMBO 2 Assay (AC2 Assay) for Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection. Completed, enrolled 1,912 participants across 7 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsChlamydia Trachomatis, Neisseria Gonorrhoeae Infection
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2012
Enrollment StartNov 1, 2010
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.6 years ago

Interventions

APTIMA COMBO 2 Assay (AC2 Assay)device

APTIMA COMBO 2 Assay (AC2 Assay