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

NCT01733069 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1912

Last updated 2014-01-14

Study results available
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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.

Conditions

  • Chlamydia Trachomatis
  • Neisseria Gonorrhoeae Infection

Interventions

DEVICE

APTIMA COMBO 2 Assay (AC2 Assay)

APTIMA COMBO 2 Assay (AC2 Assay

Sponsors & Collaborators

  • Gen-Probe, Incorporated

    lead INDUSTRY

Principal Investigators

  • Jennifer Reid, PhD · Gen-Probe, Incorporated

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-02-29
Completion
2012-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01733069 on ClinicalTrials.gov