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Identigene STD Test Collection Kit Validation Study

NCT01471392 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3000

Last updated 2013-06-03

No results posted yet for this study

Summary

The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testing laboratory. It is expected that this method will aid in detection of CT and NG and that offering a method of self-collection of a male urine or female vaginal swab specimen will encourage testing for CT and NG and improve the overall detection of reporting of these STDs by allowing persons who suspect they have the infection to be tested in a discrete and confidential manner. The reporting of CT and NG are underestimated and many subjects will not visit a clinic or obtain treatment if gone undetected. Thus, allowing a self-collection kit that is more convenient may result in improved reporting, identification of CT and NG positive individuals, and subsequent treatment to help prevent the spread of these diseases.

The purpose of this study is to demonstrate that the Identigene STD Test Collection Kit and labeled instructions for use instructions provide test results that are concordant (at least 95% or better) with test results obtained using the Gen-Probe APTIMA Combo 2 specimen collection and transport methods performed under the supervision of a healthcare provider. The laboratory technology and test method used for the IDTG-100.

Conditions

Interventions

DEVICE

STD Diagnostic Kit (Identigene)

The Identigene STD Test Collection Kit is an at-home kit that allows individuals to utilize the Gen-Probe technology to test for CT and NG in privacy and in a more convenient manner. The primary technology is the approved Gen-Probe APTIMA Combo 2 assay, which is repackaged into the Identigene kit for use by consumers. As such, the laboratory technology and testing method is identical to that of the Gen-Probe APTIMA Combo 2 assay, which has been cleared for in vitro diagnostic use.

Sponsors & Collaborators

  • CRI Lifetree Clinical Research

    collaborator UNKNOWN

  • Identigene

    lead INDUSTRY

Principal Investigators

  • Mike Smith · Lifetree Clinical Research

  • Lars Mouritsen, PhD · Identigene

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01471392 on ClinicalTrials.gov