Identigene STD Test Collection Kit Validation Study

Status unconfirmed · Phase 3

Conditions studied: Infection

In brief

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.

Key facts

Study ID

NCT01471392

Run by

Identigene

People needed

3000

Starts

2011-11-01

Expected to finish

2014-06-01

Last updated by the study team

2013-06-03

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Symptomatic females or males, age 14 or older, who present at a participating clinic with symptoms consistent with Chlamydia trachomatis or Neisseria gonorrhoeae infection, or
• Asymptomatic females or males, age 14 or older, who present at a participating clinic and who suspect that they have CT and/or NG, or are considered at high risk of exposure (e.g., sexual partner that tests positive for CT, or NG, multiple sexual partners, ect.),
• Individuals who are capable of understanding and agree to fulfill the requirements of the protocol.
• Individuals who have signed the IRB approved informed consent form.

You may not qualify if…

• Individuals with physical or mental inability that, in the opinion of the investigator can interfere with the subject's ability to follow the Identigene STD Test Collection Kit instructions,
• Individuals who are currently being treated for CT or NG or who are currently receiving antibiotics or have received antibiotics within the last 28 days, and
• Individuals who are suspected of being victims of sexual abuse or nonconsensual contact of a sexual nature within the previous 6 months or who are part of an ongoing sexual abuse legal case.

Where it is running

• John Hopkins University — Baltimore, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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