Identigene STD Test Collection Kit Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01471392
Recruitment Status : Unknown
Verified May 2013 by Identigene.
Recruitment status was:  Recruiting
First Posted : November 15, 2011
Last Update Posted : June 3, 2013
CRI Lifetree Clinical Research
Information provided by (Responsible Party):

Brief 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.

Condition or disease Intervention/treatment Phase
Infection Device: STD Diagnostic Kit (Identigene) Phase 3

Detailed Description:

This is a multicenter study involving asymptomatic and symptomatic subjects who are at risk or suspect possible exposure to CT and/or NG. Approximately five (5) clinics will participate in the study. The clinics selected will be located in diverse geographical regions in order to represent populations with both high and low incidences of CT and NG and to represent different extremes in climate. The initial phase of the study enrolled approximately 500 qualifying subjects. An interim analysis was performed to determine whether changes in the study protocol were necessary. Changes to the protocol were identified and are incorporated in this amendment (amendment 4) of the study protocol. Specifically, males in the study will still collect urine specimens whereas women will now self-collect a vaginal swab specimen. Study subjects will only undergo one clinic visit rather than two as indicated in prior versions of the study protocol. The proposed study phases outlined in this amendment of the study protocol will include at least 200 qualifying subjects with intermittent suspension of the study to allow data analysis. The present study will continue until 200 CT positive test results (approximately 100 male and 100 female) are obtained. Of these 200 positive results, approximately 50% will be from symptomatic subjects and 50% from asymptomatic subjects. Since the positivity rate is presumably lower for asymptomatic subjects, the ration of symptomatic to asymptomatic subject enrollment for each study phase will be determined by the sponsor and will be made known in writing to each study site.

It is expected that approximately 3,000 subjects will be required to meet the overall study objectives. It is anticipated that the total number of subjects enrolled for testing throughout the study will yield approximately 30 positive NG samples (approximately 15 males and 15 females) with no requirement for a specific ratio of symptomatic to asymptomatic subjects. Subjects who are at high risk of exposure or suspect exposure to CT or NG, but are not currently being treated, will be recruited for enrollment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Identigene STD Test Collection Kit Validation Study
Study Start Date : November 2011
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: Identigene STD Test Kit Arm
Single-Arm trial where the group will complete the Identigene STD Test Kit at home and these results will be compared with the results from testing in the clinic with the Gen-Probe APTIMA kit. The subject will only be informed of the results from the approved test (Gen-Probe APTIMA) that is done in the clinic.
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.
Other Name: Identigene STD Test Collection Kit

Primary Outcome Measures :
  1. Effectiveness of the Identigene STD Test Collection Kit in comparison to the Gen-Probe Aptima Combo 2 Assay [ Time Frame: 1 day ]
    Demonstration of the effectiveness of the Identigene STD Test Collection Kit based on the percentage of concordant positive and negative results as compared to the Gen-Probe APTIMA Combo 2 assay conducted at an STD clinic.

Secondary Outcome Measures :
  1. Evaluation of the Identigene STD Test Collection Kit instructions. [ Time Frame: 1 day ]
    To determine if the instructions of the Identigene STD Test Collection Kit are adequate for proper specimen self-collection and specimen submission to the laboratory for processing.

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. 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
  2. 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.),
  3. Individuals who are capable of understanding and agree to fulfill the requirements of the protocol.
  4. Individuals who have signed the IRB approved informed consent form.

Exclusion Criteria:

  1. 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,
  2. 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
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01471392

Contact: Michael Smith 801-859-7818

United States, Maryland
John Hopkins University Recruiting
Baltimore, Maryland, United States
Contact: Charlotte Gaydos, MD    410-614-0932   
Contact: Patricia Buist    410-614-0932   
Principal Investigator: Charlotte Gaydos, MD         
Sponsors and Collaborators
CRI Lifetree Clinical Research
Study Director: Mike Smith Lifetree Clinical Research
Study Chair: Lars Mouritsen, PhD Identigene

Additional Information:
Responsible Party: Identigene Identifier: NCT01471392     History of Changes
Other Study ID Numbers: IDTG-100
First Posted: November 15, 2011    Key Record Dates
Last Update Posted: June 3, 2013
Last Verified: May 2013

Keywords provided by Identigene:
STD Test
Sexually Transmitted Disease