Identigene STD Test Collection Kit Validation Study

NCT01471392 | Unknown Phase 3

• 1 other identifier: IDTG-100
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Infection

Keywords

Identigene; STD Test; Chlamydia; Gonorrhoeae; APTIMA; Sexually Transmitted Disease

Outcome Measures

Primary Outcomes (1)

• Effectiveness of the Identigene STD Test Collection Kit in comparison to the Gen-Probe Aptima Combo 2 Assay

  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.

  1 day

Secondary Outcomes (1)

• Evaluation of the Identigene STD Test Collection Kit instructions.

  1 day

Study Arms (1)

Identigene STD Test Kit Arm

EXPERIMENTAL

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)

Interventions

STD Diagnostic Kit (Identigene) DEVICE

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.

Also known as: Identigene STD Test Collection Kit

Identigene STD Test Kit Arm

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Identigene: lead
• CRI Lifetree Clinical Research: collaborator

Study Sites (1)

John Hopkins University

Baltimore, Maryland, United States

RECRUITING

MeSH Terms

Conditions

Infections; Chlamydia Infections; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Chlamydiaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Sexually Transmitted Diseases, Bacterial; Communicable Diseases; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mike Smith

  Lifetree Clinical Research

  STUDY DIRECTOR

• Lars Mouritsen, PhD

  Identigene

  STUDY CHAIR

Central Study Contacts

Michael Smith

CONTACT

801-859-7818; mikes@lifetreeresearch.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2011
• First Posted: November 15, 2011
• Study Start: November 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 3, 2013

Record last verified: 2013-05

Locations

US (1)