Evaluation of the Atlas Genetics io® CTNG System



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:14 - Any
Updated:10/13/2018
Start Date:May 18, 2017
End Date:June 30, 2019
Contact:John Hladkiwskyj, B.Sc.
Email:john.hladkiwskyj@mybinxhealth.com
Phone:+44 1225 717932

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IO-CTNG: A Multi-Centre Evaluation of the Atlas Genetics io® CTNG System Used in Centralised and Point of Care Settings

Atlas Genetics io® system results are compared with those obtained from comparator devices.

Results from the Atlas Genetics io® system are compared with a Composite Infection Status
obtained from testing on three commonly used comparator devices.

This is a prospective, single-arm, multi-centre investigation enrolling up to 12,000 adult
participants over 14 years of age who are undergoing testing for the presence of CT/NG.

Inclusion Criteria:

1. Symptomatic and asymptomatic individuals ≥14 years of age

Exclusion Criteria:

1. Treatment with antibiotics known to be effective against Chlamydia trachomatis and/or
Neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study.

2. Unable to self-obtain a vaginal swab or urine sample of at least 30 mL
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Principal Investigator: LaShonda Crane, FNP
Phone: 713-831-6561
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3400 N Charles St
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