Evaluation of the Atlas Genetics io® CTNG System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

7128 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-18

Study Completion Date

2019-08-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Chlamydia Trachomatis Gonorrhea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Atlas Genetics io® system

Specimen Collection

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes