Evaluation of the Atlas Genetics io® CTNG System

Binx Health Limited7,128 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

7,128

Conditions

Chlamydia Trachomatis Gonorrhea

Interventions

Atlas Genetics io® systemDEVICE

Specimen Collection

Eligibility

Sex: ALLMin age: 14 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (10)

University of Alabama

Birmingham, Alabama, United States

AIDS Healthcare Foundation

Los Angeles, California, United States

Indiana University

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices

The assessment of the diagnostic accuracy of the study device as compared to positive Composite Infected Status from comparator devices

Time frame: Up to 7 days

Data from ClinicalTrials.gov

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