Chlamydia Trachomatis, Gonorrhea
Conditions
Brief summary
Atlas Genetics io® system results are compared with those obtained from comparator devices.
Detailed description
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.
Interventions
DEVICEAtlas Genetics io® system
Specimen Collection
Sponsors
Binx Health Limited
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic Accuracy compared to positive Composite Infected Status from comparator devices | Up to 7 days | The assessment of the diagnostic accuracy of the study device as compared to positive Composite Infected Status from comparator devices |
Countries
United States
Outcome results
None listed