Evaluation of the Atlas Genetics io® CTNG System (IO-CTNG)

Binx Health

Status: Completed

Conditions: Gonorrhea; Chlamydia Trachomatis

Treatments: Device: Atlas Genetics io® system

Study type: Observational

Funder types: Industry

Identifiers

NCT03071510

MOB-VTP-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 7,128 patients

Sex: All

Ages: 14+ years old

Volunteers: Accepts Healthy Volunteers

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