The Food and Drug Administration (FDA) has cleared the binx health io Instrument CT/NG Assay for point of care use to test for chlamydia and gonorrhea in health care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
The testing platform provides results in about 30 minutes, allowing clinicians to diagnose and treat the infections faster. The test uses female vaginal swabs and male urine specimens to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae using proprietary highly sensitive electrochemical detection technology. The performance of the test was found to be comparable to tests run in CLIA certified laboratories that meet the requirements for high or moderate complexity testing.
“The io Instrument’s demonstrated clinical effectiveness, ease of operation, and patient convenience make it a much-needed tool with transformative implications for public health, especially now during the COVID-19 pandemic where STI prevention services nationwide have been dramatically reduced or cut altogether as resources have been allocated to focus on the COVID response,” said Jeffrey Luber, binx Chief Executive Officer.
For more information visit mybinxhealth.com.
1. FDA Allows for First Point-of-Care Chlamydia and Gonorrhea Test to be Used in More Near-Patient Care Settings. [press release]. Silver Spring, MD: Food and Drug Administration; March 30, 2021.
2. Binx Health receives FDA CLIA waiver for chlamydia and gonorrhea test, expanding critical access to single-visit diagnoses. [press release]. Boston, MD: binx health; March 30, 2021.