Infectious Disease

FDA clears point-of-care test for chlamydia, gonorrhea

The Food and Drug Administration (FDA) has approved the binx health io Instrument CT / NG test for use at the point of care to test for chlamydia and gonorrhea in healthcare facilities operated under a CLIA waiver certificate, certificate of conformity, or certificate of accreditation .

The test platform provides results in around 30 minutes, so doctors can diagnose and treat 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 high-sensitivity electrochemical detection technology. The test’s performance was found to be comparable to tests performed in CLIA-certified laboratories that meet the requirements for high or medium complexity tests.

“The proven clinical efficacy, ease of use and patient friendliness of the io Instrument make it a much-needed tool with transformative public health implications, especially now during the COVID-19 pandemic, which is dramatically reducing or eliminating STI prevention services across the country Resources have been allocated to focus on the COVID response, “said Jeffrey Luber, binx’s chief executive officer.

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1. The FDA allows the first-site chlamydia and gonorrhea test to be used in patient-centered care settings. [press release]. Silver Spring, MD: Food and Drug Administration; March 30, 2021.

2. Binx Health Receives FDA CLIA Exemption for Chlamydia and Gonorrhea Testing, Expanding Critical Access to Single Visit Diagnostics. [press release]. Boston, MD: binx health; March 30, 2021.

This article originally appeared on MPR


Bacterial Infections Diagnostic Tests Infectious Diseases Obstetrics and Gynecology Urological Disorders

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