Tuesday, March 30, 2021

Chlamydia and Gonorrhea Test Available for Wider Use

binx health io CT/NG is an easy to use test for chlamydia and gonorrhea that gives reliable results in about 30 minutes

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US Food and Drug Administration

FDA Grants CLIA Waiver to Allow First Point-of-Care Chlamydia and Gonorrhea Test To Be Used More Widely  

Today, the U.S. Food and Drug Administration (FDA) announced that a point-of-care test for chlamydia and gonorrhea may now be used in more health care settings including physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings operating under a CLIA Certificate of Waiver. The binx health io CT/NG Assay:

  • Gives results comparable to a laboratory-based test for chlamydia and gonorrhea in about 30 minutes rather than days or weeks.
  • Allows health care providers to provide diagnosis, a treatment plan, and counseling in a single patient visit.
  • Makes it easier for patients to get quicker test results and appropriate treatment.

This action is the result of the FDA granting a waiver under the Clinical Laboratory Improvement Amendments of 1988 ("CLIA") for the binx health io CT/NG Assay.

Learn More

Questions?

If you have questions about the new CLIA waived test, contact the Division of Industry and Consumer Education.


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