Laboratory Question for the Week of July 5, 2021

Question:

Is it true the FDA authorized the first STD testing for point of care settings to be used for more near-patient care settings?

Answer:

Yes, this spring, the U.S. Food and Drug Administration (FDA) granted authorization for the utilization of the Binx Health IO CT/NG Assay at point-of-care settings to aid in the detection and diagnosis of two sexually transmitted diseases, chlamydia, and gonorrhea. More specifically, these settings encompass physician offices, community-based clinics, urgent care settings, outpatient health care facilities, and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. The outcome occurred because the FDA allowed for a waiver under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”) for the Binx Health IO CT/NG Assay.

This question was answered in an edition of our Laboratory Compliance Manager. For more hot topics relating to laboratory services, please visit our store or call us at 1.800.252.1578, ext. 2.