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