The Food and Drug Administration (FDA) has granted the first-ever waiver under specific laboratory regulation for Syphilis Health Check test to be used in expanded healthcare settings.
The Syphilis Health Check test, a rapid screening test for syphilis, was first cleared by the FDA in 2011. The waiver was granted after data supporting the test’s usability and accuracy. Finger sticks of whole blood samples from patients collected over 4 months (n=417) were reviewed. The test was performed 12 workers not trained in the use of the Syphilis Health Check test. Results demonstrated that the test provided high accuracy even when used by untrained workers.
The FDA’s waiver under the Clinical Laboratory Improvement Amendments (CLIA) now allows the Syphilis Health Check test to be distributed to a wider range of nontraditional laboratory sites such as physicians’ offices, emergency rooms, maternity wards, other healthcare facilities, health department clinics, outreach sites, community-based organizations, and other stand-alone counseling and testing sites. Also, untrained healthcare workers are able to perform the tests on patients under this FDA waiver.
The finger stick test provides results as fast as 12 minutes. If a patient tests positive, a healthcare worker can take a second blood sample during the same office visit to further confirm the test results.
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