First-Ever FDA Waiver Expands Syphilis Test Availability

A rapid syphilis screening test will now be available in a greater number of health care settings, thanks to a first-ever waiver granted by the FDA.

The waiver is associated with the Clinical Laboratory Improvement Amendments (CLIA), which are federal standards that regulate clinical laboratory testing on humans. When the Syphilis Health Check test was first cleared by the FDA in 2011, it was categorized under CLIA as a moderate- and high-complexity test. This classification restricted the test’s availability to laboratories that were CLIA-certified to perform more complex tests.

The FDA granted the waiver under CLIA after the manufacturer demonstrated the test’s accuracy and ease of use. The agency reviewed blood sample data taken from 417 test subjects collected over the course of 4 months at 3 testing sites representing doctor’s offices and other typical CLIA-waived sites.

The tests were performed by 12 individuals who had not been trained on the use of the Syphilis Health Check test. The study results showed that the test performed with high accuracy when used by untrained operators.

The FDA’s waiver permits the Syphilis Health Check test to be distributed to a variety of nontraditional laboratory sites, including emergency rooms, maternity wards, health department clinics, and other freestanding counseling and testing sites. Additionally, the test can now be performed by untrained health care workers. As a result, it can be used as an initial screening test or in conjunction with other tests to aid in the diagnosis of syphilis, a sexually transmitted infection caused by the bacterium Treponema pallidum.

The Syphilis Health Check test screens for syphilis by analyzing a blood sample taken from a finger stick. The test results are available in as little as 12 minutes, allowing patients who test positive to receive timely treatment.

“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” said Alberto Gutierrez, PhD, director of the Office of In VitroDiagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, in a press release.