FDA grants first-ever CLIA waiver of rapid syphilis test

FDA has granted the first-ever CLIA waiver for the Syphilis Health Check test, a rapid screening test for syphilis.

Syphilis is a sexually transmitted infection caused by the bacterium Treponema pallidum, which can cause long-term complications and increase the likelihood of HIV transmission if not treated properly. Syphilis can also seriously complicate pregnancy and result in spontaneous abortion, developmental delays, or seizures.

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Currently, the CDC recommends syphilis screening at least once a year for all sexually active men who have sex with men, as this group accounts for about 75% of all primary and secondary syphilis cases. The CDC also encourages all pregnant women to be screened at their first prenatal visit, while those at high risk or who were not previously tested should be tested in the third trimester and again at delivery.

The Syphilis Health Check test is a finger-stick blood test that allows rapid results within 12 minutes. The test may be performed in the presence of the patient, and the speed of the test allows a second blood sample to be obtained at the same office visit to confirm any positive results through further lab testing.

The type of Clinical Laboratory Improvement Amendments (CLIA) certificate that a laboratory obtains depends upon the complexity of the tests it performs. FDA had originally designated the test as moderate- and high- complexity, in 2011, meaning that it could only be performed in a qualified lab. The agency has now waived that requirement, making it available in a variety of settings, including physicians’ offices, emergency rooms, maternity wards, and other healthcare facilities. The waiver also allows untrained workers to perform the tests on patients.

 The FDA granted the waiver after the manufacturer, VEDALAB of Alecon, France, submitted data demonstrating the test’s ease of use and accuracy. Data results showed that the Syphilis Health Check test, when used by untrained operators, performed with high accuracy.

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

Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.