The FDA granted the waiver under the Clinical Laboratory Improvement Amendments, the standards that apply to clinical lab testing on humans. Now, the Syphilis Health Check can be distributed to nontraditional lab sites, like physician offices, emergency rooms, maternity wards and community-based organizations, among other settings. Additionally, the waiver allows untrained healthcare workers to perform the tests.
“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 the FDA’s Center for Devices and Radiological Health.
The test involves a blood test from a finger stick, and results are available in 12 minutes.
According to the Centers for Disease Control and Prevention, about 55,000 people in the U.S. are newly infected with syphilis each year. The sexually transmitted infection can cause long-term complications and increase the likelihood of HIV transmission if not treated.
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