A screening test for syphilis that can produce results in 12 minutes has been granted a waiver, allowing it “to be used in a greater variety of health care settings,” including physician’s offices, the Food and Drug Administration announced on Dec. 15.
The Syphilis Health Check test, which uses a finger stick blood sample, was granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA) to allow it to be used outside of traditional laboratory settings. The approval was based on data “demonstrating the test’s ease of use and accuracy,” according to the statement. Other settings in which it can now be used include emergency departments, maternity wards, health department clinics, and community-based organizations and testing sites.
Health care workers without special training will be allowed to perform the test, the FDA said.
When the test was initially approved in 2011, it was categorized as “moderate and high complexity” under CLIA. The current waiver was granted based on data submitted by the manufacturer. Over 4 months, the test was used in 417 people at sites that have CLIA waivers, which included physician offices. The people performing the test were not trained, and the results were highly accurate.
If the test is positive, another blood sample should be obtained during the same visit and sent to a lab for serologic testing, and patients should be further evaluated before a final diagnosis is made, the FDA advised.
“The broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the statement.
About 55,000 people in the United States become infected with syphilis every year, and 75% of the primary and secondary syphilis cases in 2012 were among men who have sex with men, according to estimates from the Centers for Disease Control and Prevention.
The test is manufactured by a French company, VEDA LAB, for Diagnostics Direct, LLC, which is based in the United States.