The FDA has granted a first-ever waiver for a rapid screening test for syphilis, allowing the test to be used in a greater variety of health care settings.
Early this week, the U.S. Food and Drug Administration (FDA) announced that it granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis, which will allow the Syphilis Health Check test to be used in a greater variety of health care settings.
About 55,000 new cases of syphilis occur each year in the United States, with 75% of primary and secondary cases occurring in men who have sex with men (CDC, 2012 data).
In women, the syphilis bacterium, Treponema pallidum, can also infect a fetus during pregnancy, causing infant death, developmental delays, and seizures. For this reason, the CDC recommends that all pregnant women be tested for syphilis at the first prenatal visit. Women who are at high risk, live in areas with high rates of syphilis, or were previously not tested should be tested in the third trimester and again at delivery.
By granting a waiver under the Clinical Laboratory Improvement Amendments (CLIA), the Syphilis Health Check test, first cleared in 2011, will now be available in nontraditional laboratory sites, such as physicians' offices, emergency departments, maternity units, other health care facilities, health department clinics, outreach sites, community-based organizations, and other freestanding counseling and testing sites. The waiver also allows untrained health care workers to perform the tests on patients. The test is not intended for use in screening blood or plasma donors, however.
“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.
A finger stick to obtain a sample of whole blood is required to perform the test. Results are available in as little as 12 minutes, allowing patients to wait for the result. All positive screening tests should be followed up with syphilis serological laboratory testing and clinical evaluation before final diagnosis. The rapid result means that if a patient tests positive, a health care worker can obtain a second blood sample at the same office visit to confirm the test results through additional lab testing, increasing the probability that patients, who might not return for a follow-up visit, will receive timely treatment.
The Syphilis Health Check test is manufactured by VEDA LAB of Alencon, France for Diagnostics Direct, LLC, based in Cape May Court House, NJ. It is also distributed by Trinity Biotech USA, Inc., of Jamestown, NY.