A rapid screening test for syphilis has been approved for use in a wider variety of health-care settings, including provider offices and clinics, according to a new release from the United States Food and Drug Administration (FDA).
About 55,000 patients in the United States are newly infected with syphilis each year, according to the United States Centers for Disease Control and Prevention (CDC). In 2012, men who have sex with men (MSM) accounted for 75% of all primary and secondary syphilis cases.
When left untreated, syphilis infection can cause long-term complications or increase the risk of human immunodeficiency virus (HIV) transmission. The syphilis bacterium, Treponema pallidum, can also infect the fetus of a woman during her pregnancy, causing infant death, developmental delays, and seizures.
The Syphilis Health Check test can be distributed to nontraditional laboratory sites, including provider’s offices, emergency rooms, maternity wards, and other health-care facilities. The waiver also allows untrained health-care workers to perform the tests on patients.
“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.
A whole blood sample is obtained from a finger stick, and results are available in as little as 12 minutes. All positive tests should be followed up with further syphilis serological laboratory testing and clinical evaluation before final diagnosis, noted the agency.
The Syphilis Health Check test is manufactured by VEDA LAB of Alencon, France for Diagnostics Direct, LLC, based in Cape May Court House, New Jersey. It is also distributed by Trinity Biotech USA, Inc., of Jamestown, New York.