FDA Grants Waiver for Rapid-Screening Syphilis Test

Rapid Syphilis Test

Physicians offices, emergency rooms, maternity wards, health department clinics, outreach sites, community clinics and other freestanding testing and counseling sites should soon have access to the Syphilis Health Check test, a rapid-screening test for syphilis. On December 15, 2014, the FDA approved a Clinical Laboratory Improvement Amendments waiver for the test, which provides these other sites with the ability to obtain the test without a doctor’s prescription and enables health care workers to administer the test without receiving special training.However, all facilities that administer the test are required by law to report the names of patients who test positive for syphilis to the state health department.

With a sample of blood from a finger stick, test results can be available in as little as 12 minutes, eliminating the need for a follow-up visit to receive test results and a treatment plan. While a doctor will take a further sample of blood and send it to the laboratory to confirm positive test results, those patients who might not have returned for a follow-up visit to learn about test results will receive a diagnosis and  treatment during a single visit .

The FDA assigns one of three categories to a laboratory test: waived, moderate complexity and high complexity. The Syphilis Health Check test had previously been categorized as a moderate- and high-complexity test, and was only available with a doctor’s prescription. The manufacturer provided information to the FDA that demonstrated how easy it is to administer the test. The company also submitted data from three testing sites where health care workers not specifically trained on the SHC tested a total of 417 people over a period of four months. The data showed that the test results were extremely accurate.

Syphilis is caused by the Treponema pallidum bacterium. Syphilis infections are on the rise, especially among men who have sex with men, and it appears to make HIV infection easier if not treated. Syphilis is called the great imitator because its symptoms mimic the symptoms you might experience with other common ailments, such as the common cold, and go away on their own. However, unless treated, the infection does not go away and can cause serious medical problems, including death.

The health care and community facilities that gain access to the SHC test are required by law to report your name and other personal information to the state health department when you test positive for syphilis. Don’t let the fear of exposure prevent you from getting tested and getting treatment! Follow our free guide and find out how to get a truly anonymous test for syphilis.

For more information, read the FDA news release.

 

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