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FDA Grants CLIA Waiver Expanding the Availability of Rapid Screening Test for Syphilis

The U.S. Food and Drug Administration today 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.

According to the U.S. Centers for Disease Control and Prevention (CDC), about 55,000 people in the United States are newly infected with syphilis annually. During the 1990s, syphilis primarily occurred among heterosexual men and women of racial and ethnic minority groups; during the 2000s, however, cases increased among men who have sex with men (MSM). Men who have sex with men accounted for 75 percent of all primary and secondary syphilis cases in 2012.

This sexually transmitted infection, caused by the bacterium Treponema pallidum, can cause long- term complications or increase the likelihood of HIV transmission if not adequately treated. The syphilis bacterium can also infect the fetus of a woman during her pregnancy, causing infant death, developmental delays and seizures. CDC recommends that all pregnant women be tested for syphilis at the first prenatal visit. Those 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. CDC also recommends screening at least once a year for syphilis for all sexually active homosexual, bisexual, and other men who have sex with men.

The FDA’s waiver is related to the Clinical Laboratory Improvement Amendments (CLIA), federal standards that apply to clinical laboratory testing on humans, with certain exceptions. Because the FDA granted a waiver under CLIA, the Syphilis Health Check test can be distributed to a variety of nontraditional laboratory sites, including physicians' offices, emergency rooms, maternity wards, 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 broader availability and easier access to this test should contribute to a higher rate of detection of syphilis infection,” said Alberto Gutierrez, Ph.D., director of the Office of In VitroDiagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health.

The test is performed by obtaining a sample of whole blood from a finger stick. Results are available in as little as 12 minutes and may be performed in the presence of the patient. All positive tests should be followed up with further 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 further lab testing. This increases the probability that patients, who might not return for a follow-up visit, will receive timely treatment.

The FDA first cleared the Syphilis Health Check test in 2011 and categorized it under CLIA as moderate- and high-complexity. The type of CLIA certificate a laboratory obtains depends upon the complexity of the tests it performs. CLIA regulations describe three levels of test complexity: waived tests, moderate complexity tests, and high complexity tests. The test was intended for use by prescription only to detect Treponema palladium antibodies in serum, plasma, and human whole blood.

The FDA granted a waiver under CLIA for the Syphilis Health Check test after the manufacturer submitted data demonstrating the test’s ease of use and accuracy. The agency reviewed data for finger sticks of whole blood samples from 417 subjects collected over the course of four months at three testing sites representing typical CLIA-waived sites, such as doctor’s offices. Twelve individuals not trained in the use of the Syphilis Health Check test performed the tests on the study subjects. Results showed that the Syphilis Health Check test, when used by untrained operators, performed with high accuracy. This is critical if the test is to be allowed for use outside of moderate- and high-complexity laboratories.

With the issuance of the waiver, the Syphilis Health Check test can be used by more laboratories as an initial screening test or in conjunction with other appropriate laboratory tests and clinical findings to aid in the diagnosis of syphilis infection. However, the test is not intended for use in screening blood or plasma donors.

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.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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