Rapid Screening Test for Syphilis Granted CLIA Waiver

A qualitative rapid membrane immunochromatographic assay for the detection of Treponema pallidum (syphilis) antibodies in human whole blood, serum or plasma has been granted a Clinical Laboratory Improvement Amendments (CLIA) waiver.

Because of the CLIA waiver, the 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 US Food and Drug Administration (FDA; Silver Springs, MD, USA) granted a waiver under CLIA for the syphilis 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 (VEDA LAB; Alencon, France) 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. 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.

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. Although the test is manufactured in France it is distributed by Diagnostics Direct, LLC (Cape May Court House, NJ, USA) and also by Trinity Biotech USA, Inc. (Jamestown, NY, USA).

Related Links:
US Food and Drug Administration
VEDA LAB  
Diagnostics Direct, LLC