Diagnostics Direct, LLC., a leading provider of in-office diagnostic tests, is pleased to announce the launch of the first CLIA-Waived rapid treponemal syphilis test: Syphilis Health Check™. The U.S. Food and Drug Administration granted the first-ever waiver, under certain laboratory regulations, for a rapid screening test for syphilis to Diagnostics Direct for their Syphilis Health Check test for use in a greater variety of health care settings.
"The U.S. Centers for Disease Control and Prevention (CDC), estimates that there are approximately 55,000 reported cases in the United States annually; our CLIA approved diagnostic test, Syphilis Health Check, can provide effective screening that should contribute to a higher rate of detection," states Jeff Tobias, VP Sales & Marketing at Diagnostics Direct, LLC. He continues: "Syphilis Health Check is performed by using a sample of whole blood from a finger stick with results available in as little as 12 minutes. The test can be performed while the patient is in the office. If a patient tests positive with Syphilis Health Check, the health care provider can immediately obtain a second sample during the same visit for a confirmatory test using traditional nontreponemal testing."
With the issuance of the CLIA waiver, Syphilis Health Check can be used by more healthcare providers, including untrained health care workers. Each Syphilis Health Check test kit contains everything required to conduct 20 tests including: 20 test devices; 20 fixed volume plastic pipettes; Diluent in a dropper bottle containing saline buffer, detergent and sodium azide (NaN3< 0.1%) - 5 ml; Package Insert Instructions and a Quick Reference Guide.