CAPE MAY COURT HOUSE, N.J., Sept. 14, 2015 /PRNewswire/ -- Diagnostics Direct, LLC., a leading provider of in-office rapid diagnostic tests, is pleased to announce the nation-wide adoption and use of the first and only FDA CLIA-Waived rapid treponemaI syphilis test: Syphilis Health Check in more than 250 state and local Public Health departments as well as ObGyns, Corrections facilities, university clinics and hospitals. The U.S. Food and Drug Administration granted the CLIA waiver for a rapid screening test for syphilis to Diagnostics Direct for their Syphilis Health Check on December 15, 2014.
“OBGYN’s throughout the country are now using the Syphilis Health Check test to screen newly-pregnant woman for Syphilis as part of their regular treatment protocol,” states Jeff Tobias, VP Sales & Marketing at Diagnostics Direct, LLC. He continues: “The U.S. Centers for Disease Control and Prevention (CDC) estimates that there are approximately 55,000 reported cases of syphilis in the United States annually; our CLIA-waived diagnostic test can provide early screening that can result in a higher rate of detection and the opportunity for immediate treatment.
Mr. Tobias continues, “We are focusing our initial marketing efforts on populations considered to be at high risk for syphilis and have found healthcare providers anxious to adopt use of Syphilis Health Check in order to better care for their patients.”
The Syphilis Health Check test 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 physician’s 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. 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. Controls are available separately.
About Diagnostics Direct, LLC.:
Founded in 2010 in Cape May Court House, NJ, Diagnostics Direct is an experienced provider of the latest, cutting edge CLIA-Waived diagnostic tests for Sexually Transmitted Diseases (STDs). Their diagnostics are easy to administer, simple to read, and highly accurate. For faster results and immediate patient care, rely on Diagnostics Direct. Visit www.diagnosticsdirect2u.com for more information or to request samples.
Contact for Diagnostics Direct, LLC.:Jeff Tobias, VP Sales & Marketing at (866) 358-9282
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/syphilis-health-check-gaining-nationwide-use-for-early-detection-of-syphilis-300142064.html
SOURCE Diagnostics Direct, LLC.
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