Sekisui Diagnostics Launches CE Marked, Novel, Fully Automated Syphilis Assays

LEXINGTON, Massachusetts, Sept. 28, 2016 /PRNewswire/ — Today, Sekisui Diagnostics announces the launch of its new SEKURE® TPLA and RPR assays for Syphilis testing. The SEKURE® TPLA and RPR reagents are fully automated, quantitative latex immunoturbidimetric assays that may be used as an aid in the screening and treatment monitoring of Syphilis. The ability to automate both these assays on a chemistry system provides a highly differentiated option for laboratories looking for both automation and efficiency. These tests are an exciting addition to the broad range of clinical chemistry products that Sekisui Diagnostics offers under the SEKURE® brand.

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Syphilis is a chronic infection caused by the spirochete bacterium Treponema pallidum, which can be transmitted both congenitally and by sexual contact.  It is estimated there are 10 million new cases of syphilis every year on a global basis.  A reportable disease in many countries, syphilis diagnosis requires both screening and confirmatory testing, along with clinical signs and assessment. The SEKURE® TPLA and RPR assays are both fully automated making them ideal for screening purposes.  Various testing algorithms are used in different countries, and the SEKURE® assays can be helpful in managing the process flow through these algorithms.

“Consistent with our commitment to continuous development of tests that can help improve patient care, the new SEKURE® Syphilis tests offer the potential to streamline testing and help reduce the need for labor intensive, manual testing,” says Lee Lipski, Vice President Global Sales and Marketing. “We believe that the availability of these new tests will benefit both laboratories and patients worldwide.”

The SEKURE® TPLA and RPR assays can be run on the same clinical chemistry platform, including the SK™ 500 Chemistry System (as well as some other platforms), allowing for rapid reflex testing of multiple test samples. The tests are convenient and efficient with a 10 minute turnaround time and results that correlate with traditional methods (TPHA/ RPR Card test).  In addition, the RPR test is standardized to the WHO International Standard for Syphilitic Human Serum,* which will aid in standardizing results. The RPR results are quantitative, providing a tool to aid physicians in treating syphilis and monitoring therapy.

About Sekisui Diagnostics
Sekisui Diagnostics is a global diagnostics company committed to improving patient lives by providing innovative medical diagnostic products to physicians and laboratories, as well as diagnostics manufacturers through a global distribution network. Product lines include clinical chemistry and coagulation systems and reagents, infectious disease testing, point-of-care immunoassay systems and rapid test kits, as well as enzymes and specialty bio-chemicals.

Visit Sekisui Diagnostics at www.sekisuidiagnostics.com for more information on products and services.

*WHO International Standard. The International Standard for Syphilitic Human Serum (1st international standard preparation), established in 1958

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