Biotest Diagnostics Corporation announces that it has received final clearance from the US Food and Drug Administration (FDA) to begin marketing its full line of traditional blood bank reagents in North America.
Intended for use by donor centers, reference laboratories and hospitals for blood group serology testing, these traditional blood bank reagents complement Biotest’s existing portfolio of automated reagents that work with its TANGOloptimo Automated Blood Bank System. The availability of these additional reagents afford customers more comprehensive choices.
“The ability to efficiently and accurately screen and type blood, as well as match patients and donors is critical, as are the tools we provide the blood banking industry,” said Bill Weiss, president, Biotest. “The approval of our traditional reagent line provides laboratory professionals with a vital alternative for their testing needs. Accessibility to more options at competitive prices is a significant offering in today’s competitive market. And, as a full-service supplier for laboratories’ complete blood typing and testing needs, Biotest is not only helping to strengthen the industry, but is also solidifying its unyielding commitment to customers and their patients.”
The traditional reagents that received FDA clearance include:
• Seraclone® Blood Grouping Reagents
• Biotestcell® Reagent Red Blood Cells
• Rare Typing Reagents
• Anti-Human Globulins
• Enhancement Reagents
• Control Sera and Red Cells
Biotest’s Reagent Red Blood Cell products include three configurations for antibody screening, two antibody identification panels, Coombs control cells and reverse ABO products. Rare typing reagents will include anti-C, anti-E, anti-c, anti-e, anti-Lea, anti-K, anti-k, anti-Fya, anti-Jka, anti-Jkb, anti-M, anti-N, anti-S, anti-s and anti-P1. All antisera are monoclonal and many of the clones have never been previously available in the US. Biotest’s reagents are recognized for their high levels of sensitivity and specificity.
Supporting its reagents and the TANGO|optimo, which features a newly expanded test menu that recently received FDA clearance, Biotest provides a 24/7 tech support hotline to ensure that its customers receive fast and knowledgeable answers to their questions. Biotest’s specially trained blood bank field staff—comprised of medical technologists with donor center and hospital transfusion service experience, and field service engineers with diagnostic industry experience—are on call and available to support implementation that is customized to meet the individual facility’s needs and provide fast and effective on-site troubleshooting.