April 7, 2015
One Lambda, Inc. Announces the Availability of the Only FDA Cleared IVD Test for Detecting HNA-3
CANOGA PARK, Calif.--(BUSINESS WIRE)--One Lambda, Inc., part of Thermo Fisher Scientific and leading producer of in vitro diagnostic products for the HLA transplant community, today announced the availability of the only FDA cleared and CE marked assay for detecting HNA-3, as well as HLA. What’s more, the new LABScreen® Multi screening kit is capable of processing up to 96 samples in under 4 hours.
Both anti-HLA and anti-HNA antibodies have been implicated in the clinical cases of transfusion-related acute lung injury (TRALI). The new LABScreen® Multi antibody screening kit simultaneously detects HLA Class I, HLA Class II and HNA 1a, 1b, 1c, 2, 3a, 3b, 4a, 5a and 5b antibodies using the high-throughput Luminex® platform.
TRALI is a serious complication from blood transfusions that can cause pulmonary edema and is the leading cause of transfusion-related death. Several studies have implicated that TRALI may result from leukocyte and neutrophil antibodies in the transfused blood. This new product screens potential donors for antibodies to both HLA and HNA antigens at the same time.
The LABScreen® Multi assay is used to screen up to 96 donors for HLA and HNA all in one run. It’s easy to use, to interpret and, with the HLA Fusion software, data for both antigen groups is easy to analyze. Compared to conventional testing methods for neutrophil antibodies, the LABScreen® Multi assay offers an easy, efficient method for antibody screening. Launched at American Association of Blood Banks (AABB) in Philadelphia (October 25-28)
“TRALI is difficult to diagnose and treat,” said Dr. Karen Nelson, Co-Director and Clinical Consultant of the HLA Laboratory at Bloodworks Northwest (formally Puget Blood Center) in Seattle, Washington. “Transfusion centers need an assay that is FDA cleared, highly specific, able to detect antibodies to both HNA and HLA and automatable. The LABScreen® Multi kit from One Lambda meets these criteria.”
This bead-based assay is capable of processing up to 96 donors on a single plate in under 4 hours and multi plates can be processed simultaneously making it ideal for clinical labs processing large amount of samples. To learn more about LABScreen® Multi visit www.onelambda.com or call 818.449.3230.
About One Lambda
One Lambda, Inc., part of Thermo Fisher Scientific Inc., is the worldwide leader in HLA typing and antibody detection assays. One Lambda is known for its commitment to quality, service, and innovation. The company develops and distributes several lines of HLA typing and antibody detection tests utilizing serological, molecular, ELISA, Flow, and Luminex® technologies. In addition, One Lambda also manufactures laboratory instrumentation and computer software that are used to simplify and automate testing procedures and final test evaluations. For more information, please visit www.onelambda.com.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with revenues of $17 billion and approximately 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.