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Abbott Receives CE Marks for Screening, Dx Systems

NEW YORK (360Dx) – Abbott Laboratories said today that it has received CE marking for its Alinity s system for blood and plasma screening and, separately, for its Alinity ci-series instruments for clinical chemistry and immunoassay diagnostics.

The blood and plasma screening, clinical chemistry, and immunoassay diagnostics systems are now available in Europe and other countries that recognize the CE mark, Abbott said.

The firm added that the Alinity s test system is designed to screen blood and plasma faster, more efficiently, and within a smaller footprint than Abbott's current systems. Lab professionals can run up to 600 tests per hour, twice as many as are possible using standalone instruments, and experience walk-away time — when they can manage other activities — of up to three hours.

The Alinity s is "a significant leap forward" when it comes to speed, automation, and efficiency, which is important to improving productivity in blood and plasma services of all sizes, Louis Morrone, general manager for Abbott's Transfusion Medicine business, said in a statement.

Similar to the blood and plasma screening system, Abbott's clinical chemistry and immunoassay systems offer greater capacity in a smaller footprint, the company said.

Lab professionals can operate the newly CE-marked clinical chemistry and immunoassay systems separately or as an integrated Alinity ci-series unit. Its clinical chemistry tests detect the presence of chemicals in the blood and include tests such as sodium, potassium, glucose, and calcium. Immunoassay methods use antibody or antigen recognition to detect complex molecules and provide information related to infectious diseases, hormone levels, cardiac risk factors, cancer, thyroid issues, and therapeutic drugs.

Lab professionals using Alinity ci get greater loading capacity for samples and tests, and they can access separate lanes to run urgent tests without interrupting lab workflow, according to Abbott.

The firm said that it will launch clinical chemistry and immunoassay tests for the Alinity ci-series in phases, and that a complete menu of tests will be available within a year of launch.

Abbott's announcement today comes on the heels of receiving CE marking for its i-STAT Alinity handheld blood testing platform in November 2016. The platform performs blood tests on a single device, including analysis of blood chemistries and cardiac markers, using around three drops of blood.

"This is an unprecedented time within our broader Alinity family in terms of the variety and number of instruments that we are developing and bringing to the market," Matt Bates, divisional vice president of R&D for Abbott's point-of-care business, said recently in an interview.