Novel Device That Enables Blood Collection Anytime and Anywhere Listed with the FDA

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A device that makes it faster and more convenient to collect and process blood samples has been registered by the U.S. Food and Drug Administration (FDA) as a Class 1 Medical Device.

Novilytic, a life sciences company located in the Purdue Research Park of West Lafayette, Indiana, has developed the Noviplex™ Plasma Collection Card. The card-shaped device collects drops of blood and separates out the plasma without the need for any laboratory equipment. The device received a 2014 R&D 100 Award from the editors of R&D magazine.

Class 1 Medical Device designation permits medical diagnostic companies to use the device for plasma samples collected by doctors and others in medical facilities.

“The award-winning Noviplex card is the first major advance in blood collection in over 50 years,” said Fred Regnier, the John H. Law Distinguished Professor of Chemistry in Purdue’s College of Scienceand CEO of Novilytic. “For the first time, the chemical factories called red blood cells can be prevented from changing the chemical composition of the sample right at the time of blood collection. Noviplex cards effortlessly and consistently produce a stable plasma sample without the need for centrifugation.”

Traditional plasma sampling methods produce liquid samples and require expensive transportation, storage and processing.

The Noviplex Plasma Collection Card combines blood collection, plasma fractionation, sample preservation, transportation and sample preparation into a single step.

As plasma travels through a three-membrane stack, the technology separates and filters plasma from blood cells. It does not require any power source and can be used anywhere.

The card works with either fresh or chilled blood.  Depending on the device’s configuration, it can collect three to six microliters of plasma. Testing has shown the device removes at least 99 percent of blood cells.

The Noviplex card collects plasma in two to three minutes, and the result is ready for shipment in about 10 minutes. The Noviplex plasma samples are stable for a week or more. No ice or other coolants are required for shipping the sample.