Card Offers Determination of an Individual’s Blood Type
REDMOND, Wash.--(BUSINESS WIRE)-- Micronics, Inc. (www.micronics.net), a medical device development company, today announced the commercial launch of a single-use, disposable blood typing device that makes it possible to quickly determine a person’s blood type and Rh status from a fingerstick of blood. Marketed as the ABORhCard—based on blood types A, B, AB, O, and Rh factor—the card serves as a “portable” test, eliminating the need for the instruments or other equipment, liquid typing reagents, and refrigeration traditionally used to determine a person’s blood group.
“The ABORhCard acts as a qualitative in vitro agglutination test that determines both the ABO blood group and Rh factor of an individual in approximately two minutes,” said Micronics president Karen Hedine. She noted that the U.S. Food and Drug Administration (FDA) has cleared the agglutination test as a 510 (k) Class II medical device for informational and educational purposes.
“While the test cannot be used for blood bank processing of blood products, for determining RHD status for the purpose of administration of Rh immunoglobulin, or for blood screening prior to transfusion, it offers significant benefits, such as informing individuals about their blood type prior to donating blood,” Hedine said. “We believe the ABORhCard is the first test of its kind to undergo extensive U.S. clinical trials.” She added that Micronics enrolled 1,700 volunteers in studies performed by three U.S. blood centers before submitting the 510(k) pre-market notification to the FDA’s Center for Biologics Evaluation and Research.
Developed in part under funding from the U.S. Army Medical Research and Materiel Command and the Telemedicine and Advanced Technology Research Center in Fort Detrick, Maryland, the ABORhCard meets the U.S. Army’s requirement for a field-deployable test of potential blood donors in austere settings where there are limited laboratory capabilities, and serves as a device to help manage large volumes of donors in contingency operations such as national emergencies, mobilization, or military combat operations.
About the ABORhCard
The ABORhCard is a single-use, disposable device that incorporates the necessary blood typing reagents and verification controls. It is the size of a credit card and does not require instruments or other equipment, liquid typing reagents or refrigeration. Additional features include long shelf life and waste containment in the card for easy disposal.
While other manual methods for blood typing are available, such products and methods generally either require liquid reagents that need refrigeration or they are used in an open environment, potentially subjecting the test to contamination. In comparison, the ABORhCard is a closed system that provides a user friendly, integrated test that produces a visible result in minutes following collection of a fingerstick sample of blood.
About Micronics, Inc.
Micronics, Inc., a Sony Group company, is a leading developer of near patient in vitro diagnostic products for disease diagnosis, prognosis and treatment monitoring. The Company employs a core patent estate in microfluidics—the ability to substantially reduce sample and reagent volumes – and to process all assay steps within closed system disposable devices for ease of use and safe disposal. Tests that today take hours in a central reference laboratory environment are processed in minutes on a Micronics disposable device. In addition to the ABORhCard, Micronics is advancing the PanNAT system for near patient point of care molecular diagnosis of infectious diseases.
©2012. Micronics, Inc. All rights reserved. ABORhCard is a registered trademark of Micronics, Inc. PanNAT is a trademark of Micronics, Inc. Patent Protected.
Source: Micronics, Inc.