Diabetic Ketoacidosis Assay Collaboration Between Ortho Clinical Diagnostics and EKF Diagnostics

RARITAN, N.J. and CARDIFF, Wales, Oct. 11, 2017 /PRNewswire/ -- Ortho Clinical Diagnostics (Ortho), a global leader of in vitro diagnostics, and EKF Diagnostics (EKF) today announced an agreement that allows Ortho customers to access the Beta-Hydroxybutyrate (BHB) assay, an important marker used in conjunction with clinical findings and other lab tests for the diagnosis and management of ketoacidosis and its main causative factor, diabetic ketoacidosis (DKA). The high-quality, fully automated assay is now available for use on Ortho's VITROS^® 4600 Chemistry System and the VITROS^® 5600 Integrated System.

Diabetic ketoacidosis is a serious complication that can lead to a disruption of chemical balance in the body, and can be fatal if left undiagnosed. EKF's enzymatic Beta-Hydroxybutyrate (BHB) assay is used primarily for determining both the presence and degree of ketosis in suspected diabetic ketoacidosis cases. The BHB assay produces a quantitative value that is specific to the BHB 'ketone body'. These qualities make the BHB assay the new clinical diagnostic standard of care for ketone testing.

"Ortho is committed to delivering a broad menu of assays to our customers in the clinical lab, whether through in-house development or collaborations like the one with EKF," said Ortho's Chief Operating Officer Robert Yates.

Ortho and EKF are collaborating to provide the BHB assay as a validated MicroTip Partnership Assay (MPA) application in the U.S. and Canada. This MPA utilizes the User Defined Assay (UDA) feature, which provides the capability to program assay parameters as defined in the EKF- Stanbio Assay Application Sheet.  The Beta-Hydroxybutyrate LiquiColor^® assay has been CLIA classified by the U.S. Food and Drug Administration (FDA) as a MODERATE complexity assay on the VITROS^® 4600 Chemistry System and VITROS^® 5600 Integrated System.

"Diabetic ketoacidosis is a serious condition, and our collaboration with Ortho Clinical Diagnostics will help to deliver the important BHB assay to their existing customers," said EKF's Diagnostics Head of Sales, Gilbert Mejia.

EKF Diagnostics' Stanbio Chemistry portfolio is a broad range of liquid-stable reagents, calibrators, standards and controls. LiquiColor^® and Liqui-UV^® reagents are designed for maximum stability, ease-of-use and are optimized for today's chemistry analyzers. In addition to its BHB test for ketosis, EKF continues to build on its successful range of esoteric reagents.

About Ortho Clinical Diagnostics

Ortho Clinical Diagnostics is a global leader of in vitro diagnostics serving the global clinical laboratory and immunohematology communities. Across hospitals, hospital networks, blood banks, and labs in more than 125 countries and territories, Ortho's high-quality products and services enable health care professionals to make better-informed treatment decisions. Ortho brings sophisticated testing technologies, automation, and information management and interpretation tools to clinical laboratories around the world to help them run more efficiently and effectively and improve patient care. For the immunohematology community, Ortho's blood typing products help ensure every patient receives blood that is safe, the right type and the right unit. Ortho's purpose is to improve and save lives with diagnostics, and it does that by reimagining what's possible. This is what has defined Ortho for more than 75 years, and it's what drives Ortho forward. For more information, visit www.orthoclinicaldiagnostics.com.

About EKF Diagnostics

EKF Diagnostics is a leading point-of-care diagnostics and central laboratory assay manufacturer with an estimated 80,000 hemoglobin, hematocrit, HbA1c, glucose and lactate analyzers in regular use across more than 100 countries. The EKF manufactured Beta-Hydroxybutyrate reagent is used in a large number of hospitals in the USA and can be run on most open channel analyzers. 

EKF Central Laboratory: EKF, through its wholly owned subsidiary, Stanbio Laboratory (Boerne, Texas, USA), manufactures a comprehensive range of clinical chemistry reagents, rapid tests and benchtop chemistry analyzers. In addition, EKF Life Sciences (Elkhart, Indiana, USA) manufactures enzymes used in reagent development and also provides contract fermentation facilities. For more information, visit www.ekfdiagnostics.com.

© 2017 Ortho Clinical Diagnostics, © 2017 EKF Diagnostics

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SOURCE Ortho Clinical Diagnostics