Ortho Clinical Diagnostics and EKF Diagnostics Collaborate for Assay

Ortho Clinical Diagnostics (Raritan, NJ, USA) and EKF Diagnostics (Wales, UK) have entered into 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 fully automated assay is now available for use on Ortho's VITROS 4600 chemistry system and the VITROS 5600 integrated system.

Ortho’s in vitro diagnostics products and services for the clinical laboratory and immunohematology communities include blood typing products, sophisticated testing technologies, automation, information management and interpretation tools. EKF Diagnostics, through its wholly owned subsidiary, Stanbio Laboratory, manufactures a comprehensive range of clinical chemistry reagents, rapid tests and benchtop chemistry analyzers. EKF Diagnostics' enzymatic BHB assay is used primarily for determining both the presence and degree of ketosis in suspected DKA cases and produces a quantitative value that is specific to the BHB “ketone body.”

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

"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.

"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.