Diabetic ketoacidosis assay collaboration between Ortho Clinical Diagnostics and EKF

Ortho Clinical Diagnostics (Ortho), a global leader in in vitro diagnostics, and EKF Diagnostics (EKF) today announced an agreement that allows Ortho customers to access the Beta-Hydroxybutyrate (B-Hb) LiquiColor® assay. This critical marker is used in conjunction with clinical findings and other lab tests to diagnose and manage ketoacidosis and its main causative factor, diabetic ketoacidosis (DKA). The high-quality, fully automated assay is now available 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 LiquiColor® assay is used primarily to determine the presence and degree of ketosis in suspected diabetic ketoacidosis cases. The B-Hb assay produces a quantitative value specific to the B-Hb ‘ketone body .’ These qualities make the B-Hb 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 collaborate to provide the Beta-Hydroxybutyrate LiquiColor® 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 can program assay parameters defined in the EKF- Stanbio Assay Application Sheet. The B-Hb 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. This new MPA will only be available for Ortho analyzers in the USA and Canadian markets.

“Diabetic ketoacidosis is a serious condition, and our collaboration with Ortho Clinical Diagnostics will help to deliver the important B-Hb assay to their existing customers,” said EKF’s Diagnostics Head of Sales, Gilbert Mejia.

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