Ortho Clinical Diagnostics, Raritan, NJ, and EKF Diagnostics, Cardiff, Wales, UK, have entered into an agreement that allows Ortho customers to access EKF’s Stanbio Chemistry LiquiColor assay for beta-hydroxybutyrate (BHB). This is 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. The fully automated assay is now available for use on Ortho’s Vitros 4600 chemistry system and Vitros 5600 integrated system.
Diabetic ketoacidosis is a serious complication that can lead to a disruption of the body’s chemical balance, and can be fatal if left undiagnosed. EKF’s enzymatic BHB assay is used primarily for determining 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,” says Ortho’s COO, Robert Yates.
FDA has classified the LiquiColor BHB assay performed on the Vitros 4600 or Vitros 5600 systems as a moderate-complexity test under the terms of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
“Diabetic ketoacidosis is a serious condition,” says Gilbert Mejia, head of sales at EKF Diagnostics. “Our collaboration with Ortho Clinical Diagnostics will help to deliver the important BHB assay to their existing customers.”
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 and 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.