CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
September 2019—Ortho Clinical Diagnostics announced that its Vitros Immunodiagnostic Products HIV Combo Reagent Pack and Calibrator (Vitros HIV Combo test) has been granted FDA premarket approval for use on Ortho’s Vitros XT 7600 Integrated System. The Vitros HIV Combo is a fourth-generation test that detects HIV-1 and HIV-2 antibodies and the p24 antigen.
The company announced in July the CE marking of an enhanced version of its Vitros NT-proBNP II assay, designed as an aid in diagnosing heart failure and for the risk stratification of acute coronary syndrome and heart failure. It is further indicated as an aid in the assessment of increased risk of cardiovascular events and mortality in patients who have stable coronary artery disease and in the assessment of heart failure severity in patients diagnosed with heart failure.