Ortho Clinical Diagnostics has received CE mark approval for its new diagnostic blood test, Vitros Immunodiagnostic Product 25-OH Vitamin D Total assay.
The Vitros 25-OH Vitamin D Total assay is an one-step immunoassay designed to use on Vitros ECi/ECiQ Immunodiagnostic Systems, the Vitros 3600 Immunodiagnostic System, and the Vitros5600 Integrated System.
The results of 25-OH Vitamin D Total assay are used in the evaluation of vitamin D sufficiency and may be used in conjunction with other clinical or laboratory data to assist the clinician in patient management.
The assay in addition has a time to first result of 24 minutes which allows for improved timeliness of result reporting for higher-volume customers.
Ortho Clinical Diagnostics scientific affairs manager Lily Li said, "With CE Marking of the fully-automated VITROS Immunodiagnostic Product 25-OH Vitamin D Total Assay, OCD can now offer European customers a vitamin D test that provides equal detection of vitamin D2 and D3 for a more accurate evaluation of the patient’s overall vitamin D status."
Recently, OCD filed a 510(k) application of Vitros 25-OH Vitamin D Total assay to the US Food and Drug Administration, which is still in pending approval.