A vitamin D test from Ortho-Clinical Diagnostics Inc. has received the CE mark, the company announced. The VITROS Immunodiagnostic Product 25-OH Vitamin D Total Assay measures levels of vitamins D2 and D3 in human serum and plasma for use on certain automated platforms. The one-step immunoassay is approved for use on the VITROS ECi/ECiQ immunodiagnostic systems, the VITROS 3600 immunodiagnostic system, and the VITROS 5600 integrated system.

Lily Li, manager of scientific affairs for Ortho-Diagnostics, says lifestyle changes have reduced people’s exposure to the sun and caused “significant” growth in the level of vitamin D deficiency around the world. More than one billion people globally are estimated to suffer from the deficiency, she says. A proper amount of the vitamin promotes kidney, bone, and intestinal health. A blood test for 25(OH) vitamin D, a metabolite of the vitamin, is the most reliable indicator of vitamin D status. However, current testing methods that require manual operation are time-consuming and expensive, the company says.

 "As we understand more about the overall impact of vitamin D on human health, including its effects on skeletal and other disorders, healthcare providers are testing more patients for deficiency or insufficiency," says Reinhold Vieth, a professor in the departments of nutritional sciences and laboratory medicine and pathobiology at the University of Toronto. “Reliable and cost-effective testing methods are essential and can ultimately aid in better disease prevention and patient care management."

Ortho-Diagnostics also reports it recently filed a 510(k) premarket notification for the VITROS Immunodiagnostic Product 25-OH Vitamin D Total Assay and will be seeking additional regulatory approvals worldwide.