The Architect 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. It is recommended that the Architect 25-OH Vitamin D assay, which is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma, when used for diagnostic purposes, should be used in conjunction with other data; e.g., symptoms, results of other tests, clinical impressions, etc.

Each laboratory should establish its own reference range, which may be unique to the population it serves depending upon geographical, season, patient, dietary, or environmental factors. The product contains human sourced and/or potentially infectious components. The reagents and human specimens must be handled in accordance with the OSHA Standard on Bloodborne Pathogens.

Abbott (Abbott Park, IL, USA) has received US Food and Drug Administration (FDA; Silver Spring, MD, USA) clearance for the fully-automated 25-OH Vitamin D assay performed on its widely used Architect laboratory testing platform.

Less than a quarter of Americans have the minimal vitamin D levels necessary for general health benefits. There are a number of factors that may contribute to people having low vitamin D, including low dietary intake, sun avoidance, geographic location, age, and ethnicity.

Low vitamin D can cause skeletal disorders, such as rickets in children and bone loss in adults, and has been linked to an increased risk of hip fractures. Although research is still being conducted in this area, some studies have shown that people with a low level of vitamin D may have elevated risk for cardiovascular problems, autoimmune disorders and some infectious diseases.

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US Food and Drug Administration