Fast and Fully Automated Determination of Vitamin D Levels with Alegria®
11 Jul 2013

Beyond the existing range of tests for autoimmune and infectious disease diagnostics ORGENTEC Diagnostika opens a new door for additional Alegria® applications. The innovative 25-OH Vitamin D3/D2 assay allows for rapid “walk away” analysis of a patient’s vitamin D status – for single samples and up to 30 tests in only 120 minutes.

The 25-OH Vitamin D3/D2 test was specifically designed for Alegria®, ORGENTEC’s established random access analyzer. The new test detects both forms of vitamin D, physiological 25-(OH)-vitamin D3 and synthetic 25-(OH)-vitamin D2 with the same high sensitivity. The 25-OH Vitamin D3/D2 test for Alegria® shows excellent correlation with HPLC.

Every Alegria® Test Strip is equipped with all of the reagents needed to test a patient sample. No separate sample preparation steps are required before testing: a special sample buffer releases 25-(OH)-vitamin D3/D2 from the vitamin D binding protein complex in the serum. The test kit’s individual barcode contains all of the information required for the analysis and evaluation of the ELISA. The standardized calibration is based on the internationally recognised NIST reference material SRM 2972.

Vitamin D is important for the maintenance of bone health and has a potential role in the prevention of nonskeletal disorders such as autoimmune disease, cancer, mental health problems and cardiovascular disease.

The main part of vitamin D is produced in the skin upon exposure to sunlight, while intake of vitamin D from dietary sources is limited. In northern latitudes, only the summer sun is intense enough for sufficient vitamin D synthesis. In winter, with short days and low position of the sun, there is no appreciable production of vitamin D in the skin. In developed countries, indoor lifestyle at work and during leisure contributes to lower vitamin D synthesis even in summer. In particular, pregnant and breastfeeding women, and people with darker skin share a high risk of insufficient vitamin D levels. Vitamin D deficiency is common among elderly people and may contribute to the development of osteoporosis and to falls and fractures.

The best way of estimating the vitamin D status is measurement of serum 25-(OH)-vitamin D by determination of the total concentration of vitamin D3 produced in the skin, and vitamin D2 from food supplements. Both are metabolized in exactly the same way in the liver to the corresponding 25-(OH)-derivative, which is stored as a complex bound to the vitamin D binding protein in the blood.

Based in Mainz, Germany, ORGENTEC Diagnostika is a global leader in development, production, and marketing of test systems for laboratory diagnostics. ORGENTEC Diagnostika offers numerous highly specific ELISA tests, immunoblots and kits for immunofluorescence assays. Alegria®, the innovative random access analyzer allows for fully automated autoimmune diagnostics and infectious disease serology. The point of care test rheumachec® has been the first rapid test for diagnosing rheumatoid arthritis.

With distribution channels in Germany, Austria, Switzerland, Hungary, and France, as well as an established global distribution network, ORGENTEC’s products and laboratory tests are benefitting patients in over 100 countries around the world.

For more information on Vitamin D see the special feature on ORGENTEC's homepage: http://www.orgentec.com/index.php/en/about-us/lounge/special-feature

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Sonia Nicholas
Clinical Diagnostics Editor