Total 25-Hydroxy Vitamin D Is a Homogenous Assay

The new assay introduces a number of enhancements including a wide dynamic range.

Produced by Diazyme (San Diego, CA, USA) the assay is fast and flexible with testing throughput up to five times faster than other competitive products. The test is user-friendly and can be used manually or easily adapted for use on fully automated microtiter plate readers, making it suitable for use in laboratories of all sizes and testing needs. The assay can also be adapted to automated chemistry analyzers such as Hitachi 911 after a sample pretreatment step.

There has been a recent increase in the number of physician requests for total 25-hydroxy vitamin D tests in the United States. This increase is due to the large number of recent clinical studies on Vitamin D deficiency, which is reported to be linked to various diseases including cancers, cardiovascular disease, diabetes, osteoporosis, multiple sclerosis, Alzheimer's disease, and all-cause mortality.

Testing of vitamin D levels has become crucial for the diagnosis and management of patients with vitamin D deficiency. "Diazyme's new 25-hydroxy vitamin D assay provides a convenient and cost effective test method for laboratories of virtually all sizes," said Dr. Chong Yuan, managing director of Diazyme Laboratories. "In addition to measuring true total vitamin D, the Diazyme 25-min D assay is directly traceable to the newest standard reference materials from the National Institute of Standards and Technology (NIST) for accurate and reliable results. This unique set of features makes the Diazyme 25-hydroxy vitamin D assay a valuable new technology for assessing this important analyte."

The US Food and Drug Administration (FDA; Silver Spring, MD, USA) has granted Diazyme 510(k) clearance to market its new 25-hydroxy vitamin D enzyme immunoassay.

Related Links:
Diazyme
US Food and Drug Administration
National Institute of Standards and Technology