Diazyme Laboratories recently obtained 510(K) clearance from the U.S. Food and Drug Administration (FDA) to market its Vitamin D assay for clinical chemistry analyzers. Diazyme’s Vitamin D assay is the first and the only fully automated Vitamin D test that is specifically designed for use on general clinical chemistry analyzers.
There has been a rapid increase in clinical demands for testing of this important biomarker. Many organs need vitamin D – the brain, breast, prostate, intestine and immune cells. A mild lack of vitamin D may simply cause tiredness and general aches. However, a severe deficiency of vitamin D can result in serious problems such as rickets in children and osteomalacia in adults. Physicians prescribing vitamin D therapy also have to be careful as very high doses can raise calcium levels in the blood. Elevated levels of calcium in the blood can cause hypercalcemia. All this underlines the importance of vitamin D assays.
Diazyme’s innovative Vitamin D assay utilizes femtoquant™ technology, a sensitive homogenous enzyme-immunoassay platform, and measures total 25-hydroxy Vitamin D (sum of 25-(OH)D3 + 25-(OH)D2 ) levels. This Vitamin D assay offers many benefits for clinical labs of all sizes:
- Can run Vitamin D test in house without the need for expensive specialized instruments
- Provides precise test results
- Is user-friendly
- Has excellent correlation to the existing commercial methods
- Is cost-effective
This high-throughput liquid stable assay is designed to help clinical laboratories improve their workflow and reduce their turnaround time for test results.
New Diazyme products that can be purchased online from leading lab equipment stores include the 25-OH Vitamin D Assay for clinical chemistry analyzers and the 25-OH Vitamin D Two (2) Level Control Set, 2 x 1 mL vial.
Diazyme’s 25-OH Vitamin D Assay for clinical chemistry analyzers is a liquid-stable, three-reagent assay for in-vitro diagnostic use. It is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) in human serum and plasma, requires only 20 uL of sample, and returns patient results within a short span of 19 minutes. The 25-OH Vitamin D Two (2) Level Control Set is intended for use as a quality control for Diazyme 25-OH Vitamin D Assay Kit.