Accurate monitoring of total 25(OH)D levels is important as vitamin D deficiency is linked to many conditions such as osteoporosis, rickets, cardiovascular disease, and cancer. The innovative 25-hydroxy vitamin D assay by Diazyme Laboratories is a homogenous enzyme-immunoassay intended for the quantitative determination of 25-(OH) D levels in serum or plasma, on automated chemistry analyzers for the assessment of Vitamin D sufficiency. It detects total Vitamin D (D2 + D3), thus providing accurate results for total Vitamin D concentrations. The results correlate well with LC-MS/MS and DiaSorin Liaison methods.
This FDA-approved assay utilizes Diazyme's FemtoQuant TM technology to ensure high sensitivity and specificity without phase separation steps. With this assay, many clinical laboratories can run the total Vitamin D test in-house at a cost-effective price, without the need for special instrumentation. This is the first fully automated Vitamin D assay for clinical chemistry analyzers.
Assay Features
- Liquid stable format
- Kit (80 tests)
- 15-19 minutes to first result
- No off-line sample pretreatment needed
- Multiple instrument options
- Directly traceable to NIST SRM-972 standards
The assay kit consists of five serum calibrators (containing assigned amounts of 25(OH)D, a sample diluent and three reagents. All reagents are liquid stable, and come with on-board stability of more than four weeks. Each kit is supplied with a liquid calibrator set for added convenience and the controls are available separately. Once the application parameters are programmed into a general chemistry analyzer channel, the assay can be run by a technician with the most basic clinical chemistry skills. No special training is required. The assay requires only 20 uL of sample and returns patient results within 19 minutes.