ISO13485 certification Vitamin D elisa test kit

タイトルまたは説明

Vitamin D elisa test kit


Intended use
The **-Hydroxy Vitamin D ELISA kit is an enzymeimmunoassay intended for the
quantitative determination of total **-hydroxy vitamin D in human serum, plasma,
tissue homogenates and other biological fluids. Results are to be used in
conjunction with other clinical and laboratory data to assist the clinician in the
assessment of vitamin D sufficiency.
Summary
Vitamin D is a fat-soluble steroid hormone precursor that is mainly produced in the
skin by exposure to sunlight. Vitamin D is biologically inert and must undergo
hydroxylation steps to become active.(1)
Our body can only synthesize vitamin D3. Vitamin D2 is taken up with fortified
food or given by supplements. Physiologically, vitamin D3 and D2 are bound to
the vitamin D-binding protein (VDBP) in plasma and transported to the liver to
become **-hydroxyvitamin D (vitamin D (**-OH)).
As vitamin D (**-OH) represents the major storage form, its blood concentration is
used to assess the overall vitamin D status. More than *5 % of vitamin D (**-OH),
measurable in serum, is vitamin D3 (**-OH) whereas vitamin D2 (**-OH) reaches
measurable levels only in patients taking vitamin D2 supplements.(1,2,3)
Vitamin D is essential for bone health. In children, severe deficiency leads to
rickets. In elderly, the risk of falling has been attributed to vitamin D deficiency due
to muscle weakness. Moreover, low vitamin D (**-OH) concentrations are
associated with lower bone mineral density. Insufficiency has also been linked to
diabetes, cancer, cardiovascular disease, and autoimmune diseases.(1) The **-
OH Vitamin D is intended for the quantitative determination of vitamin D (**-OH)
in human serum, plasma, tissue homogenates and other biological fluids, as an
aid in the assessment of vitamin D sufficiency.
Test principle
Competition principle. Total duration of assay: *5 minutes.
• Sample, **-Hydroxyvitamin D derivant coated microwells and enzyme labeled
Anti- **-Hydroxyvitamin D are combined.
• During the incubation, **-Hydroxyvitamin D derivant coated on microwells and
**-Hydroxyvitamin D present in the sample compete for binding to the enzyme
labeled antibodies.
• After washing, a complex is generated between the solid phase and
enzymelinked antibodies by immunological reactions.
• Substrate solution is then added and catalyzed by this complex, resulting in a
chromogenic reaction. The resulting chromogenic reaction is measured as
absorbance.
• The color intensity is inversely proportional to the amount of **-Hydroxyvitamin
D in the sample.