Fluorescence immunochromatographic assay 25-hydroxy Vitamin D diagnostic

[Intended use]

25OH Vitamin D total Kit (Immunofluorescence) is mainly for the in vitro quantitative measurement of 25-hydroxyvitamin D2 and D3 (25OH-D2 and 25OH-D3) in serum and plasma. It is useful as an aid in management and monitoring of regulating the concentration of calcium and phosphate in the bloodstream and promoting the healthy growth and remodeling of bone. 25OH Vitamin D might also be active in other tissues responsible for calcium transport (placenta, kidney, mammary gland …) and endocrine gland (parathyroid glands, beta cells…).

Vitamin D is the generic term used to designate Vitamin D2 and Vitamin D3. Humans naturally produce Vitamin D3 when the skin is exposed to ultraviolet sun rays. In the liver mainly, Vitamin D3 is metabolised into 25-Hydroxyvitamin D3 (25OH-D3) which is the main form of Vitamin D circulating in the body. Vitamin D3 and Vitamin D2 are also available by ingestion through food or dietary supplementation.

Vitamin D deficiency is an important risk factor for rickets, osteomalacia, senile osteoporosis, cancer and pregnancy outcomes.Vitamin D intoxication has been shown to cause kidney and tissue damages.

[Test principle]

The test uses a competitive immunodetection method. Add the sample to the sample well of the cartridge. Through chromatography, the sample reacts with the fluorescent latex particles coated with monoclonal antibody on the conjugate pad. The complex spreads ahead along the nitrocellulose membrane captured by the covalent couple of 25OH-D3 and bovine serum albumin (BSA) on the test line. The more target material the sample contains, the less complexes the test line accumulates. The intensity of fluorescent antibody signal reflects the amount of captured 25OH-D2/D3. The immunofluorescence quantitative analyzer produced by our company can detect the concentration of 25OH-D2/D3 in the sample.

[Package]

25 Tests /Box

[Materials provided]

Contents

25   Cartridges

1    Calibration Card

25   Diluent

1    Releasing Buffer Vial

[Storage and stability]

²  Sealed: The kit must be stored at 10-30℃, valid for 18 months.

²  Opened: The cartridge must be used within 1 hour once its foil pouch is opened. Opened diluent and Sample Diluent are stable for 12 months at 2-8 °C if kept capped in original container and free from contaminations.

[Procedure]

1. Transfer 90μL of releasing buffer using a transfer pipette to a diluent tube.

2. Add 10 μL sample (Human serum/plasma) using a transfer pipette to the diluent tube containing releasing buffer and mix well by pipetting 10 times.

3. Leave the tube in the tube block for 5 min.

4. Remove the cartridge (after reaching room temperature), draw in 90μL of the incubated mixture to the well and incubate it for 10 minutes in the reagent strip incubator.

5. After incubation insert the cartridge into the immunofluorescence quantitative analyzer (NRM-FI-1000) using the cartridge arrows as a guide, and click start, then the instrument will scan the cartridge automatically.

[Expected values/Reference range]