Vitamin D FIA Rapid Test

【INTENDED USE】

  The VD Semi-Quantitative Rapid test Cassette (FIA) is a rapid chromatographic immunoassay for the semi-quantitative detection of 25-hydroxy Vitamin D in plasma and serum which is mainly used to evaluate the levels of vitamin D.

【SUMMARY】

  Vitamin D is a vitamin and is also a steroid hormone, the two major physiologically relevant forms of which are vitamin D2(ergocalciferol) and vitamin D3 (cholecalciferol). Vitamin D3 and D2 are converted to 25 hydroxyl vitamin D(including 25-dihydroxyl vitamin D3 and D2). 25-(OH) VD in the human body, stable struction, high concentration. 25-(OH) VD reflects the total amount of vitamin D , and the conversion ability of vitamin D, so 25-(OH)VD is considered to be the best indicator for evaluating the level of vitamin D. The Diagnostic Kit is based on immunochromatography and can give a result within 15 minutes.

【PRINCIPLE】

  The membrane of the test device is coated with the conjugate of anti-25-(OH)VD antibody on the test region and goat anti rabbit IgG antibody on the control region. Marker pad are coated by fluorescence marked anti 25-(OH)VD antibody and rabbit IgG in advance. When testing sample, 25-(OH)VD in sample combine with fluorescence marked anti 25-(OH)VD antibody, and form immune mixture. Under the action of the immunochromatography, the complex flow in the direction of absorbent paper, when complex passed the test region, complex fluorescent marker will be combined with anti-25-(OH)VD antibody on the membrane. If the concentration of 25-(OH)VD in specimen is higher than 30ng/mL only T1 line can be observed with the reader. And if the concentration is higher than 60ng/mL T2 line and T1 line can be observed together. The C line will always be observed in any concentration of the specimen. When the cassette inserted into the reader the fluorescence marked line will be seen as red line.

【DIRECTIONS FOR USE】

  Read the instruction manual and the fluorescence immunoassay analyzer operation manual thoroughly before performing the test.

1.   1、Before the experiment, the refrigerated reagents and test samples should be balanced to room temperature; the memory is inserted into the instrument,the instrument automatically recognizes, and the batch information is confirmed to be consistent with the batch on the kit;

2.   2、Remove the test card from the original packaging reagent bag, place it on a clean platform, place it horizontally and mark it. It should be used as soon as possible within 1 hour.

3.   3、Unseal the buffer and transfer 10μL of the sample into the buffer (See illustration 1) ,insert the head of the tube and mix well (See illustration 2).

4.   4、Transfer 6 drops of the buffer (approx.90μL) into the sample well (See illustration 3).

5.   5、Wait and read the result with reader (See illustration 4) at 10 minutes. Do not interpret the result after 15 minutes.

【INTERPRETATION OF RESULTS】

<30ng/mL：Only C line appear, T1 and T2 line cannot be observed.

30ng/mL~60ng/mL：Both C line and T1 line appear, T2 line cannot be observed.

≥60ng/mL：All the three lines appear.

Invalid：Control line fails to appear. Insufficient sample volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test Device. If the problem persists, discontinue using the test Device immediately and contact your suppliers