For in vitro diagnostic use only
Please read this package insert carefully prior to use and strictly follow the instructions. Reliability of assay results cannot be guaranteed if there are any deviations from the instructions in this package insert.
Diagnostic Kit for 25-hydroxy Vitamin D (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of 25-hydroxy Vitamin D (25-(OH)VD) in human serum or plasma, which is mainly used to evaluate the levels of vitamin D.It is an auxiliary diagnosis reagent.All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.
Vitamin D is a vitamin and is also a steroid hormone, mainly including VD2 and VD3, whose struction is very similar. 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 OF THE PROCEDURE
The membrane of the test device is coated with the conjugate of BSA and 25-(OH)VD on the test region and goat anti rabbit IgG antibody on the control region. Marker pad are coated by fluorescence mark 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, The free fluorescent marker will be combined with 25-(OH)VD on the membrane.The concentration of 25-(OH)VD is negative correlation for fluorescence signal, and the concentration of 25-(OH)VD in sample can be detected by fluorescence immunoassay assay.
REAGENTS AND MATERIALS SUPPLIED
25T package components:
l Test card individually foil pouched with a desiccant 25T
l A solution 25T
l B solution 1
l Package insert 1
MATERIALS REQUIRED BUT NOT PROVIDED
Sample collection container,timer
SAMPLE COLLECTION AND STORAGE
1. The samples tested can be serum, heparin anticoagulant plasma or EDTA anticoagulant plasma.
2. According to standard techniques collect sample. Serum or plasma sample can be kept refrigerated at 2-8℃ for 7days and cryopreservation below -15°C for 6 months.
3. All sample avoid freeze-thaw cycles.
The test procedure of the instrument see the immunoanalyzer manual. The reagent test procedure is as follows
1. Lay aside all reagents and samples to room temperature.
2. Open the Portable Immune Analyzer(WIZ-A101), enter the account password login according to the operation method of the instrument, and enter the detection interface.
3. Scan the dentification code to confirm the test item.
4. Take out the test card from the foil bag.
5. Insert the test card into the card slot, scan the QR code, and determine the test item.
6. Add 30μL serum or plasma sample to A solution, and mix well.
7. Add 50μL B solution to the above mixture, and mix well.
8. Leave the mixture for 15 minutes.
9. Add 80μL mixture to sample well of the card.
10. Click the "standard test" button,after 10 minutes, the instrument will automatically detect the test card, it can read the results from the display screen of the instrument, and record/print the test results.
11. Refer to the instruction of Portable Immune Analyzer(WIZ-A101).