- Type:Medical Incubator
- Name:Total Thyroxine Test T4 Rapid Test Kits CE Approved
- Power Source:Manual
- Warranty:1 Year
- After-sale Service:Onsite Training
- Material:Plastic
- Shelf Life:2 years
- Quality Certification:ce
- Instrument classification:Class III
- Safety standard:EN 149 -2001+A1-2009
- Place of Origin:CN;FUJ
- Model Number:T4
- Brand Name:WIZ
Total Thyroxine Test T4 Rapid Test Kits CE Approved
Descriptions
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.
INTENDED USE
Diagnostic Kit for Total Thyroxine (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Total Thyroxine (TT4) in human serum or plasma, which is mainly used to evaluate thyroid function. It is an auxiliary diagnosis reagent. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.
SUMMARY
Thyroxine(T4) is secreted by the thyroid gland and its molecular weight is 777D. The total T4(Total T4, TT4) in the serum is 50 times that of the serum T3. Among them, 99.9 % of TT4 binds to serum Thyroxine Binding Proteins(TBP), and free T4(Free T4, FT4) is less than 0.05 %. T4 and T3 participate in regulating the body's metabolic function. TT4 measurements are used to evaluate thyroid functional status and diagnosis of diseases. Clinically, TT4 is a reliable indicator for the diagnosis and efficacy observation of hyperthyroidism and hypothyroidism.
PRINCIPLE OF THE PROCEDURE
The membrane of the test device is coated with the conjugate of BSA and T4 on the test region and goat anti-rabbit IgG antibody on the control region. Marker pad is coated by fluorescence mark anti T4 antibody and rabbit IgG in advance. When the testing sample, TT4 in sample combine with fluorescence marked anti T4 antibody and form the immune mixture. Under the action of the immunochromatography, the complex flow in the direction of the absorbent paper, when complex passed the test region, The free fluorescent marker will be combined with T4 on the membrane. The concentration of TT4 is a negative correlation for fluorescence signal, and the concentration of TT4 in the 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
lB 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 the 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.
ASSAY PROCEDURE
The test procedure of the instrument sees 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 20μL serum or plasma sample to A solution, and mix well.
7. Add 20μL B solution to the above mixture, and mix well.
8. Leave the mixture for 20 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).
Send Message
Related Products
