T3 Rapid Test Kit for Total Triiodothyronine fluorescence immunochromatographic assay

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 Triiodothyronine (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Total Triiodothyronine (TT3) 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

Triiodothyronine(T3) molecular weight 651D. It is the main active form of thyroid hormone. Total T3(Total T3, TT3) in the serum is divided into binding and free types. 99.5 % of TT3 binds to serum Thyroxine-Binding Proteins(TBP), and free T3(Free T3) accounts for 0.2 to 0.4 %. T4 and T3 participate in maintaining and regulating the body's metabolic function.TT3 measurements are used to evaluate thyroid functional status and diagnosis of diseases. Clinical TT3 is a reliable indicator for the diagnosis and efficacy observation of hyperthyroidism and hypothyroidism. The determination of T3 is more significant for the diagnosis of hyperthyroidism than T4.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with the conjugate of BSA and T3 on the test region and goat anti-rabbit IgG antibody on the control region. Marker pad is coated by fluorescence mark anti-T3 antibody and rabbit IgG in advance. When a testing sample, TT3 in sample combine with fluorescence marked anti-T3 antibody and form an 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 T3 on the membrane. The concentration of TT3 is a negative correlation for fluorescence signal, and the concentration of TT3 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 desiccant25T

l A solution25T

lBsolution1

l Package insert1

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 identification 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. Add20μLB 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).