One Step Influenza Detection Diagnostic IgG IgM Rapid Test Kit

Factory Direct One Step Influenza Detection Diagnostic Test Kit With CE ISO

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 Thyroid Stimulating Hormone (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Thyroid Stimulating Hormone (TSH) in human serum or plasma, which is mainly used in the evaluation of the pituitary-thyroid function. All positive sample must be confirmed by other methodologies. This test is intended for healthcare professional use only.

SUMMARY

The main functions of TSH: 1, promote the release of thyroid hormones, 2, promote the synthesis of T4, T3, including strengthening iodine pump activity, enhancing peroxidase activity, promoting the synthesis of thyroid globulin and tyrosine iodide.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with the anti-TSH antibody on the test region and goat anti-rabbit IgG antibody on the control region. Lable pad is coated by fluorescence-labeled anti-TSH antibody and rabbit IgG in advance. When testing a positive sample, the TSH antigen in sample combine with fluorescence-labeled anti TSH 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, it combined with anti-TSH coating antibody, forms the new complex.TSH level is positively correlated with the fluorescence signal, and the concentration of TSH in the sample can be detected by fluorescence immunoassay assay.

REAGENTS AND MATERIALS SUPPLIED

25T package components:

Test card individually foil pouched with a desiccant 25T

Sample diluents 25T

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

Please read the instrument operation manual and package insert before testing.

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 40μL serum or plasma sample to sample diluent, and mix well..

7. Add 80μL sample solution to sample well of the card.

8. Click the "standard test" button, after 15 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.

9. Refer to the instruction of Portable Immune Analyzer