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
