E2 Rapid Test Kits Estradiol Test Device Cassette for Female/Male

 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 Estradiol (fluorescence immunochromatographic assay) is a fluorescence immunochromatographic assay for the quantitative detection of Estradiol (E2) in human serum or plasma, which is mainly used to evaluate the levels of Estradiol.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

Estradiol(E2) is the most important and most active hormone in estrogen.Its molecular weight is 272.3 D.In general,for non-pregnant women,E2 is mainly secreted by sheath and granular cells and luteal cells during follicular development.During pregnancy,E2 is mainly secreted by the placenta, while men are mainly produced by the testicles.After E2 enters the blood,1% to 3% do not bind to proteins, 40% bind to sex hormone binding globulin(SHBG),and others bind to albumin,metabolize from the liver into water-soluble sulfates or gluconaldehyde esters,and excreted from the urine.E2 is an important hormone indicator for evaluating ovarian function.

PRINCIPLE OF THE PROCEDURE

The membrane of the test device is coated with the conjugate of BSA and Estradiol on the test region and goat anti rabbit IgG antibody on the control region. Marker pad are coated by fluorescence mark anti E2 antibody and rabbit IgG in advance. When testing sample,E2 in sample combine with fluorescence marked anti E2 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 Estradiol on the membrane.The concentration of Estradiol is negative correlation for fluorescence signal, and the concentration of Estradiol in 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

l B solution1

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 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 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. 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).