Diagnostic Kit for Estradiol (fluorescence immunochromatographic assay)

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Diagnostic Kit for Estradiol(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 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.


25T package components .Test card individually foil pouched with a desiccant 25T .A solution 25T .B solution 1 .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 sample. Serum or plasma sample can be kept refrigerated at 2-8℃ for 7days and cryopreservation below -15°C for 6 months. .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. 3.Take out the test card from the foil bag. 4.Insert the test card into the card slot, scan the QR code, and determine the test item. 5.Add 30μL serum or plasma sample to A solution, and mix well. 6.Add 20μL B solution to the above mixture, and mix well. Leave the mixture for 20 minutes. Add 80μL mixture to sample well of the card. 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. Refer to the instruction of Portable Immune Analyzer(WIZ-A101).







follicular phase


ovulatory period


Luteal phase




.The above data is the reference interval established for the detection data of this kit, and it is suggested that each laboratory should establish a reference interval for the relevant clinical significance of the population in this region. .The concentration of Estradiol is higher than the reference range, and the physiological changes or stress response should be excluded.Indeed abnormal, should combine clinical symptom diagnosis. .The results of this method are only applicable to the reference range established by this method, and the results are not directly comparable with other methods. .Other factors can also cause errors in detection results, including technical reasons, operational errors and other sample factors.

STORAGE AND STABILITY 1.The kit is 18 months shelf-life from the date of manufacture. Store the unused kits at 2-30°C. DO NOT FREEZE. Do not use beyond the expiration date. 2.Do not open the sealed pouch until you are ready to perform a test, and the single-use test is suggested to be used under the required environment (temperature 2-35℃, humidity 40-90%) within 60 mins as quickly as possible. 3.Sample diluent is used immediately after being opened.

WARNINGS AND PRECAUTIONS .The kit should be sealed and protected against moisture. .All positive specimens shall be validated by other methodologies. .All specimens shall be treated as potential pollutant. .DO NOT use expired reagent. .DO NOT interchange reagents among kits with different lot no.. .DO NOT reuse test cards and any disposable accessories. .Misoperation, excessive or little sample can lead to result deviations.

LIMITATION .As with any assay employing mouse antibodies, the possibility exists for interference by human anti-mouse antibodies (HAMA) in the specimen. Specimens from patients who have received preparations of monoclonal antibodies for diagnosis or therapy may contain HAMA. Such specimens may cause false positive or false negative results. .This test result is only for clinical reference, should not serve as the only basis for clinical diagnosis and treatment, the patients clinical management should be comprehensive consideration combined with its symptoms, .medical history, other laboratory examination, treatment response, epidemiology and other information. .This reagent is only used for serum and plasma tests. It may not obtain accurate result when used for other samples such as saliva and urine and etc. PERFORMANCE CHARACTERISTICS

Linearity 30 pg/mL to 2000 pg/mL relative deviation:-15% to +15%.
Linear correlation coefficient:(r)≥0.9900
Accuracy The recovery rate shall be within 85% - 115%.
Repeatability CV≤15%
Specificity(None of the substances at the interferent tested interfered in the assay) Interferent Interferent concentration
T 500ng/mL
PROG 500ng/mL
Cor 500ng/mL
E3 100ng/mL
17β-E2 100ng/mL

REFERENCES 1.Hansen JH,et al.HAMA Interference with Murine Monoclonal Antibody-Based Immunoassays[J].J of Clin Immunoassay,1993,16:294-299. 2.Levinson SS.The Nature of Heterophilic Antibodies and the Role in Immunoassay Interference[J].J of Clin Immunoassay,1992,15:108-114.

Key to symbols used:

 t11-1 In Vitro Diagnostic Medical Device
 tt-2 Manufacturer
 tt-71 Store at 2-30℃
 tt-3 Expiration Date
 tt-4 Do Not Reuse
 tt-6 Consult Instructions For Use
Xiamen Wiz Biotech CO.,LTD Address:3-4 Floor,NO.16 Building,Bio-medical Workshop,2030 Wengjiao West Road,Haicang District,361026,Xiamen,China Tel:+86-592-6808278 Fax:+86-592-6808279

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