Beta subunit of human chorionic gonadotropin (β-hCG) Assay Kit (Fluorescence Immunochromatographic Assay)

Beta subunit of human chorionic gonadotropin (β-hCG) Assay Kit (Fluorescence Immunochromatographic Assay)

[Product Name]

General name: Beta subunit of human chorionic gonadotropin (β-hCG) Assay Kit (Fluorescence Immunochromatographic Assay)

【Packing Specification】

25 persons/box

【Intended Use】

It is suitable for quantitative determination of β-human chorionic gonadotropin (β-hCG) in human serum or plasma in vitro.

Clinically, it is used for the auxiliary diagnosis of ectopic pregnancy and early pregnancy, but not for the auxiliary diagnosis of tumor.

【Test Principle】

Based on the principle of fluorescence immunochromatography, the kit applies the double antibody sandwich method to quantitatively determine the concentration of β-hCG in human serum or plasma. The sample to be tested is added into the sample diluent and mixed evenly, and then the mixed solution is added into the sample adding hole of the detection card. β-hCG in the sample to be tested binds to fluorescent labeled anti-β-hCG antibody on the binding pad to form β-hCG-antibody complex. As the β-hCG-antibody complex diffuses along the nitrocellulose membrane by chromatography, the β-hCG-antibody complex begins to bind with the antibody coated in the detection line (T). The higher the β-hCG concentration, the more complexes gather on the detection line, and the deeper the fluorescence band at a specific wavelength. The signal intensity of fluorescent antibody is positively correlated with the concentration of substances to be detected in samples. The fluorescent labeled goat anti-rabbit IgG antibody diffuses to the control line (C) region and is captured by the rat anti-rabbit IgG antibody to form a fluorescent ribbon at a specific wavelength. When the reaction is finished, the optical density of quality control line and detection line can be analyzed by matching instruments, and the concentration of the substance to be measured can be calculated in mIU/mL.

【Main Component】

centrifugeStorage Conditions and Validity】

This kit is kept at 2~30℃, under sealed state of aluminum foil bag. Its shelf life is 18 months. After the unsealing of aluminum foil bag, this kit should be used within one hour. Production date and expiry date are shown in the package or label.

【Applicable Instrument】

GS-F1000 dry fluorescence immunoanalyzer produced by Shenzhen Lvshiyuan Biotechnology Co., Ltd. or AFS-1000 dry fluorescence immunoanalyzer produced by Guangzhou Labsim Biotechnology Co., Ltd..

[Sample Requirements]

1. Serum or plasma.
2. Plasma samples are recommended to be anticoagulated with heparin sodium, citrate and EDTA.
3. The specimen of serum or plasma should be stored under room temperature (18~26℃) for not more than one day, at 2~8℃ for not more than three days, and at -20℃ for not more than one month.
4. Before the test, the sample must be restored to room temperature. Only after the complete thawing, temperature restoration and uniform mixing, the sample of frozen storage can be used.

[Test Method]

1. Only after the restoration to room temperature (20~25℃), the kit of low-temperature storage can be used.
2. Turn on the instrument according to the instrument manual.
3. Check whether the ID chip is consistent with the batch number of the kit. Do not touch the insertion end of the ID chip when inserting the ID chip.
4. External package is torn off. Test card is taken out, and put flatly onto the surface of horizontal operating table.
5. Absorb 20 of samples after mixing, and add them into the sample diluent tube and fully mixed;
6. Absorb 70μL of diluted sample and drop it into the sample hole of the test card. Bubbles should be avoided during sampling.
7. At room temperature, keep it still for 15 minutes, put it into the card slot and read the card according to the requirements of the instrument manual. The test results will be automatically displayed on the instrument screen, and the results can be saved and printed.

[Positive judgment value or reference interval]

The reference range of β-hCG for this kit is 0~20 mIU/mL. Serum samples from 200 healthy women (non-pregnant women) aged between 18 and 65 years are selected for the experiment, and the data are statistically analyzed by nonparametric 95% confidence interval. Because of the differences in geography, race, sex and age, it is suggested that each laboratory should establish its own reference interval.

[Interpretation of Test Results]

Applicable instruments will automatically carry out detection, and the detection results will be displayed on the screen in mIU/mL.

[Limitations of Test Method]

1. This kit is used only for auxiliary diagnosis. Final clinical conclusion should be made through doctors by overall considering other diagnostic/examination results and test data.
2. Possible reasons for false positive result: Similar antibody or antigen of high concentration in the sample produces cross-reaction. Some small molecular substances with similar antigenic determinant to that of β-hCG antigen produce a nonspecific binding with fluorescent labeled antibody.
3. Possible reasons for false negative result: The concentration of the substance to be detected in the sample is extremely low; the concentration of test substance is extremely high in the sample to produce HOOK effect; under the extreme condition, false negative result will be displayed. Some unknown compositions shield the antigenic determinant from binding with antibody.
4. Wrong results may also be caused by other factors, including: technological factors, misoperation and other sample factors.
5. Interference test: At the test on following substances of specified concentration, interference phenomenon is not found.

6. HOOK effect: When the concentration of β-hCG is up to 250000mIU/mL, there is no HOOK effect.

[Product Performance Indicators]

1. Accuracy: The relative deviation of national standard product or accuracy reference is within ±15.0%.
2. LOD should not be more than 5mIU/mL.
3. Inter-batch precision: The coefficient of variation (CV) is ≤15% when the reference is determined by several kits of same batches.
4. Batch-to-batch precision: The coefficient of variation (CV) is ≤15% when the reference is determined by several kits of different batches.
5. The linearity of dose-response curve: In the range of 5~50000mIU/mL, the linear correlation coefficient of dose-response curve is R > 0.99.
6. Specificity:

Test the LH sample with a test concentration of 500mIU/mL, and the results of β-hCG is not higher than 5mIU/mL.

Test the FSH sample with a test concentration of 1000mIU/mL, and the results of β-hCG is not higher than 5mIU/mL;

Test the TSH sample with a test concentration of 1000mIU/L, and the results of β-hCG is not higher than 5mIU/mL.

[Precautions]

1. This kit is only used for in vitro diagnosis; single-use
2. This kit should be treated as containing infective materials.
3. All samples, reagents and potential contaminants should be disinfected and treated according to the relevant local regulations.
4. Please read the Manual of this reagent and instrument carefully before performing all operations.
5. Reagents with different batch numbers cannot be mixed with each component; and each batch of reagents has corresponding parameters, which must be updated. Otherwise, the new batch of product reagents will not be recognized by the instrument.

[Interpretation of Signs]

	Single-use		Storage temperature
	In vitro diagnostic instruments		Batch number
	Person/box		Refer to the specification

[References]

1. Chard T. (1992). Hum. Reprod. 7 (5): 701-710.
2. Hsu et al (1998). J. Assist. Reprod. Genet. 15 (8): 496-503.
3. Shi Yifu, Treatment of Trophoblastic Tumors (J) Chinese Journal of Practical Gynecology and Obstetrics, 2002, 18 (8): 4621.

[Basic Information]

Enterprise name: Shenzhen Lvshiyuan Biotechnology Co., Ltd.

Registered address: 101.201.301, D Building, National Biological Industrial Park of Marinelife, No.2 Binhai Road, Dapeng, Shenzhen, China

Production address: 101.201.301, D Building, National Biological Industrial Park of Marinelife, No.2 Binhai Road, Dapeng, Shenzhen, China

After-sales Service Unit: Shenzhen Lvshiyuan Biotechnology Co., Ltd.

Production License No.: YSYJXSCX No. 20142513

Postcode: 518120

Tel.: 0755-28438788/28438000

Fax: 0755-28938800

Website: www.lsybt.com