β-human Chorionic Gonadotropin(β-hCG)

INTENDED USE

Detection Kit for β-human Chorionic Gonadotropin (β-hCG)(ELISA).It is used in quantitative tests for β-human Chorionic Gonadotropin in human serum or urine..

SUMMARY AND CLINICAL SIGNIFICANCE

Human chorionic gonadotropin (HCG) is a glycoprotein composed of 237 amino acids with a molecular mass of 25.7 kDa. It is heterodimeric, with an α subunit identical to that of luteinizing hormone (LH), follicle-stimulating hormone (FSH), thyroid-stimulating hormone (TSH), and β (beta) subunit that is unique to hCG. The β-subunit of hCG gonadotropin contains 145 amino acids.

β-HCG-positive indicates an implanted blastocyst and mammalian embryogenesis. Gestational trophoblastic disease like hydatidiform moles (molar pregnancy) or choriocarcinoma may produce high levels of β-hCG despite the absence of an embryo. It also can be used as a tumor marker, as its β subunit is secreted by some cancers including seminoma, choriocarcinoma, germ cell tumors, hydatidiform mole formation, teratoma with elements of choriocarcinoma, and islet cell tumor.

Product Detail

PRINCIPLE

β-HCG uses a “sandwich principle”, Enzyme-linked immunological sorbent assay. To measure β-HCG levels in serum or urine, plastic wells coated with a monoclonal antibody of β-HCG are supplied in the kit. The patient’s specimen is added and, during incubation, β-HCG, if present, is fixed to the solid phase antibody, when another mono-antibody labelled with HRP is added, creating a HRP-antibody—β-HCG—antibody “sandwich”. After TMB substrate added, the result is obtained by EIA plate reader.

MAIN COMPONENTS

• Coated Microplate: 1 plate (8×12 wells), Ready to use. Coated with anti-β-HCG antibody and sealed in an aluminum bag. Remove the strips in the resealable bag with a desiccant to protect from moisture after opened. Store at 2~8℃ until expiration date.

• HRP Conjugate: 1 vial of 6ml, Ready to use. Store at 2~8℃ until expiration date.
• Calibrator: 6 vials of 0.5ml, Ready to use. Labeled with S₀ to S₅ and the concentration of HCG is 0, 8, 16, 40, 100, 240 IU/L. Store at 2~8℃ until expiration date.
• Control: 2 vials of 0.5ml, Ready to use. The concentration of low value is 19.6~36.4IU/L. The concentration of high value is 133~247IU/L. Store at 2~8℃ until expiration date.
• Urine sample dilution: 1 vial of 15ml, Concentrate 10-fold, diluting with deionized water before the assay. Store at 2~8℃ until expiration date.
• Chromogen A: 1 vial of 7ml, Ready to use. Store at 2~8℃ until expiration date.
• Chromogen B: 1 vial of 7ml, Ready to use. Store at 2~8℃ until expiration date.
• Stop Solution: 1 vial of 7ml, Ready to use. Store at 2~8℃ until expiration date.
• Wash buffer: 1 vial of 15ml, Concentrate 20-fold, diluting with deionized water before the assay. Store at 2~8℃ until expiration date.
• Plate sealer: 2 pieces.
• Plastic resealable bag: 1 set.
• Instruction manual: 1 copy..

RELATED TIPS

ATTENTIONS

1. Do not exchange reagents from different lots or use reagents from other commercially available kits. The components of the kit are precisely matched for optimal performance of the tests.

2. Specimens with Hyperlipidemia and icterus show no effects on the detection results. But specimen with severe hemolysis will affect the color of the result, other test methods are suggested to use.

3. Allow the reagents and specimens to reach room temperature before use. Shake reagent gently before use.

4. Concentrated washing liquid will produce crystal at room temperature, should be diluted completely before use.

5. Never reuse microplate sealing membrane.

6. Samples containing anti-sperm antibody, anti-endometrial antibody will not affect the results.

7. Each component of the kit was inactivated, however, it should be regarded as potentially infectious.

PRECAUTION FOR USERS

1. Handling should preclude any pipetting by mouth. Use only pipettes with disposable tips for each specimen.

2.Do not mix materials from different master lots. Do not use kit components beyond the expiration date.

3.All materials should be brought to room temperature before use.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world