βhCG
Beta-Human Chorionic Gonadotropin
REF: DS177712

Please note
The measured hCG value of a patient’s sample can vary depending on the testing procedure used. The laboratory finding must therefore always contain a statement on the hCG assay method used. hCG values determined on patient
samples by different testing procedures cannot be directly compared with one another and could be the cause of erroneous medical interpretations.
If there is a change in the hCG assay procedure used while monitoring therapy, then the hCG values obtained upon changing over to the new procedure must be confirmed by parallel measurements with both methods.

Intended use
Immunoassay for the in vitro quantitative determination of the sum of human chorionic gonadotropin (hCG) plus the hCG β‐subunit in human serum.

Summary
Similarly to LH (Luteinizing hormone), FSH (Follicle‐stimulating hormone) and TSH (Thyroid‐stimulating hormone), human chorionic gonadotropin (hCG) is a member of the glycoprotein family and consists of 2 subunits (α‐1 and β‐chains) which are associated to form the intact hormone.1 The α‐chains in all four of these glycoprotein hormones are virtually identical, whereas the β‐chains have greatly differing structures andare responsible for the respective specific hormonal functions.2 hCG is produced in the placenta during pregnancy. In non‐pregnant women, it can also be produced by tumors of the trophoblast, germ cell tumors with trophoblastic components and some non‐trophoblastic tumors.3 hCG assays detecting the intact hCG plus the free β‐subunit are well established markers as an aid in the management of patients with trophoblastic tumors4 and
together with AFP in patients with testicular and other germ cell tumors.5

Reagents
Materials provided
• Coated Microplate, 8 x 12 strips, 96 wells, pre-coated with mouse monoclonal hCG-specific antibodies.
• Calibrators, 6 vials, 1 ml each, ready to use; Concentrations: 0(A), 5(B), 20(C), 50(D), 100(E) and 200(F) mIU/mL.
• Enzyme Conjugate, 1 vial, 11 mL of HRP (horseradish peroxidase) labeled mouse monoclonal hCG-specific antibodies in Tris-NaCl buffer containing BSA (bovine serum albumin). Contains 0.1% ProClin300 preservative.
• Sample Dilute Concentrate, 1 vial, 11 mL of serum diluent concentrate containing buffer containing 0.1% ProClin300 preservative
• Substrate, 1 vial, 11ml, ready to use, (tetramethylbenzidine) TMB.
• Stop Solution, 1 vial, 6.0 ml of 1 mol/l sulfuric acid.
• Wash Solution Concentrate, 1 vial, 25 mL (40X concentrated), PBS-Tween wash solution.
• IFU, 1 copy.
• Plate Lid: 1 piece.
Materials required (but not provided)
• Microplate reader with 450nm and 620nm wavelength absorbent capability.
• Microplate washer.
• Incubator.
• Plate shaker.
• Micropipettes and multichannel micropipettes delivering 50μl with a precision of better than 1.5%.
• Absorbent paper.
• Distilled water

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