Follicle Stimulating Hormone FSH Testing Kit Serum FSH Test Home Kit BIOVANTION

FSH Follicle-stimulating Hormone

REF: DS177710 96 tests

1. Intended use

Immunoassay for the in vitro quantitative determination of follicle-stimulating hormone in human serum.

2.Summary

FSH (follicle stimulating hormone), together with LH (luteinizing hormone), belongs to the gonadotropin family. FSH and LH regulate and stimulate the growth and function of the gonads (ovaries and testes) synergistically. Like LH, TSH and hCG, FSH is a glycoprotein consisting of two subunits (α- and β‐chains). Its molecular weight is approx. 32000 daltons. In women, the gonadotropins act within the hypothalamus‐pituitary‐ovary regulating circuit to control the menstrual cycle. (1, 2, 3) azoospermia. (1, 2, 3, 4, 5)

3. Test principle

Sandwich principle. Total duration of assay: 80 minutes.

• Sample, Anti-FSH coated microwells and enzyme labeled Anti-FSH are combined.

• During the incubation, FSH presents in the sample is allowed to react simultaneously with the two antibodies, resulting in the FSH molecules being sandwiched between the solid phase and enzyme-linked antibodies.

• After washing, a complex is generated between the solid phase, the FSH within the sample and enzyme-linked antibodies by immunological reactions.

• Substrate solutionis then added and catalyzed by this complex, resulting in a chromogenic reaction. The resulting chromogenic reaction is measured as absorbance.

• The absorbance is proportional to the amount of FSH in the sample.

4. Reagents

Materials provided

• Coated Microplate, 8 x 12 strips, 96 wells, pre-coated with mouse monoclonal Anti-FSH.

• 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 Anti-FSH in Tris-NaCl buffer containing BSA (bovine serum albumin). Contains 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 pap

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