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