Elecsys® FSH Electrochemiluminescence immunoassay (ECLIA) for the in vitro quantitative determination of follicle-stimulating hormone in human serum and plasma Indication Together with luteinizing hormone (LH), follicle-stimulating hormone (FSH) regulates and stimulates the growth and function of the ovaries and testes synergistically.1 FSH is part of the gonadotropin family of hormones that act within the hypothalamuspituitary-ovary regulating circuit to control the menstrual cycle in women and spermatogonium development in men.2,3 Measurement of FSH is used clinically to investigate dysfunctions within the hypothalamus-pituitary-gonad system. In conjunction with LH, FSH is also used to investigate congenital diseases with chromosome aberrations, polycystic ovaries, amenorrhea, and menopausal syndrome.1,3–5 Test principle: sandwich immunoassay FSH in the sample Streptavidin-coated microparticle Ru Biotinylated monoclonal antibody against human FSH Ruthenylated monoclonal antibody against human FSH 1st Incubation (9 minutes): 40 μL of the sample is incubated with both a biotinylated, monoclonal FSH-specific antibody and a ruthenylated, monoclonal FSH-specific antibody to form a sandwich complex. 9 min 9 min 9 Ru min Measurement Ru 2nd Incubation (9 minutes): Streptavidin-coated microparticles are added to the reaction mixture and the complex binds to the solid phase via biotinstreptavidin interactions. Measurement: The reaction mixture is transferred to a measuring cell and the microparticles are magnetically captured onto the surface of an electrode; unbound sample is washed away before a chemiluminescent reaction is induced by applying a voltage to the electrode. Chemiluminescence is measured by a photomultiplier and the concentration of FSH within the sample is calculated using a calibration curve. Elecsys® FSH test characteristics Testing time Test principle Calibration Sample material 18 minutes Sandwich immunoassay 2 point Serum, Li-, Na-, NH4+-heparin, K3-EDTA, sodium citrate (values are lower by -20 % compared to serum), and sodium fluoride/potassium oxalate (lower by approx. -14 % compared to serum) plasma Sample volume Lower detection limit Measuring range Traceability 40 μL <0.100 mIU/mL 0.100 – 200 mIU/mL Standardized against the Enzymun-Test FSH method, which was in turn standardized against the 2nd IRP WHO reference standard 78/549 Intermediate precision (CLSI) Elecsys® 2010 analyzer and cobas e 411 analyzer: 2.9 – 5.3 % (1.2 – 103 mIU/mL) Modular Analytics E170, cobas e 601 module, cobas e 602 module: 3.6 – 4.5 % (5.33 – 229 mIU/mL) Expected values N Median, mIU/mL 5th – 95th percentile, mIU/mL Men Women Follicular phase Ovulation phase Luteal phase Postmenopausal 319 4.6 1.5 – 12.4 376 56 349 181 6.9 12.3 3.6 67.0 3.5 – 12.5 4.7 – 21.5 1.7 – 7.7 25.8 – 134.8 100 tests 4 x 1 mL 2 x 3 mL each 11775863 122 03032680 122 11731416 190 Order information Elecsys® FSH FSH CalSet II PreciControl Universal 1 and 2 References 1 Johnson, M.R., Carter, G., Grint, C., Lightman, S.L. (1983). Relationship between ovarian steroids, gonadotrophins and relaxin during the menstrual cycle. Acta Endocrinol 129, 121 – 125. 2 Beastall, G.H., Ferguson, K.M., O’Reilly, D.S.J., Seth, J., Sheridan, B. (1987). Assays for follicle stimulating hormone and luteinizing hormone: guidelines for the provision of a clinical biochemistry service. Ann Clin Biochem 24, 246 – 262. 3 Broekmans, F.J., Soules, M.R., Fauser, B.C. (2009). Ovarian aging: mechanisms and clinical consequences. Endocr Rev 30, 465 – 493. 4 Ciccone, N.A., Kaiser, U.B. (2009). The biology of gonadotroph regulation. Curr Opin Endocrinol Diabetes Obes 16, 321 – 327. 5 Scott, M.G., Ladenson, J.H., Green, E.D., Gast, M.J. (1989). Hormonal evaluation of female infertility and reproductive disorders. Clin Chem 35, 620 – 630. COBAS, COBAS E, ELECSYS, MODULAR and LIFE NEEDS ANSWERS are trademarks of Roche. Not for distribution in the USA. ©2012 Roche Roche Diagnostics International Ltd. CH-6343 Rotkreuz Switzerland www.cobas.com
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