FSH IRMA

FSH IRMAC O A T E D T U B E• COATED TUBE IMMUNORADIOMETRIC ASSAY• SUITABLE FOR SERUM OR PLASMA SAMPLES• NO CENTRIGUGATION REQUIRED• STANDARD RANGE: 2.5 - 200 mIU/ml• SENSITIVITY OF 1.3 mIU/ml OF FSH• STANDARDIZED AGAINST WHO 1st I.S. FSH(83/575)• NO INTERFERENCE OR CROSS-REACTIONWITH LH, TSH OR HCGFor In Vitro Diagnostic UseCLINICAL SIGNIFICANCEFSH is a pituitary hormone that regulates ovulatoryfunction in women and testicular function in men.MEASUREMENTS ARE USEFUL FOR• Diagnosis of ovarian failure in women• Predicting response to superovulatory drugs used forin vitro fertilization* Investigating amenorrhea• Determining causes of hypogonadism in menPROCEDURE:1 2 3 437°CAdd 100 µl of standards,controls or sample to the coatedtubes.Add 200 µl of assay diluent toeach tube and vortex.Incubate 45 minutes at 37°C.Aspirate or decant the tubesand wash.567837°CAdd 300 µl of 125 I Anti-FSH toeach tube and vortex.Incubate 45 minutes at 37°C.Decant contents and washtwice.Count tubes in a gammacounter calibrated for 125 I andcalculate results.ICN Pharmaceuticals, Inc.3300 Hyland AvenueCosta Mesa, California 92626

FSH IRMA – COATED TUBECatalog Number: 07-246102 (100 Tubes)ASSAY:SAMPLE:STANDARDS:TEST PRINCIPLEImmunoradiometric100 µl serum or plasma0, 2.5, 5.0, 10, 25, 50, 100, 200 mIU/mlThe ImmuChem TM FSH-CT IRMA kit, employs an immunoradiometricassay technique to quantitate human follicle stimulatinghormone in either a serum or plasma sample. Inimmunoradiometric assays, two antibodies are generatedagainst different portions of the same antigen. In theImmuChem IRMA, one antibody is bound to a solid phasesupport (the tube), while the other antibody is labeled with 125 I.Thus when an antigen is present, it simultaneously binds bothantibodies in a “bridge” or “sandwich” fashion. This entirecomplex remains bound to the tube, while the unboundradioisotope remains in solution and is later decanted. Thebound radioactivity may then be quantitated using a gammacounter.In this procedure, the sample and buffer are pipetted into theantibody coated tube and incubated for forty-five (45) minutesat 37°C. The tubes are emptied, washed and filled with thecomplimentary antibody labeled with 125 I. After a second fortyfive(45) minute incubation period at 37°C, the tubes areemptied and washed twice to remove unbound 125 I labeledantibody. The emptied tubes are counted in a gamma counterand a standard curve is constructed from which unknownconcentrations of follicle stimulating hormone can becalculated.PRECISIONINTRA-ASSAY PRECISION (mIU/ml)LEVEL I LEVEL II LEVEL IIIn = 10 10 10mean = 13.1 35.0 68.6SD = 0.34 1.4 3.7%CV = 2.0 4.0 5.4INTER-ASSAY PRECISION (mIU/ml)LEVEL A LEVEL B LEVEL Cn = 10 10 10mean = 13.7 37.1 72.4SD = 1.1 2.2 3.3%CV = 8.0 5.9 4.6SPECIFICITY OF THE ANTISERUMThe following ligands have been checked for cross-reactivitywith this system. The percentages indicate the cross-reactivityobtained from the addition of 1000 mIU/ml of the ligands.COMPOUND% CROSS REACTIONhuman Follicle Stimulating Hormone 100.00human Luteinizing Hormone