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FSH Menopausal Test is a rapid Step The One chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine to aid in the detection of the onset of menopause. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH. This device is intended for both professional and lay person use.

One Step FSH Menopausal Test is a rapid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone (FSH) in urine. The test utilizes a combination of antibodies including mouse monoclonal anti-FSH antibodies and goat polyclonal anti-mouse antibodies to selectively detect elevated levels of FSH.

The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with changes in menopause. This kit provides a preliminary screening result. This kit is intended for over-the-counter sales.

Immunoassay for the qualitative detection of FSH in urine.

FSH Menopause Predictor Test is a qualitative, one-step, midstream assay for the detection of Follicle Stimulating Hormone (FSH) in urine to be used as an aid in predicting menopause. The FSH Menopause Predictor Test is intended for over-the-counter use by the lay consumer.

The FSH Menopause Predictor Test is a midstream test used for the qualitative measurement of FSH and the detection of Follicle Stimulating Hormone in a woman's urine as an aid in predicting menopause. The FSH predictor test is intended for use outside the body (in vitro diagnostic use) by women at home. FSH Menopause Predictor is an over-the-counter (OTC) device and may be sold under various private labels.

The Moments Menopause Check is an in-vitro diagnostic screen for the detection of FSH (follicle stimulating hormone) in urine. Change in FSH levels may be associated with stages in menopause. This kit provides a preliminary result for the detection/presence of FSH in urine. It is intended for over-the-counter sales.

Immunoassay for the qualitative detection FSH (follicle stimulating hormone) in urine. The Moments Menopause Check, like many commercially available FSH screening test kits, qualitatively measures the presence of FSH by visual color sandwich one step immunoassay technology.

EarlyDETECT MENOPAUSE TEST is a qualitative rapid membrane immunoassay for the in vitro diagnostic detection of follicle stimulating hormone (FSH) in human urine as a confirmation of hormone changes related to the symptoms associated with the stages of menopause. This device is intended for professional and Over the Counter (OTC) use.

Rapid Membrane ImmunoAssay

The quantitative determination of follicle stimulating hormone (FSH) concentration in human serum and plasma by a microplate enzymeimmunoassay.Measurements of follicle-stimulating hormone are used in the diagnosis of pituitary gland and gonadotropin disorders.

Monobind Inc., registration number 2020726, plans to introduce Into commercial distribution an enzymeimmunoassay (ELISA) kit for the determination of folliclestimulating hormone (FSH) in human serum and plasma. The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing monoclonal blotinylated anti-FSH antibody, the enzyme-labeled anti-FSH antibody and a serum containing the native antigen (FSH), reaction results between the native antigen (FSH) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well Is directly proportional to the native antigen (FSH) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.

The AquaLite® FSH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® FSH assay) is intended to be used in clinical laboratories for the quantitative determination of human FSH in sera and plasma. The AquaLite® FSH assay is for in vitro diagnostic use.

The AquaLite® FSH Bioluminescent Immunoassay Kit uses a polyclonal anti-FSH antibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma) and appropriate calibrators or controls, are pipetted (25 µL) into the pre-coated tubes. Anti-FSH Conjugate (150 uL) is then added to the tubes. The conjugate uses the photoprotein. AquaLite® (recombinant aequorin; Patent Nos. 5, 422, 266 and 5, 486, 455) which is covalently linked to an anti-FSH monoclonal antibody. FSH in the sample simultaneously combines with polyclonal antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 60-minute incubation period at room temperature (18°C to 25°C) on a standard orbital shaker. The tubes are then washed to remove unbound conjugate. The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. An injected calcium trigger solution causes AquaLite® to oxide its self-contained luciferin molecule. This reaction produces a flash of light at 469 nm. which is measured by the luminometer. The intensity of the light is directly proportional to the concentration of the FSH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the FSH calibrators is plotted against FSH concentration (in International Units per liter. IU/L) to vield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to FSH concentration in IU/L.

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

Sandwich principle. Total duration of assay: 18 minutes. • 1st incubation (9 min.): 40 µL of sample, a biotinylated monoclonal FSH-specific antibody (80 µL) and a monoclonal FSH-specific antibody labeled with a ruthenium complex (50 µL)** react to form a sandwich complex. •2nd incubation (9 min.): after addition of streptavidin-coated microparticles (30 µL), the complex becomes bound to the solid phase via interaction of biotin and streptavidin. **Tris(2,2'-bipyridyl)ruthenium(II) complex (Ru(bpy)) 2+ 3 •The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame). •Results are determined via a calibration curve which is instrument- specifically generated by 2-point calibration and a master curve provided via the reagent bar code.