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The AquaLite® Free T Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Free T . Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human free T4 in serum. The AquaLite® FT4 Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® F14 Assay) is an in vitro diagnostic product intended for use in the quantitative measurement of FT4 in human serum in clinical laboratories. Free thyroxine measurements are used to diagnosis and treat diseases of the thyroid.

The AquaLite® Free T. Assay is a single-site, competitive inhibition bioluminescent immunoassay kit. A T carrier complex is immobilized on polystyrene tubes (solid phase). Serum samples, appropriate calibrators or controls, are pipetted (50 uL) into the pre-coated tubes. A mouse monoclonal anti-T antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. Free T. in the sample competes with immobilized T for the available T binding sites of the anti-T antibody conjugate. Complex formation is complete after a 90-minute incubation period at room temperature 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. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The presence of Ta in the sample or calibrator reduces the binding of the conjugate to the immobilized T . pre-coated on the tubes. The amount of signal inhibition is indirectly proportional to the Free T concentration. To calculate results, the luminometer uses a cubic spline curve fit applied to a log-log transformation of the light intensity (in relative light units, RLU) of the Free T calibrators versus Free T, concentration (in ng/dL).

The AquaLite® hGH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® hGH Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human growth hormone in serum. Human Growth Hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland. The AquaLite® Human Growth Hormone Assay is for in vitro diagnostic use.

The AquaLite® hGH Bioluminescent Immunoassay Kit uses a mouse monoclonal anti-hGH antibody that is pre-coated onto polystyrene tubes (solid phase). Serum samples or appropriate calibrators or controls, are pipetted (150 uL) into the precoated tubes. A sheep anti-hGH antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. hGH in the sample combines with the 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 120-minute incubation period at room temperature 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. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of the hGH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the hGH calibrators is plotted against hGH concentration (in ng per mL) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to hGH concentration in ng/mL. Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

The AquaLite® Ferritin Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Ferritin Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human ferritin in serum and plasma. Ferritin measurements are used in the diagnosis of diseases affecting iron metabolism.

The AquaLite® Ferritin Bioluminescent Immunoassay Kit uses a mouse monoclonal antiferritin antibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma), or appropriate calibrators or controls, are pipetted (25 uL) into the precoated tubes. A mouse monoclonal anti-ferritin antibody covalently linked to AquaLite® (150 uL) is then added to the tubes. Ferritin in the sample simultaneously combines with the 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 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. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of the ferritin in the sample. To calculate results, the light intensity (in relative light units, RLU) of the ferritin calibrators is plotted against ferritin concentration (in ng per mL) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to ferritin concentration in ng/mL. Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

The AquaLite® Intact PTH Bioluminescent Immunoassay (BLA) Kit (or the AquaLite® Intact PTH assay) is intended to be used in clinical laboratories for the quantitative determination of human intact parathyroid hormone in serum mongunested, Intact PTH measurements are used in the diagnosis of disorders of calcium metabolism and the parathyroid gland. The AquaLite® Intact PTH assay is for in vitro diagnostic use.

The AquaLite® Intact PTH Bioluminescent Immunoassay Kit uses a goat polyclonal anti-PTH antibody that is pre-coated onto polystyrene tubes (solid phase). Serum samples, appropriate calibrators, and controls, are pipetted (100uL) into the pre-coated tubes. A second goat polyclonal anti-PTH antibody covalently linked to AquaLite® (150µL) is then added to the tubes. Intact PTH in the sample simultaneously combines with anti-PTH 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 120-minute incubation period at room temperature (18° 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. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of intact PTH in the sample. To calculate results, the luminometer uses a cubic spline curve fit applied to a logit-log transformation of the light intensity (in relative light units, RLU) of the intact PTH calibrators versus intact PTH concentration (in pg/mL).

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

The AquaLite® Prolactin Bioluminescent Immunoassay Kit uses a mixture of mouse monoclonal and rabbit polyclonal with anti-prolactin activity that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma), or appropriate calibrators or controls, are pipetted (25 uL) into the pre-coated tubes. Anti-prolactin conjugate consisting of mouse monoclonal antibody covalently linked to AquaLite® (150µL) is then added to the tubes. The conjugate uses the photoprotein, AquaLite® (recombinant aequorin: U.S. Patent Nos. 5,422,266 and 5,486,455) which is covalently linked to an anti-prolactin polyclonal antibody. Prolactin 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° 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 twosecond 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 prolactin in the sample. To calculate results, the luminometer uses a cubic spline curve fit applied to a logit-log transformation of the light intensity (in relative light units, RLU) of the prolactin calibrators versus prolactin concentration (in ng/mL). Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

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.

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

The AquaLite® LH Bioluminescent Immunoassay Kit uses a polyclonal anti-LH aitibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma and appropriate calibrators or controls, are pipetted (50 uL) into the pre-coated tubes. Anti-LH Conjugate (150uL) 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-LH monoclonal antibody. LH 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 LH in the sample. To calculate results, the light intensity (in relative light units. RLU) of the LH calibrators is plotted against LH concentration (in International Units per liter, IU/L) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to LH concentration in IU/L. Note that the numerical value for LH in mIU/mL is the same as for IU/L (International System). For example, 15.6 mIU/mL equals 15.6 IU/L. Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted with Calibrator A and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.