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Optilite® Freelite Mx Kappa Free Kit: The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains in serum and urine aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE); and in serum aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings. Optilite® Freelite Mx Lambda Free Kit: The Optilite Freelite Mx Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains in serum and urine aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE); and in serum aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS). Results of the free light chain measurements should always be interpreted in conjunction with other laboratory and clinical findings.

The determination of soluble antigen concentration by turbidimetric methods involves the reaction with specific antiserum to form insoluble complexes. When light is passed through the suspension formed a portion of the light is transmitted and focused onto a photodiode by an optical lens system. The amount of transmitted light is indirectly proportional to the specific protein concentration in the test sample. Concentrations are automatically calculated by reference to a calibration curve stored within the instrument.

This kit is intended for the quantitative in vitro determination of human IgA in serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

Human IqA liquid reagent kit for use on SPAPLUS® comprises the following reagents: Antiserum: Monospecific goat anti IgA supplied in stabilised liquid form. lt contains 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine as preservatives. Calibrator and Controls: These consist of pooled human serum and are supplied in stabilised liquid form. The concentration of IgA given on the quality control certificate has been obtained by comparison with European Reference Material ERM-DA470k. They contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite IgA Kit comprises the following reagents: Antiserum: Goat anti IgA supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The Optilite IgM Kit is intended for the quantitative in vitro measurement of IgM in human serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgM aids in the diagnosis of abnomal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

The Optilite IgM Kit comprises the following reagents: Antiserum: Goat anti IgM supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

This kit is intended for the quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.

The SPAPlus IgM Kit comprises the following reagents: Antiserum: Goat Anti-IgM is supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide. 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.

The Optilite IgM CSF Kit comprises the following reagents: Latex Reagent: Supplied in stabilised liquid form. Preservatives: 0.025% sodium azide, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine, 0.05% ProClin. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.

The Optilite IgA CSF Kit is intended for the quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF) using the Optilite analyser.

The Optilite IgA CSF Kit comprises the following reagents: Latex Reagent, Calibrator and Controls, and Reaction Buffer.

The Optilite High Sensitivity C-Reactive Protein Kit is intended for the quantitative in vitro measurement of C-Reactive Protein in serum using the Binding Site Optilite analyser for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite High Sensitivity C-Reactive Protein Kit is comprised of latex reagent, single calibrator, controls (high and low) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.

The Optilite Freelite Mx Kappa Free Kit is intended for the quantitative in vitro measurement of Kappa free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. The Optilite Freelite Mx Lambda Free Kit is intended for the quantitative in vitro measurement of Lambda free light chains in serum and urine using the Binding Site Optilite analyser. Measurement of free light chains aids in the diagnosis and monitoring of multiple myeloma, lymphocytic neoplasms, Waldenström's macroglobulinaemia, AL amyloidosis, light chain deposition disease and connective tissue diseases such as systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings.

The Optilite Freelite Mx Kappa Free Kit is comprised of the following reagents: Latex Reagent: Sheep anti-Human Kappa (polyclonal monospecific) antibody (F(ab')2 fragment) bound to 200nm polystyrene latex particles. In 0.033M Glycine buffered saline pH8 (containing Sodium Azide (0.033%), Proclin (0.05%), Benzamidine (0.01%) and EACA (0.1%) as preservative plus BSA (0.033%)). Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. Reaction Buffer: Containing 0.099% sodium azide as a preservative. The Optilite Freelite Mx Lambda Free Kit is comprised of the following reagents: Latex Reagent: Sheep anti-Human Lambda (polyclonal monospecific) Free antibody (F(ab')2 fragment) bound to 200nm polystyrene latex particles. In 0.033M Glycine buffered saline pH8 (containing Sodium Azide (0.033%), Proclin (0.05%), Benzamidine (0.01%) and EACA (0.1%) as preservatives plus BSA (0.1665%)). Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. Reaction Buffer: Containing 0.099% sodium azide as a preservative. Note - In Optilite Freelite kits, the latex reagent and reaction buffer are supplied in a single wedge with a chamber for each fluid. They are therefore labelled as a single component Optilite Kappa Free Mx Reagent or Optilite Lambda Free Mx Reagent.

The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following: Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0. Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives. The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.