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The Optilite Hevylite IgM Kappa Kit is intended for the quantitative in vitro measurement of IgM kappa (combined mu heavy and k light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia. The Optilite Hevylite IgM Lambda Kit is intended for the quantitative in vitro measurement of IgM lambda (combined u heavy and a light chain) in serum using the Binding Site Optilite analyser. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia. The test result should be used in conjunction with other laboratory and clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.

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Hevylite Human IgM Kappa kit for use on SPAPLUS is intended for the in-vitro quantification of IgM kappa (combined u heavy and k light chain) concentration in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenström's macroglobulinaemia in conjunction with other clinical findings. This assay has not been established for the diagnosis of Waldenstrom's macroglobulinaemia. Hevylite Human IgM Lambda kit for use on SPAPLUS is intended for the in-vitro quantification of IgM lambda (combined u heavy and A light chain) in human serum on the Binding Site SPAPLUS. The test result is to be used with previously diagnosed Waldenstrom's macroglobulinaemia. The test result is to be used in conjunction with other clinical findings. This assay has not been established for the diagnosis, monitoring and prognosis of Waldenström's macroglobulinaemia.

Evaluating the concentration of a soluble antigen (e.g. IgM Kappa and IgM Lambda) by turbidimetry involves the addition of the test sample to a solution containing the appropriate antibody (anti-IgM kappa and anti-IgM lambda) in a reaction vessel or cuvette. A beam of light id passed through the cuvette and, as the antigen-antibody reaction proceeds, the light passing through the cuvette is scattered increasingly as insoluble immune complexes are formed. Light scatter is monitored by measuring the decrease in intensity of the incident beam of light. The antibody in the cuvette is in excess so the amount of immune complex formed is proportional to the antigen concentration. A series of calibrators of known antigen concentration are assayed initially to produce a calibration curve of measured light scatter versus antigen concentration. Samples of unknown antigen concentration can then be assayed and the results read from the calibration curve.