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Clinical Chemistry 34: 1733-1736, 1988;
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Clinical Chemistry, Vol 34, 1733-1736, Copyright © 1988 by American Association for Clinical Chemistry

Desirable performance characteristics and clinical utility of immunoglobulin and light-chain assays derived from data on biological variation

RP Ford, PE Mitchell and CG Fraser
Department of Biochemical Medicine, Ninewells Hospital, Dundee, Scotland.

Using automated assays of IgG, IgA, and IgM, and kappa (kappa) and lambda (lambda) light-chains, we assessed the analytical, intra- individual, and interindividual components of variation in a cohort of 12 apparently healthy subjects to examine the utility of the Kallestad Immunochemical Evaluation system. The immunoglobulins and light-chains had small intra-individual variation, and, in consequence, good analytical precisions (CV) of 2.3%, 2.5%, 3.0%, 2.4%, and 2.4% are required for IgG, IgA, IgM, kappa, and lambda assays, respectively. All of these analytes, and the derived kappa/lambda and heavy-/light-chain ratios, have marked individuality. Conventional population-based reference values are of limited utility; therefore, the assays are unlikely to have high diagnostic sensitivity but will be very useful for monitoring individuals. The kappa/lambda ratio may be of particular value in monitoring because a change exceeding 4% does imply a significant (P less than or equal to 0.05) difference in serial results.




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Copyright © 1988 by the American Association for Clinical Chemistry.