Intra- and interindividual components of biological variation have been determined for total thyroxin (TT4), free thyroxin (FT4), total triiodothyronine (TT3), free triiodothyronine (FT3), and thyrotropin (TSH). Calculated analytical goals (CV, %) for the precision required for optimal patient care are: TT4 less than or equal to 2.5, FT4 less than or equal to 4.7, TT3 less than or equal to 5.2, FT3 less than or equal to 3.9, and TSH less than or equal to 8.1. The marked degree of individuality demonstrated for all hormones indicates that, if conventional population-based reference ranges are used uncritically, major changes in hormone concentration may not be correctly identified for some patients because observed values continue to lie within the reference range. At analyte concentrations approximating the mean values found in this study, and for analytical performance meeting the appropriate analytical goal, the differences required for consecutive results to be significantly different (p less than or equal to 0.5) have been calculated as: TT4, 14.7 nmol/L; FT4, 5.7 pmol/L; TT3, 0.6 nmol/L; FT3, 1.3 pmol/L, and TSH, 0.7 milli-int. unit/L.

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The analytical and biological components of variation of total cholesterol, high density lipoprotein (HDL) cholesterol, HDL3 cholesterol, HDL2 cholesterol and apolipoproteins A-I and B in serum were assessed in 12 apparently healthy individuals. All analytes showed marked individuality and therefore conventional population based reference intervals are of little use. The differences required for serial results to have changed significantly for these assays were calculated. The data presented confirm that the assays studied have limited value in screening the general population.

The effect of a rat high-density lipoprotein subfraction (HDL3 on the synthesis of bile salts by rat hepatocyte monolayers prepared from rats fed a diet containing cholestyramine, was investigated. The synthesis of bile salts as measured by radioimmunoassay of conjugated cholic, chenodeoxycholic and b-muricholic acids was significantly increased when hepatocytes were incubated with a physiological concentration (500 pg HDL, protein. ml-i) of HDL,. Rat hepatocyte monola_verBile salt synthesis

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.