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Clinical Chemistry 16: 1028-1032, 1970;
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Clinical Chemistry, Vol 16, 1028-1032, Copyright © 1970 by the American Association for Clinical Chemistry

Biological and Analytic Components of Variation in Long-Term Studies of Serum Constituents in Normal Subjects

III. Physiological and Medical Implications

Ernest Cotlove 1, Eugene K. Harris 1, and George Z. Williams 1

1 Clinical Pathology Department (E.C., G.Z.W.) and Laboratory of Applied Studies, Division of Computer Research and Technology (E.K.H.), National Institutes of Health, Bethesda, Md. 20014.

Biological components of variation for each of 15 serum constituents have been estimated in 68 normal subjects by weekly measurements over several months, and concurrent measurements on invariant human serum pools. Intra-individual coefficient of variation was smallest, less than 2%, for Na, Cl, Ca, Mg; 3 to 4% for CO2, albumin, and total protein; 5 to 7% for K, glucose, cholesterol, and phosphate; and largest, 9 to 12%, for uric acid, urea nitrogen, SGOT, and LDH. Inter-individual variation was larger than intra-individual variation for all 15 tests except Cl, CO2, and K. Analytic deviation was as large as or larger than biological (intra- or inter-individual) variability for constituents, such as calcium, which are under precise homeostatic control, thus producing artifactual widening in the observed normal range and obscuring the borderline between normal and abnormal results. Limits of tolerable variability in laboratory procedures are proposed, based on composite intra- and inter-individual variation, that would permit medically significant deviations in results to be detected. Such limits were exceeded by current methodology in at least half the 15 tests.


Key Words: homeostasis • normal values for common clinical laboratory tests • single vs. repetitive measurements • group vs. personal norms

Accepted on October 5, 1970




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