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  • Title: Selecting the optimum specimen for assessing slight albuminuria, and a strategy for clinical investigation: novel uses of data on biological variation.
    Author: Howey JE, Browning MC, Fraser CG.
    Journal: Clin Chem; 1987 Nov; 33(11):2034-8. PubMed ID: 3677375.
    Abstract:
    To investigate the optimum specimen for quantifying low, but abnormal, concentrations of albumin in urine, we assessed the analytical and biological components of variation in first morning, random untimed, and 24-h urine specimens from 11 apparently healthy individuals. The results were expressed in terms of albumin concentration, albumin/creatinine ratio, and albumin excretion rate. Analytical methods generally can meet the analytical goal of CV less than or equal to 18%. For reasons detailed herein, we prefer measurement of the albumin concentration in the first morning specimen. Expressing results as an albumin/creatinine ratio has little advantage. Albumin concentrations in first morning urines from 16 diabetic subjects showed larger intra-individual variation than for nondiabetic subjects but clearly fell into two groups: those with consistently normal albumin concentrations in urine and those with abnormal concentrations in some specimens. The intrinsic biological variation of the latter group means that the ideal 100% nosological specificity cannot be achieved with any cutoff point without inclusion of a large proportion of the former. Qualitative testing with a latex-agglutination technique also demonstrates this problem. Use of data on biological variation allows development of an appropriate clinical strategy to investigate diabetic patients.
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