Problems Associated With the Need for Standardization in Clinical Spectrophotometric and Fluorometric Measurements.

There is a growing demand in clinical chemistry for analyses to be performed in a manner allowing comparisons of results among laboratories and, from time to time, in the same laboratory. Reliable comparability requires adequate procedures of standardization for spectrophotometric and fluorometric instruments and methods. Problems with chemical and instrumental standardization are discussed. For assays where the substance to be measured is available in suitable form, primary chemical standardization is justifiably popular. Relatively unsophisticated instrumentation can be used to compare measurements of unknown samples with such standards. Because primary standards meeting all necessary criteria are not available for many assays of clinical significance, standardization must depend on precision and accuracy of the instrumentation used, and on accurately compiled values of chemical-optical properties for the materials of interest. The task of compilation is outside the capability of the routine laboratory and should be provided by a reliable central agency. If an individual laboratory is to use the agency's compiled values, that laboratory must have available precise, accurate and reasonably inexpensive instrumentation along with reliable absorbance, fluorescence, and wavelength calibration standards.