Penton James R, Widdowson Graham M, Williams George Z
Research Institute of Laboratory Medicine Institute of Medical Sciences, San Francisco, Calif. 94115.
J Res Natl Bur Stand A Phys Chem. 1972 Sep-Oct;76A(5):491-498. doi: 10.6028/jres.076A.043.
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.
临床化学领域对分析方法的需求日益增长，要求其能够实现不同实验室之间以及同一实验室不同时间的结果比较。可靠的可比性需要对分光光度法和荧光法仪器及方法进行充分的标准化程序。本文讨论了化学和仪器标准化方面的问题。对于待测物质有合适形式的分析方法，一级化学标准化方法理所当然地受到欢迎。相对简单的仪器可用于将未知样品的测量结果与这些标准进行比较。由于许多具有临床意义的分析方法没有满足所有必要标准的一级标准物质，标准化必须依赖于所用仪器的精密度和准确度，以及所关注物质化学光学性质的准确汇编值。汇编任务超出了常规实验室的能力范围，应由可靠的中央机构提供。如果单个实验室要使用该机构汇编的值，那么该实验室必须具备精确、准确且价格合理的仪器，以及可靠的吸光度、荧光和波长校准标准。
