Gosling J P, Middle J, Siekmann L, Read G
Department of Biochemistry, University College, Galway, IE.
Scand J Clin Lab Invest Suppl. 1993;216:3-41.
The broad objectives of this report are to enhance the clinical utility of the results of hapten measurement immunoprocedures by encouraging standardization of the procedures. It was decided to restrict the subject of the report to one analyte, and cortisol was chosen because of its diagnostic importance, the need for improved comparability with routine procedures, and its relevance to many other analytes. Therefore, the immediate objectives are to improve the clinical utility of total serum cortisol concentrations measured on different occasions and in different laboratories, to make diagnostic reference intervals more reliable and widely applicable, and to improve diagnostic accuracy by: Improving the agreement between results from reference measurement procedures and the results obtained with normal routine immunoprocedures for the measurement of total serum cortisol, and hence the comparability of routine results; and Reducing the susceptibility of the immunoprocedures to crossreactivity and interference. It is recognized that good comparability of results depends on procedures which are specific, properly calibrated and validated, and that the most important factors are resistance to crossreactants and interferants. Analytical goals for cortisol immunoprocedures are zero bias for 'all' samples with respect to a reference procedures, with the total analytical standard deviation equal to, or less than, half the within-individual standard deviation for cortisol, or 7.6% according to a recent estimate. To these ends the group proposes the following measures: 1. An international network of reference laboratories for cortisol measurement should be established, and progressively developed to include other hapten analytes. The service of the participating laboratories would be necessary to make feasible other recommendations listed below. 2. Procedures should be comprehensively validated, including a thorough crossreactivity study with the results presented to indicate the possible significance of each crossreactivity, a direct comparison of results with those obtained by a reference procedure for an adequate number of varied fresh/frozen patient samples, and suitable clinical validation studies. 3. External quality assessment schemes should assess participating laboratory performance against reference procedure values, and not consensus values related to values determined by any group of participating procedures. They should also assess the ability to determine added standard and to resist common interferants. 4. Master calibrators for use in the production of calibrators included in commercial kits, and formulated identically to these, should be certified with at least one reference measurement procedure, so that the concentrations of analyte in calibrators can be traced back to concentrations determined by a reference procedure.(ABSTRACT TRUNCATED AT 400 WORDS)
本报告的总体目标是通过推动免疫程序标准化来提高半抗原测量免疫程序结果的临床实用性。决定将报告主题限定为一种分析物，选择皮质醇是因为其诊断重要性、与常规程序提高可比性的需求以及与许多其他分析物的相关性。因此，近期目标是提高在不同时间和不同实验室测量的总血清皮质醇浓度的临床实用性，使诊断参考区间更可靠且更具广泛适用性，并通过以下方式提高诊断准确性：提高参考测量程序结果与正常常规免疫程序测量总血清皮质醇结果之间的一致性，从而提高常规结果的可比性；降低免疫程序对交叉反应和干扰的敏感性。人们认识到，结果的良好可比性取决于特定、校准和验证得当的程序，且最重要的因素是对交叉反应物和干扰物的抗性。皮质醇免疫程序的分析目标是相对于参考程序，“所有”样本的偏差为零，总分析标准偏差等于或小于皮质醇个体内标准偏差的一半，或根据最近的估计为7.6%。为此，该小组提出以下措施：1. 应建立一个用于皮质醇测量的国际参考实验室网络，并逐步发展以纳入其他半抗原分析物。参与实验室的服务对于使以下列出的其他建议可行至关重要。2. 程序应进行全面验证，包括进行彻底的交叉反应研究，并呈现结果以表明每种交叉反应的可能意义，将结果与参考程序针对足够数量的不同新鲜/冷冻患者样本获得的结果进行直接比较，以及进行适当的临床验证研究。3. 外部质量评估计划应根据参考程序值评估参与实验室的性能，而不是根据任何一组参与程序确定的值的共识值。它们还应评估测定添加标准物和抵抗常见干扰物的能力。4. 用于生产商业试剂盒中校准物且配方与之相同的主校准物，应用至少一种参考测量程序进行认证，以便校准物中分析物的浓度可追溯到参考程序确定的浓度。（摘要截选至400字）
