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[临床酶学中结果一致性的改善:γ-谷氨酰转移酶、碱性磷酸酶和淀粉酶活性的多中心研究]

[Improvement of result coherence in clinical enzymology: multicenter study of gamma-glutamyltransferase, alkaline phosphatase and amylase activities].

作者信息

Lessinger J M, Férard G, Grafmeyer D, Labbé D, Maire I, Schiele F, Vassault A

机构信息

Laboratoire de biochimie appliquée, université Louis-Pasteur de Strasbourg, France.

出版信息

Ann Biol Clin (Paris). 1995;53(3):147-54.

PMID:7574101
Abstract

We report here on the results of a multicenter study of three enzyme activities (gamma-glutamyltransferase, alkaline phosphatase and amylase). For each activity, measurements were performed in two laboratories on different series of patients' specimens under routine conditions, at 30 and 37 degrees C, with techniques frequently used in France and with the IFCC reference method, when it exists. For each technique, precision was acceptable, but results differed considerably according to the technique used. The study also showed that for different techniques it is not possible to use a single transformation factor for activities between 30 and 37 degrees C. Patients' results determined by two techniques often showed a constant relationship. Groups of techniques that determined the same catalytic activity in patients' specimens were identified, whereas other techniques did not have this property. Several preparations, including reference materials produced by the Community Bureau of Reference (European Community, Brussels) and ten commercial secondary materials were tested for similar behaviour as compared to patients' samples. Results show the commutability of reference materials within a group of techniques indicating that they can be used as calibrators. This was seldom the case for the commercial secondary materials and we did not find any such material suitable for calibration of the three enzymatic activities. The present study demonstrates that with defined techniques and validated calibrators it is possible to reduce considerably differences between results obtained with different techniques at different temperatures and in different laboratories.

摘要

我们在此报告一项关于三种酶活性(γ-谷氨酰转移酶、碱性磷酸酶和淀粉酶)的多中心研究结果。对于每种酶活性,在常规条件下于两个实验室对不同系列的患者样本进行测量,温度为30摄氏度和37摄氏度,采用法国常用的技术以及国际临床化学和检验医学联合会(IFCC)的参考方法(若有)。对于每种技术,精密度是可接受的,但结果根据所使用的技术有很大差异。该研究还表明,对于不同技术,在30摄氏度和37摄氏度之间的活性不能使用单一的转换因子。由两种技术测定的患者结果通常呈现恒定关系。确定了在患者样本中具有相同催化活性的技术组,而其他技术不具备此特性。测试了几种制剂,包括欧洲共同体标准物质局(布鲁塞尔,欧洲共同体)生产的参考物质和十种商业二级物质,以比较它们与患者样本的类似行为。结果表明参考物质在一组技术内具有互换性,这表明它们可用作校准物。商业二级物质很少如此,并且我们未发现任何适合校准这三种酶活性的此类物质。本研究表明,使用明确的技术和经过验证的校准物,可以大幅减少在不同温度和不同实验室中使用不同技术获得的结果之间的差异。

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