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酶的能力验证。为标准化指明道路。

Proficiency testing of enzymes. Charting the way toward standardization.

作者信息

Lott J A, Tholen D W, Massion C G

机构信息

Department of Pathology, The Ohio State University, Columbus 43210-1228.

出版信息

Arch Pathol Lab Med. 1988 Apr;112(4):392-8.

PMID:3355340
Abstract

Laboratories participating in the College of American Pathologists Enzyme Survey (ES) and Comprehensive Chemistry Survey used diverse methods for the same analyte, resulting in a considerable range of values for the commonly performed enzyme measurements. Nevertheless, with the techniques developed for the ES, both the short-term (within-mailing) and long-term (between-mailings) coefficients of variation (CVs) can be determined. The ten-year experience of the ES has shown improvement in the short-term CV; however, long-term stability of enzyme testing requires more effort on the part of the instrument and reagent suppliers and participating laboratories. A reference material with an International Federation of Clinical Chemistry-established aspartate aminotransferase value, National Bureau of Standards RM 8430, is now available and was sent to three large peer groups as part of a special study. Correction of the results to the RM 8430 aspartate aminotransferase value resulted in reducing the range of data from peers using the duPont aca but not from those using the American Monitor KDA or Technicon SMAC. Based on our experience with the ES, goals of 5% for the short-term CV and 10% for the long-term CV are proposed; they are achievable by most laboratories and meet medical needs for biochemical screening. Fixed criteria for the evaluation of enzyme results appear to be appropriate given the way most enzyme data are used clinically.

摘要

参与美国病理学家学会酶类检测(ES)和综合化学检测的实验室对同一分析物采用了多种方法,导致常见酶类检测结果的取值范围相当大。然而,利用为ES开发的技术,可以确定短期(邮件发送期间)和长期(邮件发送间隔)变异系数(CV)。ES的十年经验表明短期CV有所改善;然而,酶类检测的长期稳定性需要仪器和试剂供应商以及参与实验室付出更多努力。现在有一种具有国际临床化学联合会确定的天冬氨酸氨基转移酶值的参考物质,国家标准局RM 8430,已作为一项特别研究的一部分发送给了三个大型同行小组。将结果校正为RM 8430天冬氨酸氨基转移酶值后,使用杜邦aca的同行的数据范围缩小了,但使用美国监测KDA或Technicon SMAC的同行的数据范围没有缩小。根据我们在ES方面的经验,建议短期CV目标为5%,长期CV目标为10%;大多数实验室都可以实现这些目标,并且满足生化筛查的医疗需求。考虑到大多数酶类数据的临床使用方式,固定的酶类结果评估标准似乎是合适的。

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