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临床化学中的外部质量评估:克罗地亚的情况回顾,特别提及设备

External quality assessment in clinical chemistry: review of the situation in Croatia with particular reference to equipment.

作者信息

Juretić D, Cepelak I, Flegar-Mestrić Z

机构信息

Farmaceutsko-biokemijski fakultet, Zavod za medicinsku biokemiju i hematologiju, Sveuciliste u Zabrebu, Croatia.

出版信息

Clin Chem Lab Med. 1999 Jun;37(6):667-73. doi: 10.1515/CCLM.1999.104.

DOI:10.1515/CCLM.1999.104
PMID:10475076
Abstract

The effect of the use of new flame photometers (Ciba Corning 480, Chiron, Salzburg, Austria) and multichannel analyzers (BM Hitachi 904 or BM Hitachi 911, both Boehringer GmbH, Mannheim, Germany) on analytical quality was assessed in a number of medical biochemical laboratories (n=58) at health centers and general hospitals that provide primary health care services for the respective catchment areas. The laboratories were supplied during 1996 and 1997 with new equipment, as part of the First Croatian Health Project, Primary Health Care Subproject, carried out by the Croatian Ministry of Health and Croatian Institute of Health Insurance. We evaluated analytical performance of these laboratories for 19 analytes, according to the results reported in the Croatian External Quality Assessment Program for medical biochemical laboratories, performed four times per year. Changes of percentages of particular methods used by the participating laboratories were observed for inorganic phosphate, total bilirubin, urea and creatinine. Such changes were even more pronounced for enzymes, where changes in the measurement procedure such as incubation temperature and buffers were observed in the methods used. Evaluation of method performance revealed that after the introduction of new equipment interlaboratory variation decreased, so that an increasing proportion of laboratories included in the Project produced results within the target limits.

摘要

在为各自服务区域提供初级卫生保健服务的多个健康中心和综合医院的医学生化实验室(n = 58)中,评估了使用新型火焰光度计(奥地利萨尔茨堡奇隆公司的Ciba Corning 480)和多通道分析仪(德国曼海姆勃林格公司的BM Hitachi 904或BM Hitachi 911)对分析质量的影响。作为克罗地亚卫生部和克罗地亚健康保险研究所实施的克罗地亚第一个健康项目初级卫生保健子项目的一部分,在1996年和1997年期间,为这些实验室提供了新设备。根据克罗地亚医学生化实验室外部质量评估计划每年进行四次的报告结果,我们评估了这些实验室对19种分析物的分析性能。观察到参与实验室使用的特定方法在无机磷酸盐、总胆红素、尿素和肌酐方面的百分比变化。对于酶类,这种变化更为明显,在所使用的方法中观察到测量程序的变化,如孵育温度和缓冲液。方法性能评估显示,引入新设备后实验室间的差异减小,因此该项目中越来越多的实验室产生的结果在目标范围内。

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