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使用美国国家标准与技术研究院(NIST)标准参考物质909a评估准确性时的问题及实际考量:有缺陷小瓶的报告

Problems and practical considerations in assessing accuracy with NIST SRM 909a: report of defective vials.

作者信息

De B K, Karr B A, Ghosn S, Copeland B E

机构信息

Department of Pathology, University of Mississippi, Jackson 39216, USA.

出版信息

Clin Chem. 1996 Nov;42(11):1832-7.

PMID:8906084
Abstract

During an experimental period of 12 months in 1992-1993, while we were comparing the effectiveness of monthly vs quarterly use of the National Institute for Standards and Technology Standard Reference Material (NIST SRM) 909a as an accuracy material for the projected 30-year Fernald Medical Monitoring Program, we encountered three random defective vials with a glucose recovery of less than 30% of the NIST-assigned value. Analysis with five different multichannel instruments confirmed the original finding. Concomitant glucose recovery from adjacent vials was 97%-104%, as determined by using the same instruments, reagents, calibrators, and quality-control criteria on the same days. Recoveries of uric acid and cholesterol were also low (53-75% and 75-80%, respectively) in the three defective vials. Other analytes were unaffected. Studies to identify the cause of the defective vials were carried out with microbiological, electron microscopic, and biochemical techniques. When used for accuracy studies, each vial of NIST SRM 909a should have a concomitant check for glucose recovery to detect whether the vial is defective.

摘要

在1992年至1993年为期12个月的实验期间,当我们比较每月使用与每季度使用美国国家标准与技术研究院标准参考物质(NIST SRM)909a作为预计为期30年的费纳德医学监测项目的准确度物质的有效性时,我们遇到了三个随机出现的有缺陷小瓶,其葡萄糖回收率低于NIST指定值的30%。使用五种不同的多通道仪器进行的分析证实了最初的发现。通过在同一天使用相同的仪器、试剂、校准物和质量控制标准,测定相邻小瓶的伴随葡萄糖回收率为97%-104%。在这三个有缺陷的小瓶中,尿酸和胆固醇的回收率也很低(分别为53%-75%和75%-80%)。其他分析物未受影响。我们采用微生物学、电子显微镜和生化技术对有缺陷小瓶的原因进行了研究。当用于准确度研究时,每个NIST SRM 909a小瓶都应进行葡萄糖回收率的伴随检查,以检测小瓶是否有缺陷。

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