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放射免疫分析的质量控制——误差各组成部分的评估及其对总误差的贡献率

[Quality control of radioimmunoassay--evaluation of individual components of error and their contribution rates to total error].

作者信息

Sugisawa Y, Takahashi T, Ohaku T, Itoh M, Morishima E, Sohta Y

出版信息

Radioisotopes. 1984 Mar;33(3):130-6.

PMID:6473828
Abstract

Using Insulin RIA Kit (double antibody method, Dainabot Co., Ltd.), individual components of error due to pipetting of reagents, bound-free separation and counting were evaluated experimentally and theoretically. They were statistically synthesized to get the total response error relationship (RER). The resulting RER agreed well with the pooled RER obtained by the method reported previously. This good agreement indicates that individual components of error were reasonably and precisely estimated. Based on this result, contribution rates of individual components of error to the total response error were evaluated. The averaged contribution rates over the range to measure, when pipetting precision, C.V. (coefficient of variation) = 0.005, were 64% for counting error, 24% for bound-free separation error, and the error related with reagent delivery was only 12%. When C.V. = 0.01, however, which is considered normal pipetting precision, the contribution rate for the latter went up to 35%. Effect of poor precision in pipetting on final assay results is so great that much more attention than we usually think of should be paid to pipettes and pipetting techniques.

摘要

使用胰岛素放射免疫分析试剂盒(双抗体法,日本第一化学药品株式会社),对试剂移液、结合-游离分离及计数过程中产生的误差的各个组成部分进行了实验和理论评估。对这些误差进行统计学综合,以获得总响应误差关系(RER)。所得的RER与先前报道方法获得的合并RER吻合良好。这种良好的吻合表明误差的各个组成部分得到了合理且精确的估计。基于此结果,评估了误差各个组成部分对总响应误差 的贡献率。在测量范围内,当移液精密度的变异系数(C.V.)=0.005时,计数误差的平均贡献率为64%,结合-游离分离误差的平均贡献率为24%,与试剂移液相关的误差仅为12%。然而,当C.V.=0.01(这被认为是正常的移液精密度)时,后者的贡献率上升至35%。移液精密度不佳对最终检测结果的影响非常大,因此应比我们通常认为的更加关注移液器和移液技术。

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