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台式散射比浊免疫分析分析仪的评估

Evaluation of a bench-top nephelometric immunoassay analyzer.

作者信息

van Rijn J L, van Landeghem A A, Goldschmidt H M

机构信息

Department of Clinical Chemistry and Hematology, St. Elisabeth Hospital, Tilburg, The Netherlands.

出版信息

J Clin Lab Anal. 1991;5(1):3-13. doi: 10.1002/jcla.1860050103.

DOI:10.1002/jcla.1860050103
PMID:1999760
Abstract

We evaluated the Technicon DPA-1 immunoassay analyzer on its analytical characteristics. Therefore we studied three assays: albumin in cerebrospinal fluid and IgG and transferrin in serum. When tested with the Cusum test for linearity albumin, IgG, and transferrin measurements showed no deviation from linearity. Closer examination revealed an abrupt difference of recovery (from 99 to 87%) in the albumin assay when the automatic dilution changed over from the primary analytical to the high analytical concentration range. One calibration was found sufficient for at least 14 days of measurement. Imprecision was well below the critical limits for reproducibility. We found reasonable agreement between the results from the DPA-1 and the results from comparison methods. However, the correlation plot of IgG showed lack of fit at a distinct segment of the regression line. This appeared to be caused by the poor recovery of the DPA-1 at the lower limit of the high analytical concentration range. The assays of IgG and transferrin were found insensitive for interference by hemoglobin, triglycerides, urea, and bilirubin. The albumin assay was found sensitive for bilirubin and triglycerides. No reagent- and sample-to-sample carry-over could be detected in the assays evaluated.

摘要

我们评估了Technicon DPA - 1免疫分析分析仪的分析特性。因此,我们研究了三项检测:脑脊液中的白蛋白以及血清中的IgG和转铁蛋白。当用累积和检验法检测线性时,白蛋白、IgG和转铁蛋白的测量结果未显示出与线性的偏差。进一步检查发现,当自动稀释从主要分析浓度范围转换到高分析浓度范围时,白蛋白检测中的回收率出现了突然变化(从99%降至87%)。发现一次校准足以进行至少14天的测量。不精密度远低于可重复性的临界限度。我们发现DPA - 1的结果与比较方法的结果之间具有合理的一致性。然而,IgG的相关图显示在回归线的一个明显段缺乏拟合。这似乎是由于DPA - 1在高分析浓度范围下限的回收率不佳所致。发现IgG和转铁蛋白检测对血红蛋白、甘油三酯、尿素和胆红素的干扰不敏感。发现白蛋白检测对胆红素和甘油三酯敏感。在所评估的检测中未检测到试剂和样品间的残留。

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