Division of Laboratory Medicine, Chiba University Hospital, Chiba, Japan; Clinical Proteomics Research Center, Chiba University Hospital, Chiba, Japan; Department of Molecular Diagnosis, Graduate School of Medicine, Chiba University, Chiba, Japan.
Division of Laboratory Medicine, Chiba University Hospital, Chiba, Japan.
Clin Chim Acta. 2015 Feb 20;441:44-6. doi: 10.1016/j.cca.2014.12.013. Epub 2014 Dec 15.
Recently, to detect abnormal reactions and failures of the device in biological analysis, a reaction data monitoring system has been provided for automated biochemical analyzers. We investigated the usefulness of this function for total-bilirubin (T-Bil) measurement in routine testing.
Abnormal reactions of T-Bil were detected in the reaction data over time based on the following items: whether the absorbance variance after mixing of the first reagent and sample exceeds the cut-off value.
In the cases in which the abnormal reaction was observed, the absorbance rapidly rose because of turbidity after mixing the sample with Reagent-1. The measured value was higher than the actual T-Bil level, for which the analyzer showed a warning mark with the output data. When this particular serum sample was subjected to immunofixation electrophoresis, the presence of a monoclonal protein was confirmed. We encountered seven similar cases out of 30,731 samples.
The reaction data monitoring system of the automated biochemical analyzers was useful to prevent false reports (misdiagnosis) due to unpredictable problems during T-Bil measurement. It was also suggested that detection of false reaction with a reagent may be a clue to find a new pathology, such as monoclonal gammopathy.
最近，为了检测生物分析中设备的异常反应和故障，已经为自动化生化分析仪提供了反应数据监测系统。我们研究了该功能在常规测试中用于总胆红素（T-Bil）测量的有用性。
根据以下项目，通过随时间变化的反应数据来检测 T-Bil 的异常反应：混合第一试剂和样品后吸光度变化是否超过截止值。
在观察到异常反应的情况下，由于样品与试剂 1 混合后浊度的原因，吸光度迅速升高。测量值高于实际的 T-Bil 水平，分析仪会在输出数据中显示警告标记。当对该特定血清样本进行免疫固定电泳时，证实存在单克隆蛋白。在 30731 个样本中，我们遇到了 7 个类似的情况。
自动化生化分析仪的反应数据监测系统有助于防止由于 T-Bil 测量过程中不可预测的问题导致的错误报告（误诊）。此外，检测试剂的假反应可能是发现新病理学的线索，例如单克隆丙种球蛋白病。
