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确定西门子 Advia 2400 化学分析仪生化检测的溶血指数阈值。

Determination of hemolysis index thresholds for biochemical tests on Siemens Advia 2400 chemistry analyzer.

机构信息

Department of clinical laboratory, Characteristic Medical center of Chinese People's Armed Police Force, Pingjin Hospital, Tianjin, China.

出版信息

J Clin Lab Anal. 2019 May;33(4):e22856. doi: 10.1002/jcla.22856. Epub 2019 Feb 19.

Abstract

BACKGROUND

In vitro hemolysis is still the most common source of pre-analytical nonconformities. This study aimed to investigate the hemolytic effects on commonly used biochemical tests as well as to determine the hemolysis index (HI) thresholds on Siemens Advia 2400 chemistry analyzer.

METHODS

Peripheral blood samples were collected from forty healthy volunteers. Hemolysis was achieved using syringes. Five hemolysis levels were produced including the no hemolysis group, slight hemolysis group, mild hemolysis group, moderate hemolysis group, and heavy hemolysis group. We then used the bias from baseline (no hemolysis) and HI to construct regression functions. The HI corresponding to the bias limits was considered as HI thresholds. We chose the total allowable error (TAE) as the bias limit.

RESULTS

Of the twenty-eight analytes, ten analytes had clinical significance. Creatine kinase-MB, creatine kinase, potassium, aspartate aminotransferase, and hydroxybutyrate dehydrogenase were all positively affected; the corresponding HI threshold was 45.2, 99.96, 4.07, 10.16, and 7.94, respectively. Lactate dehydrogenase was also positively interfered, but we failed to calculate the HI threshold. Total bile acid, uric acid, and sodium were all negatively affected, and the HI threshold was 42.23, 500 and 501.8, respectively. Glucose was also negatively interfered, but it failed to achieve the HI threshold.

CONCLUSIONS

When the HI value was higher than its threshold, the corresponding analyte was considered inappropriate for reporting. The implementation of the assay-specific HI thresholds could provide an accurate method to identify analytes interfered by hemolysis, which would improve clinical interpretations and further boost laboratory quality by reducing errors associated with hemolysis.

摘要

背景

体外溶血仍然是最常见的分析前不符合的原因。本研究旨在调查常用生化检测的溶血效应,并确定西门子 Advia 2400 化学分析仪的溶血指数(HI)阈值。

方法

从 40 名健康志愿者中采集外周血样本。使用注射器实现溶血。产生 5 个溶血水平,包括无溶血组、轻度溶血组、轻度溶血组、中度溶血组和重度溶血组。然后使用与基线(无溶血)的偏差和 HI 构建回归函数。将与偏差限制相对应的 HI 视为 HI 阈值。我们选择总允许误差(TAE)作为偏差限制。

结果

在 28 项分析物中,有 10 项具有临床意义。肌酸激酶同工酶-MB、肌酸激酶、钾、天门冬氨酸氨基转移酶和羟丁酸脱氢酶均受到正向影响;相应的 HI 阈值分别为 45.2、99.96、4.07、10.16 和 7.94。乳酸脱氢酶也受到正向干扰,但未能计算出 HI 阈值。总胆汁酸、尿酸和钠均受到负向影响,HI 阈值分别为 42.23、500 和 501.8。葡萄糖也受到负向干扰,但未能达到 HI 阈值。

结论

当 HI 值高于其阈值时,相应的分析物被认为不适合报告。实施特定于检测的 HI 阈值可以提供一种准确的方法来识别受溶血干扰的分析物,从而通过减少与溶血相关的错误来改善临床解释并进一步提高实验室质量。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/23e2/6589729/02a28e738359/JCLA-33-e22856-g001.jpg

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