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三种凝血分析仪上的HIL干扰以及用于常规凝血检测的分析前模块的作用

HIL Interferences on Three Hemostasis Analyzers and Contribution of a Preanalytical Module for Routine Coagulation Assays.

作者信息

Nagant Carole, Rozen Laurence, Demulder Anne

出版信息

Clin Lab. 2016 Oct 1;62(10):1979-1987. doi: 10.7754/Clin.Lab.2016.160313.

Abstract

BACKGROUND

Preanalytical issues are a major part of routine coagulation laboratory errors. Automation in detection of preanalytical problems, including hemolysis, icterus and lipemia (HIL), improper tube fill volume, and undue clotting, has recently been implemented on specific hemostasis instruments. The aim of this study was to assess the added value of a new preanalytical module integrated into hemostasis analyzers compared to visual inspection of samples.

METHODS

The detection of preanalytical issues was performed by visual or manual inspection of the samples and by the new preanalytical module integrated on the ACL TOP 550. Additional tests were done to evaluate the interference of hemoglobin (Hb), bilirubin or triglycerides (TG). Plasma pools containing the interference substance were tested for routine coagulation assays on the STA-R Evolution, CS-5100, and ACL TOP 550.

RESULTS

Visual or manual inspection detected statistically less samples with preanalytical issues than the new preanalytical module integrated on the ACL TOP 550 (3.5% vs. 6.6%, p < 0.001). The majority of the samples were rejected for poor filling. HIL interferences appeared on assays when the concentration of Hb, bilirubin or TG exceeded a certain threshold that was analyzer and reagent dependent.

CONCLUSIONS

Automatic and standardized check of routine coagulation samples by ACL TOP 550 increased the accuracy and consistency in detection of preanalytical issues as compared to visual inspection only. The main advantages were the detection of insufficient filled tubes and icteric samples that are not detected visually.

摘要

背景

分析前问题是常规凝血实验室误差的主要部分。近期,特定的止血仪器已实现对分析前问题的自动化检测,包括溶血、黄疸和脂血(HIL)、采血管填充量不当以及过度凝血等情况。本研究的目的是评估集成于止血分析仪的新型分析前模块相较于样本目视检查的附加价值。

方法

通过对样本进行目视或人工检查以及利用集成在ACL TOP 550上的新型分析前模块来检测分析前问题。还进行了额外测试以评估血红蛋白(Hb)、胆红素或甘油三酯(TG)的干扰情况。对含有干扰物质的血浆池在STA-R Evolution、CS-5100和ACL TOP 550上进行常规凝血检测。

结果

与集成在ACL TOP 550上的新型分析前模块相比,目视或人工检查在统计学上检测出的存在分析前问题的样本较少(3.5%对6.6%,p < 0.001)。大多数样本因填充不佳而被拒收。当Hb、胆红素或TG的浓度超过某个取决于分析仪和试剂的阈值时,检测中会出现HIL干扰。

结论

与仅进行目视检查相比,ACL TOP 550对常规凝血样本进行自动和标准化检查提高了分析前问题检测的准确性和一致性。主要优势在于能够检测出目视无法发现的采血管填充不足样本和黄疸样本。

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