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多参数重症监护检测分析仪的性能

Performance of a multi-profile critical care testing analyzer.

作者信息

Vanavanan Somlak, Chittamma Anchalee

机构信息

Division of Clinical Chemistry, Department of Pathology, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Clin Chem Lab Med. 2008;46(1):9-14. doi: 10.1515/CCLM.2008.003.

Abstract

BACKGROUND

Modern blood gas analyzers are often coupled to electrolyte and metabolite analyzers. We evaluated a Stat Profile Critical Care Xpress analyzer (STP CCX) for the rapid point-of-care measurement of blood gases (pH, pCO2, pO2, sO2), hematocrit (Hct), total hemoglobin (tHb), sodium (Na+), potassium (K+), chloride (Cl-), glucose (Glu), lactate (Lac), urea (BUN), ionized calcium (iCa) and ionized magnesium (iMg).

METHODS

The analyzer was evaluated in terms of imprecision and recovery using the STP CCX control. Fresh blood samples were also measured to determine the between-day imprecision. Correlation was assessed by clinical sample comparison with the Nova Stat Profile Ultra C and Dimension RxL systems for Cl- and BUN. We used Deming regression, correlation coefficients, mean differences, and the Wilcoxon signed-rank test for data analysis.

RESULTS

The coefficients of variation for all analytes were within desirable limits, ranging from 0.1% to 4.3%, and the recovery was 100%+/-3%. Between-day imprecision using fresh blood samples showed good results, ranging from 0.2% to 3.4%. The comparison results showed high to very high correlation. However, statistically significant mean differences with large bias were found for pCO2, pO2 and Cl-.

CONCLUSIONS

This analyzer is suitable as a simple and fast diagnostic tool in the laboratory and the critical care unit. However, users should be aware of biases that may lead to clinically significant errors in the assessment of acid-base status.

摘要

背景

现代血气分析仪通常与电解质和代谢物分析仪联用。我们评估了一款Stat Profile Critical Care Xpress分析仪(STP CCX)用于快速床旁检测血气(pH、pCO2、pO2、sO2)、血细胞比容(Hct)、总血红蛋白(tHb)、钠(Na+)、钾(K+)、氯(Cl-)、葡萄糖(Glu)、乳酸(Lac)、尿素(BUN)、离子钙(iCa)和离子镁(iMg)。

方法

使用STP CCX质控品对分析仪进行不精密度和回收率评估。还对新鲜血样进行检测以确定日间不精密度。通过与Nova Stat Profile Ultra C和Dimension RxL系统对临床样本中的Cl-和BUN进行比较来评估相关性。我们使用Deming回归、相关系数、平均差异和Wilcoxon符号秩检验进行数据分析。

结果

所有分析物的变异系数均在理想范围内,为0.1%至4.3%,回收率为100%±3%。使用新鲜血样的日间不精密度结果良好,为0.2%至3.4%。比较结果显示出高至非常高的相关性。然而,在pCO2、pO2和Cl-方面发现了具有较大偏差的统计学显著平均差异。

结论

该分析仪适合作为实验室和重症监护病房中简单快速的诊断工具。然而,用户应意识到可能导致酸碱状态评估出现临床显著误差的偏差。

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