Lippi Giuseppe, Luca Salvagno Gian, Blanckaert Norbert, Giavarina Davide, Green Sol, Kitchen Steve, Palicka Vladimir, Vassault Anne J, Plebani Mario
Clinical Chemistry Laboratory, University of Verona, Verona, Italy.
Clin Chem Lab Med. 2009;47(8):934-9. doi: 10.1515/CCLM.2009.218.
In vitro hemolysis, the prevailing cause of preanalytical error in routine laboratory diagnostics, might influence the reliability of several tests, affect the quality of the total testing process and jeopardize patient safety. Although laboratory instrumentation is now routinely equipped with systems capable of automatically testing and eventually correcting for hemolysis interference, to our knowledge there are no reports that have compared the efficiency of different analytical platforms for identifying and classifying specimens with hemolysis.
Serum from a healthy volunteer was spiked with varying amounts of hemolyzed blood from the same volunteer, providing a serum free hemoglobin concentration ranging from 0.0 g/L to 2.0 g/L as measured by the reference cyanmethemoglobin assay. The spiked serum samples were shipped to seven separate laboratories and the hemolysis index (HI) was tested in triplicate on the following analytical platforms: Roche Modular System P (n=4) and Integra 400 Plus (n=1), Siemens Dimension RxL (n=3), ADVIA 2400 (n=1) and ADVIA 1800 (n=1), Olympus AU 680 (n=1) and Coulter DXC 800 (n=1).
Satisfactory agreement of HI results was observed among the various analytical platforms, despite a trend toward overestimation by the ADVIA 2400 and 1800. After normalizing results according to the instrument-specific alert value, discrepancies were considerably reduced. All instruments except for the Dimension RxL gave values normalized to the instrument-specific alert value, <1.0 for the sample with 0.048 g/L free hemoglobin, and >1.0 for the sample with 0.075 g/L free hemoglobin. The results of the four Modular System P tests were also highly reproducible among the different facilities. When evaluating instruments that provided quantitative HI results, the mean intra-assay coefficient of variation (CV) calculated for the triplicate determinations was always between 0.1% and 2.7%.
The results of this multicenter evaluation confirm that efficiency of different analytical platforms to correctly identify and classify unsuitable samples is satisfactory. However, more effort should be placed on the standardization of reporting HI. All the instruments that we tested provide either quantitative or qualitative results that are essentially comparable, but which should always be compared with the instrument-specific alert values to harmonize their efficiency.
体外溶血是常规实验室诊断中分析前误差的主要原因，可能影响多项检测的可靠性，影响整个检测过程的质量，并危及患者安全。尽管实验室仪器现在通常配备了能够自动检测并最终校正溶血干扰的系统，但据我们所知，尚无报告比较不同分析平台识别和分类溶血标本的效率。
从一名健康志愿者采集的血清中加入不同量的同一志愿者的溶血血液，通过参考氰化高铁血红蛋白测定法测得血清游离血红蛋白浓度范围为0.0 g/L至2.0 g/L。将加标的血清样本送至七个独立实验室，并在以下分析平台上对溶血指数（HI）进行三次重复检测：罗氏Modular System P（n = 4）和Integra 400 Plus（n = 1）、西门子Dimension RxL（n = 3）、ADVIA 2400（n = 1）和ADVIA 1800（n = 1）、奥林巴斯AU 680（n = 1）和库尔特DXC 800（n = 1）。
尽管ADVIA 2400和1800有高估的趋势，但在各分析平台之间观察到HI结果具有良好的一致性。根据仪器特定的警报值对结果进行标准化后，差异显著减小。除Dimension RxL外，所有仪器给出的根据仪器特定警报值标准化后的值，对于游离血红蛋白为0.048 g/L的样本<1.0，对于游离血红蛋白为0.075 g/L的样本>1.0。四个Modular System P检测结果在不同机构之间也具有高度可重复性。在评估提供定量HI结果的仪器时，三次重复测定计算出的平均批内变异系数（CV）始终在0.1%至2.7%之间。
这项多中心评估的结果证实，不同分析平台正确识别和分类不适合样本的效率令人满意。然而，应更加努力实现HI报告的标准化。我们测试的所有仪器都提供本质上可比的定量或定性结果，但应始终与仪器特定的警报值进行比较，以协调它们的效率。
