Flegar-Mestrić Zlata, Perkov Sonja
Institute of Clinical Chemistry, Merkur University Hospital, Zagreb, Croatia.
Clin Chem Lab Med. 2006;44(7):898-903. doi: 10.1515/CCLM.2006.148.
Rapid technological progress in point-of-care testing allows the measurement of multiple analytes in whole-blood samples. The present study evaluated biosensor-based methods for the measurement of electrolytes and substrates in whole blood using a Stat Profile Critical Care Xpress (Nova Biomedical, Waltham, MA, USA) multiprofile analyzer and their comparability with standard laboratory methods. Because of the increased utilization of arterial blood samples in hospitalized patients and limited information on differences between arterial and venous blood for most routine laboratory tests, analytical differences caused by different sample types were evaluated.
Whole-blood arterial samples and venous serum samples were obtained from 70 random patients with a variety of diagnoses admitted to the intensive care unit. The Stat Profile Critical Care Xpress analyzer was used to obtain whole-blood electrolyte and substrate profiles. For comparison studies, plasma or serum samples were analyzed according to standard laboratory methods using an Olympus AU 600 analyzer (Olympus Mishima, Shizuoka, Japan).
Imprecision, expressed as the coefficient of variation (CV%), was less than 5.7% for all analytes at both high and low concentrations, except for creatinine, with a CV of 13.8% for low and 9.5% for high concentrations. The inaccuracy of electrolyte and substrate measurements in whole blood using a Stat Profile Critical Care Xpress analyzer met the analytical quality specification required for near patient testing, with observed bias within the range -4.5% to 5.3%. Statistically significant correlation (p<0.05) was obtained between standard laboratory methods performed on arterial plasma or venous serum samples on an Olympus AU 600 analyzer and direct whole-blood measurements on the Stat Profile Critical Care Xpress point-of-care analyzer for all parameters tested, although slope and intercept values showed analytical differences for electrolyte measurement.
The Stat Profile Critical Care Xpress multiprofile point-of-care analyzer provides rapid and accurate direct whole-blood measurement with acceptable performance compared to standard laboratory methods. The results obtained for electrolytes and substrates in whole blood were comparable to those for standard laboratory methods using arterial plasma or venous serum samples.
即时检验技术的快速发展使得在全血样本中能够测量多种分析物。本研究使用Stat Profile Critical Care Xpress（美国马萨诸塞州沃尔瑟姆市的Nova Biomedical公司）多参数分析仪评估了基于生物传感器的全血电解质和底物测量方法，以及它们与标准实验室方法的可比性。由于住院患者动脉血样本的使用增加，且大多数常规实验室检测中关于动脉血和静脉血差异的信息有限，因此评估了不同样本类型引起的分析差异。
从70名入住重症监护病房、患有各种诊断疾病的随机患者中获取全血动脉样本和静脉血清样本。使用Stat Profile Critical Care Xpress分析仪获取全血电解质和底物谱。为进行比较研究，使用奥林巴斯AU 600分析仪（日本静冈县三岛市的奥林巴斯公司）按照标准实验室方法分析血浆或血清样本。
除肌酐外，所有分析物在高、低浓度下的不精密度（以变异系数[CV%]表示）均小于5.7%，肌酐低浓度时的CV为13.8%，高浓度时为9.5%。使用Stat Profile Critical Care Xpress分析仪进行全血电解质和底物测量的不准确性符合床旁检测所需的分析质量规范，观察到的偏差在-4.5%至5.3%范围内。对于所有测试参数，在奥林巴斯AU 600分析仪上对动脉血浆或静脉血清样本进行的标准实验室方法与在Stat Profile Critical Care Xpress床旁分析仪上进行的直接全血测量之间获得了具有统计学意义的相关性（p<0.05），尽管斜率和截距值在电解质测量方面显示出分析差异。
与标准实验室方法相比，Stat Profile Critical Care Xpress多参数床旁分析仪能够提供快速、准确的直接全血测量，性能可接受。全血中电解质和底物的测量结果与使用动脉血浆或静脉血清样本的标准实验室方法的结果具有可比性。
