Laboratoire de Biochimie, CHU de Nantes, Nantes, France.
Clin Chem Lab Med. 2013 Feb;51(2):397-404. doi: 10.1515/cclm-2012-0201.
Point of care (POC) testing for fetal scalp blood lactate is a more user friendly and more successful approach compared to scalp pH for intrapartum fetal monitoring. The aim of this study was to assess the analytical specificity and clinical reliability of three POC lactate methods.
The analytical performance of three POC lactate methods was compared to Cobas 6000 (Roche Diagnostics) laboratory reference method: Lactate Pro from Arkray, GEM 4000 from Instrumentation Laboratory and StatStrip Lactate from Nova Biomedical. The clinical performance and influences on accuracy and decision making criteria for the three POC methods was assessed with umbilical cord samples and compared to the laboratory reference method. The influence of varying ranges of hemoglobin, pH and partial oxygen pressure (pO(2)) on the accuracy of results was assessed.
Although all three POC methods showed good correlation with the reference method for the umbilical cord sample population (r=0.989, 0.973 and 0.980, respectively), Lactate Pro and Gem 4000 showed a significant negative bias compared to the reference method. The degree of bias meant a significant readjustment of decision making criteria was required for fetal lactate use. The accuracy of the Lactate Pro results was affected by hemoglobin and to a lesser extent pH.
The three electrochemical POC devices can measure fetal lactate reliably. StatStrip Lactate showed a closer correlation and concordance to our laboratory reference method. The results of this study indicate the requirement for predetermining the reliability of POC lactate methods before use present in fetal and perinatal settings.
与头皮 pH 值相比，即时床旁检测（POC）胎儿头皮血乳酸检测对于产时胎儿监测来说是一种更便于用户使用且更成功的方法。本研究旨在评估三种 POC 乳酸检测方法的分析特异性和临床可靠性。
将三种 POC 乳酸检测方法的分析性能与 Cobas 6000（罗氏诊断公司）实验室参考方法进行比较：Arkray 的 Lactate Pro、Instrumentation Laboratory 的 GEM 4000 和 Nova Biomedical 的 StatStrip Lactate。使用脐带样本评估三种 POC 方法的临床性能及其对准确性和决策标准的影响，并与实验室参考方法进行比较。评估了血红蛋白、pH 值和部分氧分压（pO2）的变化范围对结果准确性的影响。
尽管三种 POC 方法在脐带样本人群中与参考方法均显示出良好的相关性（r 值分别为 0.989、0.973 和 0.980），但 Lactate Pro 和 Gem 4000 与参考方法相比显示出显著的负偏倚。这种偏倚程度意味着需要对胎儿乳酸使用的决策标准进行重大调整。Lactate Pro 结果的准确性受血红蛋白影响，受 pH 值影响较小。
三种电化学 POC 设备可可靠地测量胎儿乳酸。StatStrip Lactate 与我们的实验室参考方法具有更密切的相关性和一致性。本研究结果表明，在胎儿和围产期环境中使用之前，需要预先确定 POC 乳酸方法的可靠性。
