Jørgensen Bo, Bertsch Thomas, Bröker Hans-Joachim, Schäfer Markus, Chapelle Jean-Paul, Gadisseur Romy, Cowie Martin R, Dikkeschei Bert, Gurr Eberhard, Hayen Wiebke, Hafner Gerd, Stiegler Yuriko, Schönherr Hans-Robert, Strasser Ruth H, Weidtmann Britta, Folkerts Henning, Zugck Christian, Hofmann Kerstin, Zerback Rainer
Department of Clinical Biochemistry, Viborg Regional Hospital, Viborg, Denmark.
Clin Lab. 2012;58(5-6):515-25.
In the second generation of the point-of-care (POC) assay Roche CARDIAC proBNP, the upper limit of the measuring range was extended from 3000 to 9000 ng/L.
A thirteen-site multicentre evaluation was carried out to assess the analytical performance of the POC NT-proBNP assay and to compare it with a laboratory N-terminal pro-brain natriuretic peptide (NT-proBNP) assay.
In method comparisons of six lots of POC NT-proBNP with the lab reference method (Elecsys proBNP) mean bias ranged from -10 to +17%. In lot-to-lot comparisons all six investigated lots of POC NT-proBNP showed excellent agreement, with mean bias between -7% and +2%. The majority of all coefficients of variation obtained from ten-fold measurements using 56 native blood samples were below 8%. No interference was observed with hemolytic blood (hemoglobin concentrations up to 0.12 mmol/L), lipemic blood (triglyceride concentrations up to 14.0 mmol/L) nor icteric blood (bilirubin concentrations up to 63 micromol/L). Hematocrit values between 24% and 51% had no influence on the assay result. High NT-proBNP concentrations above the measuring range of POC NT-proBNP did not lead to false low results due to potential high-dose hook effect. Results with POC NT-proBNP were not influenced by different ambient temperatures (18 degrees C to 32 degrees C), the sample material used, nor by over- or underdosing by 15 microL compared to the regular sample volume of 150 microL.
The POC NT-proBNP assay showed an excellent analytical performance including a good agreement with the laboratory method. The assay is therefore suitable for its intended use in point-of-care settings.
在即时检测（POC）罗氏心脏肌钙蛋白原B型钠尿肽（proBNP）第二代检测中，测量范围的上限从3000 ng/L扩展至9000 ng/L。
开展了一项十三中心的多中心评估，以评估POC N末端B型钠尿肽原（NT-proBNP）检测的分析性能，并将其与实验室N末端脑钠肽前体（NT-proBNP）检测进行比较。
在六批POC NT-proBNP与实验室参考方法（罗氏电化学发光免疫分析proBNP检测法）的方法比较中，平均偏差范围为-10%至+17%。在批次间比较中，所有六批被研究的POC NT-proBNP均显示出极佳的一致性，平均偏差在-7%至+2%之间。使用56份天然血液样本进行十倍测量所获得的所有变异系数中，大多数低于8%。在血红蛋白浓度高达0.12 mmol/L的溶血血液、甘油三酯浓度高达14.0 mmol/L的脂血以及胆红素浓度高达63 μmol/L的黄疸血中均未观察到干扰。血细胞比容值在24%至51%之间对检测结果无影响。POC NT-proBNP测量范围以上的高NT-proBNP浓度不会因潜在的高剂量钩状效应导致错误的低结果。POC NT-proBNP的检测结果不受不同环境温度（18℃至32℃）、所用样本材料的影响，与150 μL常规样本体积相比，样本加样量多15 μL或少15 μL也不会对结果产生影响。
POC NT-proBNP检测显示出出色的分析性能，包括与实验室方法的良好一致性。因此，该检测适用于其在即时检测环境中的预期用途。
