Xiao Yi, Sun Chao, Tsan Justin, Leung Edward Ki Yun
Department of Pathology and Laboratory Medicine, Children's Hospital Los Angeles, 4650 Sunset Blvd, M/S #32, Los Angeles, CA 90027, USA.
Department of Pathology, University of Southern California Keck School of Medicine, Los Angeles, CA 90027, USA.
J Clin Med. 2024 Dec 19;13(24):7751. doi: 10.3390/jcm13247751.
N-terminal-proBNP (NT-proBNP) is a biomarker released into the blood in response to heart failure, reflecting the extent of cardiac stress and damage. QuidelOrtho Diagnostics released its latest reformulation of its NT-proBNP assay, the Vitros NT-proBNP II assay. This study aims to evaluate the analytical performance of the Vitros NT-proBNP II assay. : Repeatability, reproducibility, carryover, analytical measurement range, and clinical reportable range (AMR and CRR) were assessed using commercially available materials and dilution of patient specimens. Accuracy was evaluated by comparing results from the Vitros NT-proBNP II and the Vitros NT-proBNP assays. Paired heparin and EDTA plasma specimen results were compared, and instrument-to-instrument comparison was performed using two different Vitros 5600 Integrated Systems. NT-proBNP stability was evaluated at room temperature, 2-8 °C, and -18 °C for up to five days. : Repeatability and reproducibility were ≤10% CV, and no carryover was observed. The AMR was 20-30,000 pg/mL and dilution up to 80 times was verified. Passing-Bablok analysis showed a significant proportional bias with a slope of 1.37. Instrument-to-instrument and heparin-to-EDTA plasma comparisons showed no significant biases. NT-proBNP is stable up to five days at room temperature, 4 °C, and -20 °C. : Our evaluation demonstrated acceptable analytical performances of the Vitros NT-proBNP II assay except for the positive proportional bias compared with the Vitros NT-proBNP assay.
N 端前脑钠肽（NT-proBNP）是一种因心力衰竭而释放到血液中的生物标志物，反映心脏应激和损伤的程度。QuidelOrtho 诊断公司发布了其 NT-proBNP 检测的最新配方，即 Vitros NT-proBNP II 检测。本研究旨在评估 Vitros NT-proBNP II 检测的分析性能。：使用市售材料和患者标本稀释液评估重复性、再现性、携带污染、分析测量范围和临床报告范围（AMR 和 CRR）。通过比较 Vitros NT-proBNP II 和 Vitros NT-proBNP 检测的结果来评估准确性。比较了配对的肝素和乙二胺四乙酸（EDTA）血浆标本结果，并使用两台不同的 Vitros 5600 综合系统进行仪器间比较。在室温、2-8°C 和-18°C 下对 NT-proBNP 的稳定性进行了长达五天的评估。：重复性和再现性的变异系数（CV）≤10%，未观察到携带污染。AMR 为 20-30,000 pg/mL，验证了高达 80 倍的稀释度。Passing-Bablok 分析显示存在显著的比例偏差，斜率为 1.37。仪器间以及肝素与 EDTA 血浆的比较均未显示出显著偏差。NT-proBNP 在室温、4°C 和-20°C 下长达五天都是稳定的。：我们的评估表明，除了与 Vitros NT-proBNP 检测相比存在正的比例偏差外，Vitros NT-proBNP II 检测的分析性能是可接受的。
