Department of Clinical Chemistry, Erasmus MC, University Medical Center, Rotterdam, the Netherlands.
Int J Lab Hematol. 2021 Feb;43(1):29-39. doi: 10.1111/ijlh.13339. Epub 2020 Sep 19.
In 2015, Sysmex launched a new series of hematology analyzers (XN-L Series) designed to fulfill the needs of niche laboratories in areas such as pediatrics, dialysis, neurology, and oncology while providing a compact solution. In this study, we evaluate the whole blood and body fluid modes of one of these analyzers, the XN-350.
A total of 300 residual EDTA samples were measured on the XN-350 in whole blood mode and the XN-1000 to evaluate method comparison, flagging sensitivity, repeatability, reproducibility, linearity, carryover, and stability. In addition, 191 samples were obtained and processed in body fluid mode which included, cerebrospinal fluid (CSF), continuous ambulatory peritoneal dialysis (CAPD), ascites, synovial, and pleural fluid to perform method comparison, repeatability, reproducibility, linearity, limit of quantitation, and carryover studies.
Strong agreement was shown between the XN-350 and XN-1000 for both whole blood and body fluid modes in results and flagging. Linearity results in both modes on the XN-350 showed a high R value (>.99). For WBC, RBC, HGB, and PLT, the carryover results were well within the predetermined criteria of ≤0.5% for whole blood and ≤0.3% for CSF. Repeatability and reproducibility were acceptable for both modes, and there were no significant deviations present in stability for whole blood. In addition, there was high agreement in all body fluid types evaluated.
The performance of the XN-350 is comparable to the XN-1000 in both whole blood and body fluid modes, making it a reliable alternative to larger analyzers for smaller, niche laboratories.
2015 年,希森美康推出了一系列新的血液分析仪(XN-L 系列),旨在满足儿科、透析、神经科和肿瘤科等领域的利基实验室的需求,同时提供紧凑的解决方案。在这项研究中,我们评估了其中一款分析仪 XN-350 的全血和体液模式。
共对 300 个 EDTA 残留样本在全血模式和 XN-1000 上进行了 XN-350 测量,以评估方法比较、标记灵敏度、重复性、再现性、线性、携带污染和稳定性。此外,还获得了 191 个体液模式的样本,包括脑脊液(CSF)、持续流动腹膜透析(CAPD)、腹水、滑液和胸腔积液,以进行方法比较、重复性、再现性、线性、定量限和携带污染研究。
XN-350 和 XN-1000 在全血和体液模式下的结果和标记均显示出很强的一致性。XN-350 两种模式的线性结果均显示出高 R 值(>.99)。对于 WBC、RBC、HGB 和 PLT,全血的携带污染结果均符合预定标准(≤0.5%),CSF 的携带污染结果均符合预定标准(≤0.3%)。两种模式的重复性和再现性均可以接受,全血的稳定性也没有明显偏差。此外,所有评估的体液类型均具有高度一致性。
XN-350 在全血和体液模式下的性能与 XN-1000 相当,是较小、利基实验室的大型分析仪的可靠替代方案。