Multicenter evaluation of the cobas m 511 integrated hematology analyzer
Multicenter evaluation of the cobas m 511 integrated hematology analyzer
复制标题
DOI：
10.1111/ijlh.12903
复制
发表时间：
2018-12-01
影响因子：
3
通讯作者：
Russcher, Henk
中科院分区：
文献类型：
--
作者：
Bruegel, Mathias;George, Tracy I.;Russcher, Henk
cobas m511集成血液学分析仪使用自动数字显微镜进行全血细胞计数（CBC），白细胞（WBC）差异，网织红细胞计数和有核红细胞计数。这项多中心研究验证了cobas m511系统的分析性能。方法结果在4个临床点，使用临床剩余全血样本（n = 2546）和健康志愿者新鲜全血样本（n = 480），分析重复性、再现性、携带性、模式间比较、细胞形态学、白细胞临床敏感性和方法比较。对于白细胞临床敏感性，将cobas m 511系统自动CBC和WBC鉴别、系统标志、cobas m 511图像和染色cobas m 511载玻片与手工显微镜进行比较。使用Sysmex((R)) XN分析仪进行仪器间方法比较。重复性和再现性结果显示低变异性。没有明显的样本残留，开放/关闭模式之间没有差异。cobas m 511图像与cobas m 511载玻片形态学评估的总体一致性百分比（n = 163个样本）为95.6%,95.7%。与人工400细胞参考鉴别法（n = 439个样本）相比，cobas m 511自动鉴别法检测分布和/或形态异常的灵敏度和特异性分别为94.4%和74.6%，cobas m 511图像评估的灵敏度和特异性分别为95.9%和73.3%。单核细胞和嗜碱性细胞不一致。cobas m511与Sysmex XN系统数据之间的相关性非常好（大多数CBC参数的Pearson’s R >= 0.95）。结论cobas m511系统在临床实验室中性能稳定，适合临床常规使用。
Introduction The cobas m 511 integrated hematology analyzer conducts a complete blood count (CBC), white blood cell (WBC) differential, reticulocyte count, and nucleated red blood cell count using automated digital microscopy. This multicenter study validated the analytical performance of the cobas m 511 system. Methods Results Repeatability, reproducibility, carryover, mode-to-mode comparison, cytomorphology, WBC clinical sensitivity, and method comparison were analyzed at four clinical sites using residual whole blood clinical samples (n = 2546) and fresh whole blood from healthy volunteers (n = 480). For WBC clinical sensitivity, the cobas m 511 system automated CBC and WBC differential, system flags, cobas m 511 images, and stained cobas m 511 slides were compared with manual microscopy. Sysmex((R)) XN analyzers were used for interinstrument method comparison. Repeatability and reproducibility results showed low variability. There was no significant sample carryover and no difference between open/closed modes. The overall percentage agreement of morphology assessments with manual microscopy (n = 163 samples) was 95.6% for cobas m 511 images and 95.7% for cobas m 511 slides. The sensitivity and specificity for detecting distributional and/or morphological abnormalities were 94.4% and 74.6% for cobas m 511 automated differential, and 95.9% and 73.3% for cobas m 511 image assessment, compared with a manual 400-cell reference differential (n = 439 samples). Some discordance was seen for monocytes and basophils. Correlations between cobas m 511 and Sysmex XN system data were very good (Pearson's R >= 0.95 for most CBC parameters). Conclusion The cobas m 511 system performs robustly in the clinical laboratory and is suitable for routine clinical use.