Department of Haematology, London Health Sciences Centre, London, ON, Canada.
Int J Lab Hematol. 2012 Feb 23. doi: 10.1111/j.1751-553X.2012.01411.x.
The Beckman Coulter DxH 300™ is a hematology analyzer that performs a CBC and 3-part WBC differential and incorporates new electronic, algorithm and mechanical design.
This instrument was compared with the predicate analyzer (Coulter(®) A(c) ·Tdiff2) and the larger format Coulter LH780 analyzer. Of interest were flagging rates, clinical sensitivity, and accuracy of the WBC in the presence of interfering particles. The total sample set (n = 404) consisted of morphologically normal and hematologically abnormal patients.
Correlation of the DxH 300 with A(c) ·Tdiff2™ showed good agreement with all directly measured parameters. When compared with the LH780, WBC and platelets (PLT) counts showed good agreement with small biases. Importantly in the low range (PLT <50 × 10(9) /L), there was a small positive bias of only 2 × 10(9) /L PLT. Interfering particles did not affect the DxH 300 WBC count (P > 0.05) with strong correlations to the LH780 (r(2) values >0.95). Importantly, overall and specific flagging rates as well as false-negative and false-positive rates were significantly reduced on the DxH 300 compared with the A(c) ·Tdiff2 (27% and 41% reduction, respectively, P < 0.001).
The DxH 300 offers significant improvement over the predicate Coulter analyzer in flagging rates and improved correlation with larger format analyzers for WBC and PLT counts. Reduced false negatives and false positives significantly improved sensitivity and specificity compared to the predicate analyzer. The 28% improvement in flagging efficiency together with numerous software and data handling enhancements should translate into reduced need to perform follow-up analysis on a significant number of samples.
贝克曼库尔特 DxH 300™ 是一款血液分析仪，可进行全血细胞计数（CBC）和 3 分群白细胞（WBC）分类，并采用了新的电子、算法和机械设计。
该仪器与参比仪器（库尔特（®）A(c)·Tdiff2）和更大的格式 Coulter LH780 分析仪进行了比较。感兴趣的指标包括标记率、WBC 的临床灵敏度以及存在干扰颗粒时的准确性。总样本集（n=404）由形态正常和血液学异常的患者组成。
DxH 300 与 A(c)·Tdiff2™ 的相关性显示，所有直接测量参数均具有良好的一致性。与 LH780 相比，WBC 和血小板（PLT）计数具有较小的偏差，具有良好的一致性。重要的是，在低值范围（PLT<50×10(9)/L）中，PLT 仅出现 2×10(9)/L 的正偏差。干扰颗粒不会影响 DxH 300 的 WBC 计数（P>0.05），与 LH780 具有很强的相关性（r(2)值>0.95）。重要的是，与 A(c)·Tdiff2 相比，DxH 300 的总标记率和特定标记率以及假阴性和假阳性率均显著降低（分别降低 27%和 41%，P<0.001）。
与参比 Coulter 分析仪相比，DxH 300 在标记率方面有显著改进，与更大格式分析仪在 WBC 和 PLT 计数方面的相关性也有所提高。与参比分析仪相比，假阴性和假阳性的减少显著提高了灵敏度和特异性。标记效率提高了 28%，同时软件和数据处理方面也有了诸多改进，这应该会减少对大量样本进行后续分析的需求。
