CellaVisionDC-1(DC-1,Sysmex,神户,日本)是新推出的数字形态分析仪,主要为中小型实验室开发。我们评估了精确度,定性性能,比较DC-1和手动计数之间的细胞计数,和DC-1的周转时间(TAT)。
使用跨越正常白细胞(WBC)范围的五个外周血涂片(PBS)载玻片,根据临床和实验室标准协会(CLSI)EP15-A3,EP15-Ed3-IG1和EP12-A2指南评估DC-1的精密度和定性性能.根据CLSIEP09C-ED3指南比较DC-1的细胞计数和手动计数。DC-1的TAT也与人工计数的TAT进行了比较。
DC-1显示出出色的精度(%CV,0.0-3.5%),高特异性(98.9-100.0%),在18个细胞类别(12个WBC类别和6个非WBC类别)中具有较高的阴性预测值(98.4-100.0%)。然而,DC-1在七个细胞类别中显示0%的阳性预测值(超细胞,骨髓细胞,早幼粒细胞,爆炸,浆细胞,有核红细胞,和身份不明)。DC-1与DC-1的最大绝对平均差异(%)人工计数为2.74。总TAT(min:s)在DC-1(8:55)和手动计数(8:55)之间是相当的。
这是第一项全面评估DC-1(包括其TAT)性能的研究。DC-1具有可靠的性能,可用于小到中等容量的实验室协助PBS审查。然而,在一些小区类别中,DC-1可能对小区验证产生不必要的工作负荷。
CellaVision DC-1 (DC-1, Sysmex, Kobe, Japan) is a newly launched digital morphology analyzer that was developed mainly for small to medium-volume laboratories. We evaluated the precision, qualitative performance, comparison of cell counts between DC-1 and manual counting, and turnaround time (TAT) of DC-1.
Using five peripheral blood smear (PBS) slides spanning normal white blood cell (WBC) range, precision and qualitative performance of DC-1 were evaluated according to the Clinical and Laboratory Standards Institute (CLSI) EP15-A3, EP15-Ed3-IG1, and EP12-A2 guidelines. Cell counts of DC-1 and manual counting were compared according to the CLSI EP 09C-ED3 guidelines, and TAT of DC-1 was also compared with TAT of manual counting.
DC-1 showed excellent precision (%CV, 0.0-3.5%), high specificity (98.9-100.0%), and high negative predictive value (98.4-100.0%) in 18 cell classes (12 WBC classes and six non-WBC classes). However, DC-1 showed 0% of positive predictive value in seven cell classes (metamyelocytes, myelocytes, promyelocytes, blasts, plasma cells, nucleated red blood cells, and unidentified). The largest absolute mean differences (%) of DC-1 vs. manual counting was 2.74. Total TAT (min:s) was comparable between DC-1 (8:55) and manual counting (8:55).
This is the first study that comprehensively evaluated the performance of DC-1 including its TAT. DC-1 has a reliable performance that can be used in small to medium-volume laboratories for assisting PBS review. However, DC-1 may make unnecessary workload for cell verification in some cell classes.