Abstract：
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.
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.
摘要：
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。
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。
