Department of Laboratory Medicine, Konkuk University School of Medicine, Seoul, Korea.
Department of Laboratory Medicine, Chung-Ang University College of Medicine, Seoul, Korea.
Clin Chem Lab Med. 2022 Oct 31;61(1):133-141. doi: 10.1515/cclm-2022-0829. Print 2023 Jan 27.
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.
CellaVision DC-1（DC-1，希森美康，神户，日本）是一种新推出的数字形态分析仪，主要为中小容量实验室开发。我们评估了 DC-1 的精密度、定性性能、与手动计数的细胞计数比较以及周转时间（TAT）。
使用五个外周血涂片（PBS）跨越正常白细胞（WBC）范围，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 CLSI EP 09C-ED3 指南比较 DC-1 和手动计数的细胞计数，并比较 DC-1 的 TAT 与手动计数的 TAT。
DC-1 在 18 个细胞类别（12 个 WBC 类别和 6 个非 WBC 类别）中显示出优异的精密度（%CV，0.0-3.5%）、高特异性（98.9-100.0%）和高阴性预测值（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（中幼粒细胞、幼粒细胞、早幼粒细胞、原始细胞、浆细胞、有核红细胞和未识别）。DC-1 与手动计数的最大绝对平均差异（%）为 2.74。DC-1（8:55）和手动计数（8:55）的总 TAT（分钟：秒）相当。
这是第一项全面评估 DC-1 包括其 TAT 的性能的研究。DC-1 具有可靠的性能，可用于中小容量实验室协助 PBS 复查。然而，在某些细胞类别中，DC-1 可能会产生不必要的细胞验证工作量。
