Objectives: 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. Methods: 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. Results: 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). Conclusions: 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.
Digital morphology (DM) analyzers are widely applied in clinical practice. It is necessary to evaluate performances of DM analyzers by focusing on leukopenic samples. We evaluated the analytical performance, including precision, of a Sysmex DI-60 system (Sysmex, Kobe, Japan) on white blood cell (WBC) differentials in leukopenic samples. In a total of 40 peripheral blood smears divided into four groups according to WBC count (normal, mild, moderate, and severe leukopenia; each group n = 10), we evaluated precision of WBC preclassificaiton by DI-60. %coefficients of variation (%CVs) of precision varied for each sample and for each cell class; the fewer cells per slide, the higher %CV. The overall specificity and efficiency were high for all cell classes except plasma cells (95.9–99.9% and 90.0–99.4%, respectively). The largest absolute value of mean difference between DI-60 and manual count in each group was: 10.77, normal; 10.22, mild leukopenia; 19.09, moderate leukopenia; 47.74, severe leukopenia. This is the first study that evaluated the analytical performance of DI-60 on WBC differentials in leukopenic samples as the main subject. DI-60 showed significantly different performance depending on WBC count. DM analyzers should be evaluated separately in leukopenic samples, even if the overall performance was acceptable.
ABO incompatibility is not considered a contraindication for hematopoietic stem cell transplantation (HSCT). We hypothesized that recipient-derived isoagglutinin (RDI) levels could play a critical role in clinical outcomes. In this study, we compared clinical outcomes such as survival, GVHD, infection, relapse, transfusion, and engraftment, among ABO-compatible patients (ABOc), ABO-incompatible patients (ABOi) with low RDI, and ABOi patients with high RDI. The ABOi with high RDI group was defined as recipients with more than 1:16 RDI levels. We analyzed 103 recipients (ABOc, 53; ABOi with low RDI, 36; ABOi with high RDI, 14). The ABOi with high RDI group showed a decreased 1-year survival and increased acute GVHD grade IV and RBC transfusion (p = 0.017, 0.027, and 0.032, respectively). The ABOi with high RDI group was an independent risk factor for increased death, RBC transfusion, and poor platelet (PLT) engraftment (odds ratio (OR) = 3.20, p = 0.01; OR = 8.28, p = 0.02; OR = 0.18, p = 0.03, respectively). The ABOi with high RDI group showed significantly delayed PLT engraftment. In conclusion, this is the first study underscoring high RDI levels as a marker predicting unfavorable outcomes in ABOi HSCT.
Objectives: The EasyCell assistant (Medica, Bedford, MA, USA) is one of the state-of-the-art digital morphology analyzers. We explored the performance of EasyCell assistant in comparison with manual microscopic review and Pentra DX Nexus (Horiba ABX Diagnostics, Montpellier, France). Methods: In a total of 225 samples (100 normal and 125 abnormal samples), white blood cell (WBC) differentials and platelet (PLT) count estimation by EasyCell assistant were compared with the results by manual microscopic review and Pentra DX Nexus. The manual microscopic review was performed according to the Clinical and Laboratory Standards Institute guidelines (H20-A2). Results: WBC differentials between pre-classification by EasyCell assistant and manual counting showed moderate correlations for neutrophils (r=0.58), lymphocytes (r=0.69), and eosinophils (r=0.51) in all samples. After user verification, they showed mostly high to very high correlations for neutrophils (r=0.74), lymphocytes (r=0.78), eosinophils (r=0.88), and other cells (r=0.91). PLT count by EasyCell assistant highly correlated with that by Pentra DX Nexus (r=0.82). Conclusions: The performance of EasyCell assistant for WBC differentials and PLT count seems to be acceptable even in abnormal samples with improvement after user verification. The EasyCell assistant, with its reliable performance on WBC differentials and PLT count, would help optimize the workflow of hematology laboratories with reduced workload of manual microscopic review.