Investigations were conducted into the clinical performance of DI-60 in RBC, WBC, and hands-on time analysis. Following CLSI H20-A2, two (2) medical technologists conducted differential counts via PBS and examined the blood smear under a light microscope for the manual slide review.

The accuracy assessment of the RBC morphology determined by DI-60 in comparison to the manual PBS review and the assessment of the repeatability and within laboratory precision of the percentage values generated from DI-60 for the RBC morphology of PBSs from 20 abnormal samples were included in the performance evaluation of RBC analysis. The mean corpuscular hemoglobin concentration, red cell distribution width, and mean corpuscular volume from XN-20 were compared with those from DI-60 to examine the parameters of RBCs with hypochromasia, anisocytosis, microcytosis, and macrocytosis—rather than using manual slide review.

Performance evaluation for WBC analysis included comparing WBC and non-WBC differential counts between pre-classification by DI-60 and after-user verification, analyzing the association between verified DI-60 WBC differential counts and manual differential counts, evaluating the agreement between DI-60 results and the flags generated from the hematology analyzer (XN-20) for abnormal cell identification, and assessing the precision of recognizing abnormal cells and blasts between DI-60 and manual review.

A complete analysis of the hands-on and assay times was carried out utilizing 10 normal and 10 abnormal specimens. Two skilled medical technicians who did not use the DI-60 equipment manually reviewed 200 WBC differential counts, and the overall assay time was recorded five times per slide for DI-60.