Evaluation of Scopio Labs X100 Full Field PBS: The first high‐resolution full field viewing of peripheral blood specimens combined with artificial intelligence‐based morphological analysis

Abstract

Background Current digital cell imaging systems perform peripheral blood smear (PBS) analysis in limited regions of the PBS and require the support of manual microscopy without achieving full digital microscopy. We report a multicenter study that validated the Scopio Labs X100 Full Field PBS, a novel digital imaging system that utilizes a full field view approach for cell recognition and classification, in a decision support system mode. Methods We analyzed 335 normal and 310 abnormal PBS from patients with various clinical conditions and compared the performance of Scopio's Full Field PBS as the test method, with manual PBS analysis as the reference method. Deming regression analysis was utilized for comparisons of WBC and platelet estimates. Measurements of WBC and platelet estimation accuracy along with the agreement on RBC morphology evaluation were performed. Reproducibility and repeatability (R&R) of the system were also evaluated. Results Scopio's Full Field PBS WBC accuracy was evaluated with an efficiency of 96.29%, sensitivity of 87.86%, and specificity of 97.62%. The agreement between the test and reference method for RBC morphology reached 99.77%, and the accuracy for platelet estimation resulted in an efficiency of 94.89%, sensitivity of 90.00%, and specificity of 96.28%, with successful R&R tests. The system enabled a comprehensive review of full field PBS as shown in representative samples. Conclusions Scopio's Full Field PBS showed a high degree of correlation of all tested parameters with manual microscopy. The novel full field view of specimens facilitates the long‐expected disengagement between the digital application and the manual microscope.

How Reproducible Is the Data from Sysmex DI-60 in Leukopenic Samples?

“…Last, although we evaluated within-laboratory precision, we could not evaluate interlaboratory precision. Evaluation of interlaboratory precision is important to ensure reliable and comparable results between DM analyzers performed at different laboratories [ 33 , 36 ]. A standardized approach and protocol are also necessary for evaluating precision of WBC differentials in both DM analyzers and manual count [ 4 , 21 ].…”

Integrating artificial intelligence into haematology training and practice: Opportunities, threats and proposed solutions

“…7 A recent study reported on the use of a novel AI-based decision support system that utilised a full-field approach for blood cell recognition and classification in both normal and abnormal peripheral blood films. 8 Impressive degrees of correlation with conventional manual microscopy were achieved. Such systems will not replace morphologists but act as a labourassistance device to alleviate busy workloads.…”

“…It has been estimated that some 15% of blood samples require manual review 7 . A recent study reported on the use of a novel AI‐based decision support system that utilised a full‐field approach for blood cell recognition and classification in both normal and abnormal peripheral blood films 8 . Impressive degrees of correlation with conventional manual microscopy were achieved.…”

Remote Digital Microscopy Improves Hematology Laboratory Workflow by Reducing Peripheral Blood Smear Analysis Turnaround Time

“…In October of 2020, the U.S. Food and Drugs Administration (FDA) cleared Scopio Labs' X100 Full-Field PBS system. A digital PBS morphological analyzer with full field specimen view, which offers fully digital and remote option for PBSs evaluation, interpretation and review 6 . As previously reported by Katz et al 6 , the Scopio Labs X100 Full-Field PBS system has demonstrated that, under clinical study settings where each examiner reported a 200white blood cell (WBC) differential, complete red blood cell (RBC) morphology evaluation and platelet estimation, the median time for PBS review was 7:46 minutes, a 60% improvement of workflow efficiency, when compared to a manual PBS review of 20.0 minutes per case 6 .…”

“…PBS examination by manual microscopy remains one of the most time consuming and laborintensive procedures in the laboratory, requiring specialized staff, which negatively impacts TAT, particularly during weekends with limited staff availability 2,3 . The increased demand for hematological morphology tests such as the PBS with clearly defined TATs, the complexity of PBS analysis, and the speed of diagnosis to enable immediate clinical action, coupled with the shortage of skilled morphologists and increasing pressure for cost containment, is driving digitalization of microscopy and remote review to the forefront of laboratory workflow management 2,4,6,7,8 .…”