Multicenter study demonstrates 60% faster workflows with accuracy comparable to manual microscopy.

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.

Look inside

“Under clinical study settings, where each examiner reported on a 200‐WBC differential, complete RBC morphology evaluation and platelet estimation based on 10 FOVs, the median time for manual review was 20:00 minutes per case, and the median time for Scopio’s Full-Field PBS review was 7:46 minutes, a 60% improvement of workflow efficiency.”
Ben Zion Katz PhD.,
Director, The Hematology Laboratory Tel Aviv Sourasky Medical Center