An artificial intelligence-assisted diagnostic platform for rapid near-patient hematology

Abstract

Hematology analyzers capable of performing complete blood count (CBC) have lagged in their prevalence at the point-of-care. Sight OLO (Sight Diagnostics, Israel) is a novel hematological platform which provides a 19-parameter, five-part differential CBC, and is designed to address the limitations in current point-of-care hematology analyzers using recent advances in artificial intelligence (AI) and computer vision. Accuracy, repeatability, and flagging capabilities of OLO were compared with the Sysmex XN-Series System (Sysmex, Japan). Matrix studies compared performance using venous, capillary and direct-from-fingerprick blood samples. Regression analysis shows strong concordance between OLO and the Sysmex XN, demonstrating that OLO performs with high accuracy for all CBC parameters. High repeatability and reproducibility were demonstrated for most of the testing parameters. The analytical performance of the OLO hematology analyzer was validated in a multicenter clinical laboratory setting, demonstrating its accuracy and comparability to clinical laboratory-based hematology analyzers. Furthermore, the study demonstrated the validity of CBC analysis of samples collected directly from fingerpricks.

FIGURE 1

The Sight OLO hematology analyzer. (A) A rendering of the Sight OLO hematology analyzer (Sight Diagnostics, Israel), a desktop system measuring 284 mm × 255 mm × 324 mm. (B) Components of OLO's single‐use test kit: (1) cartridge, (2) mixing‐bottle, (3) dropper‐cap, (4) microcapillary. (C) Sample preparation workflow for fingerprick samples. (D,E) False‐colored micrographs collected using OLO's multispectral microscopy. Red channel: hemoglobin absorption; green channel: nuclear DNA fluorescence; blue channel: cytoplasmic staining. (D) Characteristic examples of different white blood cell types. (E) Characteristic examples of different anomalous cell types and formations [Color figure can be viewed at wileyonlinelibrary.com]

FIGURE 2

Results of the method comparison study between the Sight OLO and the Sysmex XN hematology analyzers. Graphs indicate Pearson correlation, slope and bias for each parameter. These results are tabulated in Table S1 [Color figure can be viewed at wileyonlinelibrary.com]