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-finger-prick 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.
One Sentence Summary We present a novel diagnostic platform based on artificial intelligence-assisted image analysis that is capable of performing rapid complete blood count from venous, capillary, and finger-prick samples in near-patient settings.
Competing Interest Statement
Employment or Leadership: Y. Eshel, S.D. Sight Diagnostics LTD; D. Levner, S.D. Sight Diagnostics LTD; A. Zait, S.D. Sight Diagnostics LTD; D. Glück, S.D. Sight Diagnostics LTD; D. Benbassat, S.D. Sight Diagnostics LTD; S. Pecker, S.D. Sight Diagnostics LTD; D. Brailovsky, S.D. Sight Diagnostics LTD; E. Yurkovsky, S.D. Sight Diagnostics LTD; N. Bachar, S.D. Sight Diagnostics LTD; S. Levy, S.D. Sight Diagnostics LTD. Consultant or Advisory Role: None declared Stock Ownership: Y. Eshel, D. Levner, A. Zait, D. Glück, D. Benbassat, S. Pecker, D. Brailovsky, E. Yurkovsky, N. Bachar, and S. Levy have ownership of S.D. Sight Diagnostics LTD stocks or stock options. Honoraria: None Declared Expert Testimony: None declared Patents: Y. Eshel, D. Levner, A. Zait, D. Glück, D. Benbassat, S. Pecker, D. Brailovsky, and S. Levy are inventors of patent applications and issued patents assigned to S.D. Sight Diagnostics LTD (PCT/IL2017/050526; PCT/IL2017/050523; PCT/IB2020/061728; PCT/IB2020/061724; PCT/IL2016/051025; PCT/IB2020/061732; PCT/IB2020/061736 PCT/IB2020/061731; PCT/IB2020/059924). Other remunerations: None declared
Clinical Trial
NCT03595501
Funding Statement
The funding organization played a direct role in study design, data review and interpretation, manuscript preparation, and manuscript final approval
Author Declarations
I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
Boston Children's Hospital Institutional Review Board, Boston, MA, USA Presbyterian Healthcare Services Human Research Protections and Institutional Review Board, Albuquerque, NM, USA Columbia University Human Research Protection Office Institutional Review Boards, New York, NY, USA Tel Aviv Sourasky Medical Center Ethics Comittee, Tel Aviv, Israel
All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
Yes
I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.
Yes
Data Availability
Data and analysis code is available on request from the authors and will be shared under a MTA.