Clinical evaluation of a fully electronic microfluidic white blood cell analyzer

PLoS One. 2024 Jan 18;19(1):e0296344. doi: 10.1371/journal.pone.0296344. eCollection 2024.

Abstract

The White Blood Cell (WBC) count is one of the key parameters signaling the health of the immune system. Abnormal WBC counts often signal a systemic insult to the body such as an underlying infection or an adverse side effect to medication. Typically, the blood collected is sent to a central lab for testing, and results come back within hours, which is often inconvenient and may delay time-sensitive diagnosis or treatment. Here, we present the CytoTracker, a fully electronic, microfluidic based instant WBC analyzer with the potential to be used at point-of-care. The CytoTracker is a lightweight, portable, affordable platform capable of quantifying WBCs within minutes using only 50 μl of blood (approximately one drop of blood). In this study, we clinically evaluated the accuracy and performance of CytoTracker in measuring WBC and granulocyte counts. A total of 210 adult patients were recruited in the study. We validated the CytoTracker against a standard benchtop analyzer (Horiba Point of Care Hematology Analyzer, ABX Micros 60). Linear dynamic ranges of 2.5 k/μl- 35 k/μl and 0.6 k/μl- 26 k/μl were achieved for total WBC count and granulocyte count with correlation coefficients of 0.97 and 0.98. In addition, we verified CytoTracker's capability of identifying abnormal blood counts with above 90% sensitivity and specificity. The promising results of this clinical validation study demonstrate the potential for the use of the CytoTracker as a reliable and accurate point-of-care WBC analyzer.

MeSH terms

  • Adult
  • Blood Cell Count
  • Hematology* / methods
  • Humans
  • Leukocyte Count
  • Leukocytes
  • Microfluidics*

Grants and funding

This work was funded in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority DRIVe (Division of Research, Innovation, and Ventures) Early Notification to Act, Control, and Treat (ENACT) under contract No. 75A50119C00048 and the National Science Foundation Small Business Innovation Research Grant number 2025773. The research is also funded by RizLab Health, Inc. M.J., J.S., S.A., F.S., and Z.L. have financial interests in RizLab Health. National Science Foundation Small Business Innovation Research: M.J., J.S., and Z.L. #2025773 https://seedfund.nsf.gov/ This sponsor played no role in the study design, data collection and analysis, publication decision, and manuscript preparation. The U.S. Department of Health and Human Services | Biomedical Advanced Research and Development Authority (BARDA): M.J., J.S., and Z.L. Contract #75A50119C00048 https://aspr.hhs.gov/AboutASPR/ProgramOffices/BARDA/Pages/default.aspx This sponsor played no role in the study design, data collection and analysis, publication decision, and manuscript preparation. The research is also funded by RizLab Health, Inc. The team members associated with RizLab Health played a role in the study design, data collection and analysis, publication decision, and manuscript preparation. T.B., Z.R. https://www.rizlabhealth.com/.