Clinical evaluation of a fully electronic microfluidic white blood cell analyzer.

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  • Additional Information
    • Source:
      Publisher: Public Library of Science Country of Publication: United States NLM ID: 101285081 Publication Model: eCollection Cited Medium: Internet ISSN: 1932-6203 (Electronic) Linking ISSN: 19326203 NLM ISO Abbreviation: PLoS One Subsets: MEDLINE
    • Publication Information:
      Original Publication: San Francisco, CA : Public Library of Science
    • Subject Terms:
      Microfluidics* ; Hematology*/methods; Adult ; Humans ; Leukocyte Count ; Leukocytes ; Blood Cell Count
    • 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.
      Competing Interests: M.J., J.S., S.A., F.S., and Z.L. are equity holders of RizLab Health. M.J., J.S., S.A., and Z.L. are inventors of patents for CytoTracker technology. The CytoTracker is currently undergoing product development at RizLab Health and has not yet obtained regulatory clearance and is for research use only. The issued patent related to the paper is US11506592B2 (Wearable impedance cytometer) and a pending patent related to the paper is WO2023086733A3 (Microfluidic cartridges and methods of use thereof). This does not alter our adherence to PLOS ONE policies on sharing data and materials.
      (Copyright: © 2024 Sui et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
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    • Publication Date:
      Date Created: 20240118 Date Completed: 20240122 Latest Revision: 20240122
    • Publication Date:
      20240122
    • Accession Number:
      PMC10796056
    • Accession Number:
      10.1371/journal.pone.0296344
    • Accession Number:
      38236796