We propose to develop a Point-of-Care Blood Analyzer that will require ten times smaller blood volume or less and it will provide instant results to improve health of children in health disparity populations. The analyzer would be used for monitoring of anemia in children;neutropenia in children;evaluation for infections (total white count, increased white blood cells with neutrophil predominance, as an inflammatory marker);screening newborns for anemia, high WBC or neutropenia, with the use of very low blood volumes;clinical trial use in patients from diverse populations and ages. Morbidity and mortality are disproportionally high in children under five years of age particularly in resource poor or disenfranchised populations including those in urban and rural areas in the United States. The major issues affecting infants and young children is infection followed by anemia and poor nutrition. A complete blood count is commonly used for diagnosis and the proposed analyzer will be the first to measure RBC, WBC, 3-part differential, hemoglobin, and platelets at the point-of-care. The underlying technology of this transformative imaging platform was demonstrated by Prof. Ozcan's Group at UCLA [1 to 13]. It relies on innovative lensfree holographic imaging of cells, bacteria or other micro-scale particles on a low-cost cell phone camera chip at unprecedented throughputs. The holographic diffraction patterns of various blood cells are quite rich in information to enable characterization of cells based on shape and texture analysis through digital signal processing. This basic platform, termed Holographic LUCAS, will be developed in this SBIR Phase I project. Accuracy, precision, and linearity of the LUCAS platform will be compared with standard laboratory hematology analyzer using unidentified blood specimens.
Specific aims are to: (1) Develop an experimental platform consisting of a prototype Holographic CBC Analyzer and a lab cuvette design suitable for use as a sample holder in Phase I. (2) Research imaging of WBC 3-part differential (granulocytes, monocytes, and lymphocytes) with a holographic LUCAS imager and demonstrate accurate counting;(3) Develop a manual sample preparation process to be used with lab cuvettes for sample preparation in Phase I. The process is the first step in the development of an automated unidose cuvette in Phase II. (4) The final aim of this research will be to measure analyzer performance for RBC, WBC, 3-Part Differential, Hemoglobin, and Platelets. Preliminary tests will be done with purchased blood from the blood bank and final tests with unidentified specimens from UCI clinical laboratory. At least 100 samples will be measured to achieve desired statistical confidence. The results will be compared with the gold standard laboratory hematology analyzer (such as Beckman Coulter LH 750) and with manual microscopy. After commercialization this analyzer will dramatically lower the cost and barriers to use as a point-of-care diagnostic instrument for health disparity populations and also for general use in the US, the developed world, and resource-limited countries. Future applications include CBC, Malaria, TB, HIV, and others.

Public Health Relevance

We propose a new technological platform that will enable CBC blood analysis for children in health disparity populations using a compact, light-weight and cost-effective unit that can be operated by minimally trained personnel right at the point of care or in resource poor settings such as rural areas. This proposed platform will enable effective monitoring of anemia in children;neutropenia in children;assist in the evaluation for infections;screen newborns for anemia, neutropenia or infections with the use of very low blood volumes.

National Institute of Health (NIH)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZEB1-OSR-B (J1))
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Korte, Brenda
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Holomic, LLC
Palm Harbor
United States
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