We propose to develop a Point-of-Care Blood Analyzer that will require ten times smaller blood volumes 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 at UCLA [1] [2] [3] [4]. It relies on lens-free 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 to enable characterization of cells based on texture analysis through digital signal processing. This basic platform, termed Holographic LUCAS, will be developed in this SBIR Phase I project and it will also be expanded to include detection of fluorescent signatures (through Fluorescent LUCAS). Accuracy, sensitivity, specificity, and linearity of both LUCAS platforms will be compared with standard laboratory hematology analyzer using clinical specimens.
Specific aims are to: (1) Demonstrate a prototype Holographic LUCAS platform, (2) Demonstrate a prototype Fluorescent LUCAS platform, (3) Measure diagnostic performance (accuracy, linearity, sensitivity, and specificity) of a Holographic LUCAS RBC, WBC, 3-Part Differential, Hemoglobin, and Platelets, (4) Ditto for a Fluorescent LUCAS for WBC 3-Part Differential. Demonstration of a concept prototype of a unidose cuvette with a pinprick blood intake and very small blood volume of ~1ul is left as the task of a follow-up proposal. (

Public Health Relevance

STATEMENT): 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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
6R43EB011427-02
Application #
8408849
Study Section
Special Emphasis Panel (ZEB1-OSR-B (J1))
Program Officer
Korte, Brenda
Project Start
2011-05-01
Project End
2013-04-30
Budget Start
2012-02-01
Budget End
2012-04-30
Support Year
2
Fiscal Year
2011
Total Cost
$125,397
Indirect Cost
Name
Holomic, LLC
Department
Type
DUNS #
078274262
City
Palm Harbor
State
FL
Country
United States
Zip Code
34684