The goal of this proposal is to develop a STAT palm-sized blood counter for monitoring complete blood counts (CBC) with 3-part differential during emergencies. Changes in blood counts can reflect acutely worsening medical conditions. For instance, a rapidly rising white blood cell count may occur during infections or a leukemic blast crises. Hematocrit values may rapidly decline in traumas, gastrointestinal bleeds, and post- procedure recoveries. Platelet values may drop significantly during chemotherapy and idiopathic thrombocytopenic purpura. During these situations, close and frequent monitoring of a patient's blood counts is a must to deliver the best care and treatment, whether it be blood transfusions, platelet transfusions, or drug administrations. These clinical scenarios reflect a significant market need. In 2007, $2.7 billion of hematology tests were performed. Of these, an estimated 25-35% of these tests were STAT tests, which are ideally performed at the point-of-care. The proposed blood counter samples a fingerstick of blood from the patient and analyzes it in real-time at the patient's side for point-of-emergency clinical decision making. This is in contrast to today's measurement technologies, which require a benchtop instrument and a trained technician. The central hypothesis for this Phase II SBIR effort is this: microfluidic technology can be utilized to develop an integrated palm-sized blood counter that requires only a pinprick of blood. The proposed 24-month Phase II effort leverages our Phase I accomplishments in microfluidics, sensitive detection, and precision measurements to develop a prototype handheld emergency blood sensor. Advances in detection and microfluidics are required to develop such a device.
Specific Aim 1 will utilize our microfluidics technology to assess serial cell dilution ad red cell lysis.
Specific Aim 2 will be utilized to develop an integrated optical and electrical impedance detection system required for measurement of a wide range of cell parameters.
Specific Aim 3 will be utilized to develop a handheld, breadboard prototype of our STAT blood counter and validate its performance against a gold-standard blood counter across a set of clinical samples. Success in Phase II will lead to a Phase III effort which will include detailed product engineering for a commercial STAT blood counter product, tests for FDA 510(k) approval, and commercialization. The resulting product can be utilized in a wide- range of settings including ambulances, inpatient rooms, operating rooms, medical offices, and resource- starved settings.

Public Health Relevance

This research is relevant to public health because rapid diagnosis of blood counts can be the difference between life and death. The palm-sized blood counter is designed to provide much needed medical information during critical emergencies.

National Institute of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
Application #
Study Section
Special Emphasis Panel (ZRG1-VH-J (10))
Program Officer
Mitchell, Phyllis
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
DNA Medicine Institute
United States
Zip Code