Rapid, high-throughput, and highly accurate identification of potential blood borne diseases will help blood banks to quickly test a very large volume of donated blood, and will help to prevent further infections. Current blood testing has the following issues: 1. Time consuming testing and sample operation that must be performed for all diseases "one-by-one". 2. A large sample volume is required that depends on the number of tests. 3. Testing procedure is complicated as the number of tests increase. 4. Complicated operational procedures that must be run by highly trained personnel in molecular laboratories. The recent development of commercially-available assays using nucleic acid amplification test technologies (NAT) have made it possible for blood centers to consider applying these tests to blood donor screening. But NAT test systems, so far, are time intensive, not in "multiplexed (>2) fashion", thus are unsuited to large-scale screening of donor samples for various pathogens. Maxwell Sensors, Inc. (MSI) proposes to combine Helicase-Dependent Amplification and Barcode Magnetic Bead (BMB) technologies to produce a rapid, Simultaneous Assay for Multiple Pathogens in Blood (SAMP-B). With a few drops of a donor's blood combined with digital magnetic beads in a single microwell, it is possible to simultaneously identify HIV type 1 and 2, Hepatitis B (HBV), Syphilis, Hepatitis C (HCV), Human T-Lymphotropic Virus (HTLV type I and II), West Nile Virus (WNV), and many other blood-borne diseases. During this Phase I project, we have completed all tasks and successfully demonstrated the technical feasibility of simultaneous assay for multiple pathogens by fabricating 128-plex BMBs, integrating the analyzer, and performing HIV, HBV, and Syphilis multiplexed assays. The resulting combined technology is very powerful and will offer the following advantages: (1) Small quantity of sample: a few drops of blood in a microwell are all that's needed to identify multiple target pathogens. It not only determines a reactive sample, but also identifies "reactive to what" (2) Reduced window period: offers high sensitivity and specificity without the "window period" associated with antibody based screening technologies (3) Rapid and high throughput: the system can automatically process up to 100 samples per hour - for a maximum of 12,800 reportable results in a 96-microwell format (4) Flexibility: easy addition of new probes for additional screening targets on beads (5) Low cost, easy to use, and high reliability: BMB are low cost, simple operation steps, and batch to batch variation is minimal. In this Phase II project, we will focus on: (1) expand blood-borne pathogens panels from (3-plex to 8-plex) for Blood screening, (2) integrate the sample process with SAMP-B analyzer, and (3) develop and evaluate multiplex pathogens for blood screening.

Public Health Relevance

Maxwell Sensors Inc. (MSI) proposes to develop a helicase-dependent amplification-based system, using digital magnetic bar-coded beads that provide rapid, accurate, and easy-to-use screening for multiple bloodborne pathogens in small specimens of donor blood. This Simultaneous Assay for Multiple Pathogens in Blood will help blood banks and clinical laboratories to quickly test very large volumes of donated blood, and will help prevent the spread of blood-borne infections. The proposed technology that marries an advanced semiconductor fabrication process with molecular signature amplification will allow high-throughput molecular diagnostic profiling of individuals at relatively low cost.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HL097406-02
Application #
8315698
Study Section
Special Emphasis Panel (ZRG1-IDM-V (12))
Program Officer
Mitchell, Phyllis
Project Start
2009-08-03
Project End
2014-06-30
Budget Start
2012-08-01
Budget End
2013-06-30
Support Year
2
Fiscal Year
2012
Total Cost
$497,892
Indirect Cost
Name
Maxwell Sensors, Inc.
Department
Type
DUNS #
128956534
City
Santa Fe Springs
State
CA
Country
United States
Zip Code
90670