SpinDx™: Point-of-Care Diagnostics Using Centrifugal Microfluidics

Sandia National Laboratories Background
Currently, when a patient arrives at the hospital or doctor’s office feeling ill, they are first examined by the doctor, sent to a blood lab where vials of blood are taken, and then sent home to wait for results. This approach often means patients must wait days or weeks to get results. During that waiting period, they are not receiving treatment, which can be a critical factor for cancer, heart attack, or stroke patients.
Technology Overview
Sandia innovative technique can conduct simultaneous multiplexed immunoassays and white blood cell counts from a single finger prick of whole blood with less than 15 minutes total sample-to-answer time. The technique is based on centrifugal microfluidics, or “lab-on-a-disk’ technology, which uses centrifugal forces to manipulate samples and reagents through microfluidic channels implanted on disks that are of the same size as a standard CD or DVD.
Sandia system engineers are developing a fully-integrated, portable SpinDx™ prototype for user-friendly sample in, answer out functionality. The system uses touchscreen control pad for assay operation and result dissemination. Miniaturized fluorescence optics are used for detection. Samples are self-collected and loaded onto the device using standard capillary collection tubes. Optional wireless data transmission can be added for remote and point-of-care testing applications (, ).

Detection is achieved with a novel bead sedimentation immunoassay scheme. The sample is mixed on-disk with a detection cocktail consisting of a) capture beads coated with antibodies specific for the target(s) of interest, and b) detection antibodies labeled with a fluorescent tag, which will be bound to the capture bead in the presence of the corresponding antigen. Following incubation, the beads are removed from the sample via sedimentation by washing the beads to remove any interferents as the beads stack at the end of the channel. The fluorescent signal of the resulting bead pellet is used to quantify the analyte present. Single channel multiplexing is achieved using beads of different size/density for individual targets.
To obtain blood cell counts, blood samples are mixed on disk with labeling agents (i.e. DNA dyes) to label the leukocytes prior to the centrifugation. The cells then separate along a pre-loaded density media based on their size and density differences. The integrated fluorescent signal of each cell band is used to quantify individual cell population counts.
Further Details:

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Stage of Development
Prototype – Sandia estimates this technology at a Technology Readiness Level (TRL) 6. A prototype has been developed and tested in the laboratory with exogenous animal and human samples.
Benefits
This device can revolutionize the way we get test results from doctor’s offices and hospitals alike. Besides the inherent portability of the testing device, the assay discs can be manufactured for pennies, making this an affordable option for both small and large practices with the potential to drive down the cost of testing, visits, and to shorten time-to-treatment.

Hematology: Leukocyte counts/differentials combined with proteomic detection
Multiplexed immunoassays: up to 64 parallel assays from a single sample
Speed: less than 15 minutes sample-to answer
Minimally-invasive: less than 20µL whole blood input (finger puncture)
Disposable: Inexpensive disk fabrication with pre-loaded reagents for off-the-shelf processing
Simple/robust: Based on well-established principles requiring unsophisticated instrumentation

Applications
Sandia researchers are currently pursuing additional assay concepts to broaden the diagnostic reach of the SpinDx™ platform, including genomics, viral diagnostics, and metabolomics. The integrated on-disk sample prep and extensive multiplexing capabilities facilitate versatile, “multi-omic” screening at the point-of-care, in the field, or at a centralized laboratory.
This technology also has applications beyond medical diagnostics and can be used in food safety testing, bio-terrorism detection, or for drug testing.
Opportunity
This technology is available.
SD#11690
Sandia National Laboratories is a multi-mission laboratory managed and operated by National Technology and Engineering Solutions of Sandia, LLC., a wholly owned subsidary of Honeywell International, Inc., for the U.S. Department of Energy’s National Nuclear Security Administration under contract DE-NA0003525. SAND No 2012-5315844.

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