Rapid Automated Point-of-Care System (RapiDx)

Technology Summary

The Rapid, Automated Point-of-Care System (RapiDx) developed by Sandia National Laboratories is a portable diagnostic instrument. RapiDx quickly measures--with high sensitivity--disease and toxin biomarkers in human biological samples (e.g., blood, saliva, urine) so that patient ailments can be quickly diagnosed and treated. RapiDx is an ideal instrument for point-of-care diagnostics of disease and toxin detection in health clinics and in the field.

Description

Built on Sandia's advancements in lab-on-a-chip technologies, RapiDx is a miniaturized device that requires mere microliters of a sample to measure protein signatures. With RapiDx, drawing tubes of blood is no longer required. Instead, drops of blood or saliva can be collected and analyzed at the point of care (e.g., in a doctor's or dentist's office), thereby enabling low-cost, rapid diagnoses during an office visit. RapiDx can also be used to address bioterrorism threats. If a crowd is exposed to dangerous biotoxins, potentially exposed persons can be triaged rapidly with RapiDx. Timely treatment--critical in such an event--also conserves valuable health resources (e.g., hospital beds, prophylactic supplies).

Publications:

Ariel H. Hecht, Greg J. Sommer, Ross H. Durland, Xianbin Yang, Anup K. Singh, and Anson V. Hatch. (2010, October). "Aptamers as Affinity Reagents in an Integrated Electrophoretic Lab-on-a-Chip Platform." Analytical Chemistry. 82(21), pp 8813-8820. [online]. Available: http://pubs.acs.org/doi/pdf/10.1021/ac101106m

R. J. Meagher, A. V. Hatch, R. F. Renzi, A.K. Singh. (2008). "An integrated microfluidic platform for sensitive and rapid detection of biological toxins." Lab Chip, 8:2046-2053. Available: http://pubs.rsc.org/en/content/articlepdf/2008/lc/b815152k

A. V. Hatch, A. E. Herr, D. J. Throckmorton, J. S. Brennan, A. K. Singh. (2006). "Integrated preconcentration SDS-PAGE of proteins in microchips using photopatterned cross-linked polyacrylamide gels." Analytical Chemistry. 78:4976-4984. Available: http://pubs.acs.org/doi/pdfplus/10.1021/ac0600454

Y-C Wang, A.K. Singh, A.V. Hatch. (2008). "Ultra-rapid sample preconcentration under slant field using high-aspect-ratio nanoporous membranes." Proceedings of MicroTAS 2008, The Twelfth International Conference on Miniaturized Systems for Chemistry and Life Sciences, San Diego, CA. October 12-16. Available: http://www.rsc.org/binaries/LOC/2008/PDFs/Papers/443_0808.pdf

A. E. Herr, A. V. Hatch, D. J. Throckmorton, H. M. Tran, J. S. Brennan, W. V. Giannobile, A.K. Singh. (2007). "Microfluidic immunoassays as rapid saliva-based clinical diagnostics." Proceedings of the National Academy of Sciences of the United States of America 104:5268-5273. Available: http://www.pnas.org/content/104/13/5268.full

Benefits

Microfluidic: Only microliter volumes (e.g., a small droplet of saliva or blood) are required for analysis
Easy sample collection: Designed for use with saliva or a pinprick of blood
Multiplex: A panel of up to 64 analytes can be analyzed simultaneously for accurate assessment
Rapid: A full panel of anlytes can be measured within 10 minutes. Results can be obtained during a routine clinical visit
Sensitive: Low-abundance markers and trace amounts of deadly toxins can be detected by sample peconcentration
Wide, dynamic range: RapiDx is adjustable over several orders of magnitude by timing each preconcentration step
Portable and easy to use: RapiDx offers automated, point-of-care testing with a simple touch-screen interface
Low cost: RapiDx makes widespread screening, diagnosis, and monitoring feasible
Versatile: A variety of diseases, infections, and intoxications can be diagnosed by switching antibody probes

Applications and Industries

Disease detection: RapiDx microfluidic platforms may be used to analyze clinical samples to detect a collegenase enzyme associated with periodontal disease. Unlike the traditional approach--which uses invasive techniques-- RapiDx has the potential to diagnose patients with periodontal disease at the first signs of microscopic bone loss, thereby enabling treatment before significant damage occurs. The highly versatile RapiDx can also be used to detect biomarkers that may be presymptomatic indicators of disease, such as cancer or cardiovascular disease.

Ultrasensitive research tools: The microsystems developed for RapiDx are a step towards fulfilling fundamental needs for highly specific, ultrasensitive, high-throughput, and low-cost analytical tools that will not only improve our understanding of host response to infection and illness, but also aid researchers engaged in drug discovery, biomarker verification, and new strategies for therapy.

 National defense: Troop readiness and field medical diagnosis and treatment are top priorities in national defense. RapiDx allows rapid, simple, and comprehensive diagnostics at low cost at a clinic or in the field. The device also enables quick and effective triaging in the event of intentional crowd exposure to biotoxins, thus improving the outcome for victims and enabling better use of healthcare resources. RapiDx provides direct detection of toxins as well as detection of the signature proteins that are elicited in response to toxin exposure.
SAND 2011-4686W

Intellectual Property

Title
ID Number
Patent Number
Date
Preconcentration and separation of analytes in microchannels 8604.1 7,828,948 11/09/2010
Issued
Portable apparatus for separating sample and detecting target analytes 8412.1 7,452,507 11/18/2008
Issued
Modular optical detector system 8471.0 6,998,598 02/14/2006
Issued
Microfluidic structures and methods for integrating a functional component into a microfluidic device 8419.0 7,351,380 04/01/2008
Issued
Modular high voltage power supply for chemical analysis 8427.2 7,710,086 05/04/2010
Issued
Modular high voltage power supply for chemical analysis 8427.1 7,400,119 07/15/2008
Issued
Modular high voltage power supply for chemical analysis 8427.0 7,161,334 01/09/2007
Issued
Microfluidic device having an immobilized pH gradient and PAGE gels for protein separation and analysis 8,329,016 12/11/2012
Issued
Microfluidic devices and methods including porous polymer monoliths 8,703,058 04/22/2014
Issued
Methods, microfluidic devices, and systems for detection of an active enzymatic agent 8,871,496 10/28/2014
Issued
Method for forming polymerized microfluidic devices 8,047,829 11/01/2011
Issued
Devices, systems, and methods for microscale isoelectric fractionation 9,005,417 04/14/2015
Issued
Microfluidic device having an immobilized pH gradient and page gels for protein separation and analysis 8,728,290 05/20/2014
Issued
Microchannel gel electrophoretic separation systems and methods for preparing and using 8,961,766 02/24/2015
Issued
Method for forming polymerized microfluidic devices 8,394,312 03/12/2013
Issued
Microfluidic devices and methods including porous polymer monoliths 9,201,069 12/01/2015
Issued
Devices, systems, and methods for microscale isoelectric fractionation 9,409,357 08/09/2016
Issued
Technology IDSD# 11152 ;SD # 8604.1; SD# 8427.2; SD# 8412.1; SD# 8419; SD# 8427.1; SD# 8427; SD# 8471; SD# 8508; SD# 11178; SD# 11177; SD# 11282; SD# 10745.1; SD# 11149; SD # 10545.1 Development StagePrototypeAvailabilityAvailablePublished09/29/2011Last Updated08/19/2016