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Proceedings Paper

Noninstrumented nucleic acid amplification assay
Author(s): Bernhard H. Weigl; Gonzalo Domingo; Jay Gerlach; Dennis Tang; Darrel Harvey; Nick Talwar; Alex Fichtenholz; Bill van Lew; Paul LaBarre
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Paper Abstract

We have developed components of a diagnostic disposable platform that has the dual purpose of providing molecular diagnostics at the point of care (POC) as well as stabilizing specimens for further analysis via a centralized surveillance system. This diagnostic is targeted for use in low-resource settings by minimally trained health workers. The disposable device does not require any additional instrumentation and will be almost as rapid and simple to use as a lateral flow strip test - yet will offer the sensitivity and specificity of nucleic acid amplification tests (NAATs). The low-cost integrated device is composed of three functional components: (1) a sample-processing subunit that generates clean and stabilized DNA from raw samples containing nucleic acids, (2) a NA amplification subunit, and (3) visual amplicon detection sub-unit. The device integrates chemical exothermic heating, temperature stabilization using phase-change materials, and isothermal nucleic acid amplification. The aim of developing this system is to provide pathogen detection with NAAT-level sensitivity in low-resource settings where there is no access to instrumentation. If a disease occurs, patients would be tested with the disposable in the field. A nucleic acid sample would be preserved within the spent disposable which could be sent to a central laboratory facility for further analysis if needed.

Paper Details

Date Published: 12 February 2008
PDF: 12 pages
Proc. SPIE 6886, Microfluidics, BioMEMS, and Medical Microsystems VI, 688604 (12 February 2008); doi: 10.1117/12.763650
Show Author Affiliations
Bernhard H. Weigl, PATH (United States)
Gonzalo Domingo, PATH (United States)
Jay Gerlach, PATH (United States)
Dennis Tang, PATH (United States)
Darrel Harvey, PATH (United States)
Nick Talwar, PATH (United States)
Alex Fichtenholz, PATH (United States)
Bill van Lew, PATH (United States)
Paul LaBarre, PATH (United States)

Published in SPIE Proceedings Vol. 6886:
Microfluidics, BioMEMS, and Medical Microsystems VI
Wanjun Wang; Claude Vauchier, Editor(s)

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