03019nas a2200313 4500008004100000022001400041245015500055210006900210260000900279300001100288490000600299520199700305653002502302653001602327653002002343653003602363653004202399653002602441653002402467100001802491700002402509700001702533700001902550700001902569700002102588700001702609700002002626856005902646 2011 eng d a1932-620300aA simple, inexpensive device for nucleic acid amplification without electricity-toward instrument-free molecular diagnostics in low-resource settings.0 asimple inexpensive device for nucleic acid amplification without c2011 ae197380 v63 a

BACKGROUND: Molecular assays targeted to nucleic acid (NA) markers are becoming increasingly important to medical diagnostics. However, these are typically confined to wealthy, developed countries; or, to the national reference laboratories of developing-world countries. There are many infectious diseases that are endemic in low-resource settings (LRS) where the lack of simple, instrument-free, NA diagnostic tests is a critical barrier to timely treatment. One of the primary barriers to the practicality and availability of NA assays in LRS has been the complexity and power requirements of polymerase chain reaction (PCR) instrumentation (another is sample preparation).

METHODOLOGY/PRINCIPAL FINDINGS: In this article, we investigate the hypothesis that an electricity-free heater based on exothermic chemical reactions and engineered phase change materials can successfully incubate isothermal NA amplification assays. We assess the heater's equivalence to commercially available PCR instruments through the characterization of the temperature profiles produced, and a minimal method comparison. Versions of the prototype for several different isothermal techniques are presented.

CONCLUSIONS/SIGNIFICANCE: We demonstrate that an electricity-free heater based on exothermic chemical reactions and engineered phase change materials can successfully incubate isothermal NA amplification assays, and that the results of those assays are not significantly different from ones incubated in parallel in commercially available PCR instruments. These results clearly suggest the potential of the non-instrumented nucleic acid amplification (NINA) heater for molecular diagnostics in LRS. When combined with other innovations in development that eliminate power requirements for sample preparation, cold reagent storage, and readout, the NINA heater will comprise part of a kit that should enable electricity-free NA testing for many important analytes.

10aDeveloping Countries10aElectricity10aHot Temperature10aMolecular Diagnostic Techniques10aNucleic Acid Amplification Techniques10aPlasmodium falciparum10aReference Standards1 aLaBarre, Paul1 aHawkins, Kenneth, R1 aGerlach, Jay1 aWilmoth, Jared1 aBeddoe, Andrew1 aSingleton, Jered1 aBoyle, David1 aWeigl, Bernhard uhttp://www.microfluidicsciences.com/drupal/?q=node/209