Microfluidic device with PCR section and diffusion mixer

Abstract

A microfluidic device having a sample inlet for receiving a sample of biological material having nucleic acid sequences, a polymerase chain reaction (PCR) section for amplifying the nucleic acid sequences, a reagent reservoir containing a reagent, and, a diffusion mixing section for mixing the nucleic acid sequences with the reagent, the diffusion mixing section having a microchannel defining a tortuous flow-path having a length sufficient for diffusive mixing of the reagent and the sample, wherein during use, the sample flows from the sample inlet to the PCR section via the diffusion mixing section.

Description

FIELD OF THE INVENTION[0001]The present invention relates to diagnostic devices that use microsystems technologies (MST). In particular, the invention relates to microfluidic and biochemical processing and analysis for molecular diagnostics.CO-PENDING APPLICATIONS[0002]The following applications have been filed by the Applicant which relate to the present application:GBS001USGBS002USGBS003USGBS005USGBS006USGSR001USGSR002USGAS001USGAS002USGAS003USGAS004USGAS006USGAS007USGAS008USGAS009USGAS010USGAS012USGAS013USGAS014USGAS015USGAS016USGAS017USGAS018USGAS019USGAS020USGAS021USGAS022USGAS023USGAS024USGAS025USGAS026USGAS027USGAS028USGAS030USGAS031USGAS032USGAS033USGAS034USGAS035USGAS036USGAS037USGAS038USGAS039USGAS040USGAS041USGAS042USGAS043USGAS044USGAS045USGAS046USGAS047USGAS048USGAS049USGAS050USGAS054USGAS055USGAS056USGAS057USGAS058USGAS059USGAS060USGAS061USGAS062USGAS063USGAS065USGAS066USGAS067USGAS068USGAS069USGAS070USGAS080USGAS081USGAS082USGAS083USGAS084USGAS085USGAS086USGAS087USGAS...

AI Technical Summary

Benefits of technology

[0079]The mass-producible and inexpensive microfluidic device accepts a liquid for processing and / or analysis, with the requisite fluidic propulsion being provided via capillary action, and the requisite valve functionality being provided via reliable, easily manufacturable thermal bend actuated pressure pulse valves. The thermal bend actuated pressure pulse valves exploit the intrinsic positive qualities of microfluidic device technologies and avoid problematic aspects of such technologies.

[0307]The microfluidic PCR chamber is an easily manufacturable PCR cycler and is integral to the device, in turn providing for an easily assembled and inexpensive microfluidic system with a low component-count.

Problems solved by technology

Insufficient stringency can result in a high degree of nonspecific binding.

Excessive stringency can lead to a failure of appropriate binding, which results in diminished sensitivity.

Despite the advantages that molecular diagnostic tests offer, the growth of this type of testing in the clinical laboratory has been slower than expected and remains a minor part of the practice of laboratory medicine.

This is primarily due to the complexity and costs associated with nucleic acid testing compared with tests based on methods not involving nucleic acids.

However, controlling fluid flow through the LOC device, adding reagents, controlling reaction conditions and so on necessitate bulky external plumbing and electronics.

Connecting a LOC device to these external devices effectively restricts the use of LOC devices for molecular diagnostics to the laboratory setting.

The cost of the external equipment and complexity of its operation precludes LOC-based molecular diagnostics as a practical option for point-of-care settings.

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