Single-use test module for detection of hybridization of targets with oligonucleotide probes

Abstract

A single-use test module having an outer casing dimensioned for hand-held portability, the outer casing having an inlet for receiving a biological sample containing a target nucleic acid sequence, probes in the outer casing for hybridization having a nucleic acid sequence for hybridization with a target nucleic acid sequence to form a probe-target hybrid, the probe-target hybrid being configured to generate a fluorescence signal in response to an excitation light, and, a photosensor to detect the fluorescence signal.

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:GBS001USGBS002USGBS003USGBS005USGBS006USGSR001USGSR002USGAS001USGAS002USGAS003USGAS004USGAS006USGAS007USGAS008USGAS009USGAS010USGAS012USGAS013USGAS014USGAS015USGAS016USGAS017USGAS018USGAS019USGAS020USGAS021USGAS022USGAS023USGAS024USGAS025USGAS026USGAS027USGAS028USGAS030USGAS031USGAS032USGAS033USGAS034USGAS035USGAS036USGAS037USGAS038USGAS039USGAS040USGAS041USGAS042USGAS043USGAS044USGAS045USGAS046USGAS047USGAS048USGAS049USGAS050USGAS054USGAS055USGAS056USGAS057USGAS058USGAS059USGAS060USGAS062USGAS063USGAS065USGAS066USGAS067USGAS068USGAS069USGAS070USGAS080USGAS081USGAS082USGAS083USGAS084USGAS085USGAS086USGAS087USGAS088USGAS...

AI Technical Summary

Benefits of technology

[0086]Preferably, the FRET probes have a quencher suppress the fluorescence signal from the fluorophore when the probe is in a non-hybridized configuration, the quencher having no native emission in response to the excitation light.

[0088]The easily usable, mass-producible, inexpensive, compact, and light genetic test module accepts a biological sample, identifies the sample's nucleic acid sequences via probe hybridization using its integral image sensor, and provides the results electronically at its output port.

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.

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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