Test module with parallel nucleic acid amplification sections

Abstract

A test module for amplifying nucleic acid sequences, the test module having an outer casing with receptacle for receiving a sample containing genetic material, a plurality of reagent reservoirs containing reagents for addition to the sample, a first nucleic acid amplification section for amplifying nucleic acid sequences in the genetic material, and, a second nucleic acid amplification section for amplifying nucleic acid sequences in the genetic material in parallel with the first nucleic acid amplification 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

[0101]The easily usable, mass-producible, inexpensive, and portable test-module accepts a sample containing nucleic acids and then using the module's parallel nucleic acid amplification section amplifies the nucleic acid targets in the sample, utilizing reagents stored in the test-module's reagent reservoirs.

[0102]The nucleic acid amplification section provides for capillary action propulsion of the amplification mixture, simplifying the design of the assay system, further increasing the reliability and reducing the cost of the assay system. The amplification of target nucleic acid sequences increases the sensitivity and signal-to-noise ratio of the assay system. Furthermore, the parallel amplification chambers allow separate targets or target groups to optimally use separate primer pairs or separate groups of primer pairs and also to use separate optimal amplification parameters, with the consequent increase in assay sensitivity, signal-to-noise-ratio, and reliability.

[0103]The reagent reservoirs, being integral to the test-module and holding the assay's total reagent requirements, provide for the low system component-count and simple manufacturing procedures, leading into an inexpensive assay system.

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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