System for variable loading of reagents into microfluidic device for genetic analysis

Abstract

A system for loading reagents into a microfluidic device for genetic analysis, the system having containers with reagents for processing a biological sample in the microfluidic device, an integrated circuit secured to each of the containers respectively, each of the integrated circuits having a container digital memory storing reagent specification data related to the reagent in that container, a microfluidic device for performing a desired genetic test assay, the microfluidic device having a device digital memory, a reagent dispensing apparatus for loading a selection of the reagents into the microfluidic device, the reagent dispensing apparatus having a control microprocessor for accessing the container digital memory and transmitting the specification data to the device digital memory, and, a device reader for accessing the reagent specification data from the device digital memory in order to analyze test assay results from the microfluidic device.

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

"The present invention provides a system for loading reagents into a microfluidic device for genetic analysis. The system includes containers with reagents, an integrated circuit with a digital memory storing reagent specification data, a reagent dispensing apparatus for loading the reagents into the microfluidic device, and a device reader for accessing the reagent specification data. The microfluidic device has a supporting substrate, a microsystems technologies (MST) layer for supporting an array of oligonucleotide probes, and CMOS circuitry between the MST layer and the supporting substrate, the CMOS circuitry having a photosensor for detecting hybridization within the probes. The system also has a test module in which the microfluidic device is mounted, a receptacle for receiving the biological sample containing the target nucleic acid sequences, and a droplet generator for ejecting droplets of the reagent into the reagent reservoirs. The data stored in the container digital memory and the device digital memory is encrypted. The system provides automated, fast, easy, and low-cost compilation of easy-to-use and inexpensive application-specific / application-optimized assay systems."

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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