Method of analysing the nucleic acid content of biological fluid

Abstract

A method of analyzing the nucleic acid content of a biological fluid, the method comprising the steps of: providing a test module with an outer casing configured for handheld portability, the outer casing having a receptacle for receiving the biological fluid, the test module having a hybridization section with an array of probes for hybridization with target nucleic acid sequences in the biological fluid, and circuitry for sensing which of the probes have hybridized and generating hybridization data, providing a test module reader for reading the hybridization data from the test module, inserting the biological fluid in the receptacle, interfacing the test module with the test module reader, wherein, the test module reader analyses the nucleic acid content from the hybridization data.

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

[0104]The easily usable, mass-producible, and inexpensive LOC device for analysis of nucleic acid content of biological fluid samples accepts a biological fluid sample through its sample receptacle, lyses the sample's cells in its lysis chamber to release the sample's genetic material, amplifies target genetic sequences, and analyzes the sample's nucleic acid sequences via hybridization with oligonucleotide probes with sensing via its integral imaging array.

[0105]The lysing process extracts the genetic material from cells in the sample and provides for follow-on processing and analysis of the targets. The lysis subunit being integral to the device, provides for simple assay procedures, low system component-count, and simple system manufacturing procedures, leading into an inexpensive assay system.

[0106]The amplification of target genetic sequences increases the sensitivity and signal-to-noise ratio of the assay system.

[0107]The probe hybridization section provides for analysis of the targets via hybridization. The integrated probe hybridization section provides for an easily usable, mass-producible, and inexpensive integrated solution with low system component-count.

[0108]The integrated image sensor obviates the need for an expensive external imaging system and provides for a mass-producible inexpensive integrated solution with low system component-count that is a compact, light, and highly portable system. The integrated image sensor increases the readout sensitivity by benefiting from large angle of light collection and obviates the need for optical components in the optical collection train.

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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