Loc device with dialysis section for separating leukocytes and pathogens from blood

Abstract

A lab-on-a-chip (LOC) device to separate pathogens and leukocytes from a blood sample for analysis, the LOC device having a sample inlet for receiving the blood including pathogens, leukocytes and other constituents, a dialysis section for separating the pathogens into a first portion of the sample and separating the leukocytes into a second portion of the sample such that the remainder of the sample has constituents smaller than the leukocytes and larger than the pathogens, and, a microsystems technology (MST) layer for analyzing the pathogens and the leukocytes.

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

[0088]The easily usable, mass-producible, and inexpensive LOC device accepts a blood sample, uses a dialysis section for separating the leukocytes and pathogens from the sample, and separately processes the nucleic acid content of the leukocytes and pathogens separated from the blood sample.

[0089]The dialysis section functionality extracts additional information from the blood sample and increases the sensitivity, signal-to-noise ratio, and dynamic range of the assay system. The dialysis system being integral to the device, provides 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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