Loc device with dialysis section for removing erythrocytes from blood

Abstract

A lab-on-a-chip (LOC) device for analyzing leukocytes in a blood sample, the LOC device having a supporting substrate, an inlet for receiving a sample of blood, a dialysis section for separating erythrocytes from leukocytes in the blood, and, a microsystems technology (MST) layer for analyzing the leukocytes, wherein, the inlet, the dialysis section and the MST layer are all supported on the supporting substrate.

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:GBS001USGBS002USGBS003USGBS005USGBS006USGSR001USGSR002US GAS001USGAS002USGAS003USGAS004US GAS006USGAS007US GAS008USGAS009US GAS010USGAS012US GAS013USGAS014US GAS015USGAS016US GAS017USGAS018US GAS019USGAS020US GAS021USGAS022USGAS023USGAS024USGAS025USGAS026US GAS027USGAS028US GAS030USGAS031USGAS032USGAS033US GAS034USGAS035US GAS036USGAS037US GAS038USGAS039US GAS040USGAS041USGAS042USGAS043USGAS044USGAS045USGAS046USGAS047US GAS048USGAS049US GAS050USGAS054US GAS055USGAS056US GAS057USGAS058US GAS059USGAS060US GAS061USGAS062US GAS063USGAS065US GAS066USGAS067US GAS068USGAS069US GAS070USGAS080US GAS081USGAS082US GAS083USGAS084US...

AI Technical Summary

Benefits of technology

[0091]The easily usable, mass-producible, and inexpensive LOC device accepts a blood sample, adds an erythrocyte lysis buffer from a reagent reservoir to lyse erythrocytes, uses a dialysis section for separating the leukocytes from the lysed erythrocytes, and separately processes the nucleic acid content of the leukocytes separated from the blood sample.

[0092]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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