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A Microfluidics Device for Diagnostic Testing

IP.com Disclosure Number: IPCOM000241501D
Publication Date: 2015-May-07

Publishing Venue

The IP.com Prior Art Database

Abstract

This invention describes a novel device which is able to perform multiple analyses from a single biological sample through the application of microfluidics with cellulose technologies. The analytes that can be detected include but are not limited to DNA, RNA and protein. The device can be configured to detect different molecules derived from a single class of analyte or configured to detect a range of different analytes e.g. DNA, RNA and protein from a single applied biological sample. The use of differently labelled detection reagents e.g. antibodies, oligonucleotide primers will facilitate the detection of multiple analytes derived from the same class of molecule. This invention is of particular relevance for diagnostic or disease screening applications but can also be applied in research settings, scene of crime investigations and in instances that required human identification e.g. identification in mass disaster zones.

In a disease screening application this device is associated with a number of advantages; i) The analysis of a biological sample e.g. blood can be carried out in the proximity of the patient i.e. point of care e.g. a GP clinic. ii) The proposed cost effective system facilitates its use in developing countries where expensive tests, basic laboratory infrastructure and trained personnel are often inaccessible. The method associated with this simple device could be easily carried out by semi-skilled individuals in a resource-limited environment. iii) The lateral flow nature of the device obviates the need for specialized and often prohibitively expensive equipment such as mass spectrophotometers etc.

The device and method as described herein is based upon solid support materials such as cellulose combined with lateral flow and microfluidics. These microfluidic paper-based analytical devices are a new class of point-of-care diagnostic device that are relatively inexpensive, easy to use, and designed specifically for use in the Third World. The fabricated nature of the microfluidic device has the potential to increase the accessibility of molecular diagnostics application for patient care in the Third World. The cellulose-based solid support can be impregnated with chemicals that promote the stabilisation of analytes of interest. For example the FTA technology (GE Healthcare) is known to promote the prolonged storage and stabilization of nucleic acids. Alternatively chemically covalent modified cellulose may be used e.g. nitrated cellulose. Similarly non-impregnated cellulose-based papers such as those used to facilitate neonatal screening for metabolic and genetic diseases could be incorporated into such a device. Incorporating chemically-impregnated cellulose papers into this device will (if required) support the collection and storage of relevant biological samples prior to transportation to centralised laboratories for analysis.

The biological sample is applied to a sample application pad and analytes within the sample are transferred by capillary action to chambers or detection areas possibly containing lyophilised or printed detection reagents such as antibodies or biochemical reagents. These are designed to facilitate the detection of each specific analyte of interest.

The microfluidics device described here consists of a surface to carry the sample from the sample application pad through a series of chambers up to an absorbent pad- which is located at the periphery of the device. Diagnostic analyte levels can be compared to an illustrative mask that describes the normal or acceptable range of each analyte. Alternatively when using antibodies linked to reporter enzymes the device could be developed to permit quantitative measurements that will allow a simple comparison between normal and abnormal analyte levels. Many variations of this set-up are possible including the application of the solubilised blood spot directly to an enclosed device that contains all the reagents required for analysis. Alternate methods would involve a series of biochemical tests located within each chamber which co-locates with the reaction widows allowing a multi-analyte test approach from a single sample, The device would be fabricated using wax-imprinting to generate the fluid channels on the device and substrates would be printed onto the paper beneath the reading window allowing for rapid results.

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A Microfluidics Device for Diagnostic Testing

Introduction

The first step in prevention and treatment of disease is accurate diagnosis, but diagnostic technologies that are successful in the economically developed world often are prohibitively expensive or technologically difficult to use in developing countries. Healthcare providers in such economically challenges countries frequently cannot afford even modestly expensive tests or basic infrastructures i.e., reliable power, refrigeration, and trained personnel. Currently the identification and diagnosis of many diseases requires a highly trained specialist healthcare worker to either recognize symptoms or to perform tests and interpret results associated with expensive diagnostic tests. In impoverished environments highly trained specialised personnel may not be available.

The development of a diagnostic device that is inexpensive, effective and simple to use combined with an easy to interpret technology specifically for developing countries will increase patient access to an improved healthcare service.

Summary of the invention

This invention describes a novel device which is able to perform multiple analyses from a single biological sample through the application of microfluidics with cellulose technologies. The analytes that can be detected include but are not limited to DNA, RNA and protein. The device can be configured to detect different molecules derived from a single class of analyte or configured to detect a range of different analytes e.g. DNA, RNA and protein from a single applied biological sample. The use of differently labelled detection reagents e.g. antibodies, oligonucleotide primers will facilitate the detection of multiple analytes derived from the same class of molecule. This invention is of particular relevance for diagnostic or disease screening applications but can also be applied in research settings, scene of crime investigations and in instances that required human identification e.g. identification in mass disaster zones.

In a disease screening application this device is associated with a number of advantages;

i)             The analysis of a biological sample e.g. blood can be carried out in the proximity of the patient i.e. point of care e.g. a GP clinic.

ii)            The proposed cost effective system facilitates its use in developing countries where expensive tests, basic laboratory infrastructure and trained personnel are often inaccessible. The method associated with this simple device could be easily carried out by semi-skilled individuals in a resource-limited environment.

iii)           The lateral flow nature of the device obviates the need for specialized and often prohibitively expensive equipment such as mass spectrophotometers etc.

The device and method as described herein is based upon solid support materials such as cellulose combined with lateral flow and microfluidics. These microfluidic paper-based analytical devices are a new class of point-of-care diagnostic device that are...