NZ738669B2 - Liquid distribution and diagnostic device and system - Google Patents

Liquid distribution and diagnostic device and system

Info

Publication number
NZ738669B2
NZ738669B2 NZ738669A NZ73866916A NZ738669B2 NZ 738669 B2 NZ738669 B2 NZ 738669B2 NZ 738669 A NZ738669 A NZ 738669A NZ 73866916 A NZ73866916 A NZ 73866916A NZ 738669 B2 NZ738669 B2 NZ 738669B2
Authority
NZ
New Zealand
Prior art keywords
diagnostic device
layer
detection
zone
hydrophilic layers
Prior art date
Application number
NZ738669A
Other versions
NZ738669A (en
Inventor
David Bashforth
Gil Garnier
Heather Mcliesh
Wei Shen
Junfei Tian
Original Assignee
Monash University
Filing date
Publication date
Application filed by Monash University filed Critical Monash University
Priority claimed from PCT/AU2016/050516 external-priority patent/WO2016205875A1/en
Publication of NZ738669A publication Critical patent/NZ738669A/en
Publication of NZ738669B2 publication Critical patent/NZ738669B2/en

Links

Classifications

    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7756—Sensor type
    • G01N2021/7766—Capillary fill
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7793—Sensor comprising plural indicators
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/75—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated
    • G01N21/77—Systems in which material is subjected to a chemical reaction, the progress or the result of the reaction being investigated by observing the effect on a chemical indicator
    • G01N2021/7796—Special mountings, packaging of indicators
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N21/00—Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light
    • G01N21/84—Systems specially adapted for particular applications
    • G01N21/8483—Investigating reagent band
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525—Multi-layer analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/52—Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements
    • G01N33/525—Multi-layer analytical elements
    • G01N33/526—Multi-layer analytical elements the element being adapted for a specific analyte
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54391—Immunochromatographic test strips based on vertical flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/80—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving blood groups or blood types or red blood cells

Abstract

diagnostic device for analysing properties of an analyte in a sample liquid including a distribution zone having at least two hydrophilic layers placed one on top of the other with a gap in-between. One layer is a top layer (12) and another layer is a bottom layer (13). A detection zone is located under the distribution zone. The detection zone has a detection layer (14) with a binding element for identifying the properties of the analyte in the biofluid. The top layer has one or more openings (15) through which the sample liquid is introduced into the device. The bottom layer has a pattern containing at least one of: grooves, holes, and strips by which the biofluid sample distributed from the top layer is distributed by capillary action to reach the detection layer. The detection layer has text or symbols thereon providing a visual indication of the properties of the analyte in the biofluid sample when the biofluid sample comes into contact with the binding element. Many bispecific reagents when bound to a surface render the surface hydrophobic, limiting wetting by most biofluids, and hence limiting the applications where such devices can be used. The present invention provides a separate distribution and detection zone, allowing the use of a hydrophilic distribution zone to distribute the biofluid onto a hydrophobic detection zone.

Claims (21)

THE CLAIMS DEFINING THE INVENTION ARE AS FOLLOWS:
1. A diagnostic device for analysing properties of an analyte in a biofluid sample including: a distribution zone having at least two hydrophilic layers placed one on top of another with a gap therebetween, wherein one layer is a top layer and another layer is a bottom layer; and a detection zone located under the distribution zone, the detection zone having a detection layer with a binding element for identifying the properties of the analyte in the biofluid, wherein: the top layer has one or more openings through which the biofluid sample is introduced into the device, and a pattern of holes by which the biofluid sample introduced via the top layer’s opening is distributed by capillary action to reach the bottom layer; the bottom layer also has a pattern containing at least one of: grooves, holes, and strips by which the biofluid sample distributed from the top layer is distributed by capillary action to reach the detection layer; and the detection layer has text or symbols thereon providing a visual indication of the properties of the analyte in the biofluid sample when the biofluid sample comes into contact with the binding element.
2. A diagnostic device according to claim 1, wherein the gap between the hydrophilic layers is between 1 nm to 1 mm.
3. A diagnostic device according to claim 2, wherein the gap between the hydrophilic layers is formed by adhesive connecting the hydrophilic layers together. 20536389_1 (GHMatters) P40661NZPC
4. A diagnostic device according to claim 1, further including a gap between the distribution zone and the detection zone, the gap being between 1 nm to 1 mm in height.
5. A diagnostic device according to claim 4, wherein the gap between the distribution zone and the detection zone is formed by an adhesive connecting the zones together.
6. A diagnostic device according to any one of the preceding claims wherein each hydrophilic layer is a film.
7. A diagnostic device according to any one of the preceding claims wherein the hydrophilic layers are made of paper, non-woven material, metal, inorganic material or polymer.
8. A diagnostic device according to any one of the preceding claims, wherein the hydrophilic layers are surface treated to enhance water/liquid wettability, including plasma treatment, radiation treatment, surface coating, adsorption of surfactant or polymer, or adsorption of biomolecules.
9. A diagnostic device according to claim 8 wherein the hydrophilic layers are made of material in which the contact angle formed by a droplet of biofluid sample to be analysed is less than 90 degrees.
10. A diagnostic device according to any one of the preceding claims, wherein the hydrophilic layers are clear or translucent.
11. A diagnostic device according to any one of the preceding claims, wherein the detection zone includes a hydrophilic semi-permeable layer that can perform filtration or elution for sample preparation prior to being detected on the detection layer. 20536389_1 (GHMatters) P40661NZPC
12. A diagnostic device according to any one of the preceding claims, wherein the binding element includes antibodies and antigen.
13. A diagnostic device according to any one of the preceding claims, wherein the detection layer or a surface of the detection layer is made of paper, cellulosic or non-woven material.
14. A diagnostic device according to any one of the preceding claims, wherein the device is to be used for blood analysis or blood typing.
15. A diagnostic device according to claim 1 wherein the hydrophilic layers are made of polyolefin, polyester, cellulosics, polyurethane, polystyrene, polycarbonate and their copolymers and blends.
16. A diagnostic device according to claim 1 wherein the hydrophilic layers are made of polyethylene, polypropylene, polyethylene terephthalate, polylactide and their copolymers and blends.
17. A method of using a diagnostic device according to any one of the preceding claims, including: a) introducing the biofluid sample through the one or more openings of the top layer, and subsequently b) viewing the visual indication results on the detection layer.
18. A method according to claim 17 including introducing an eluent through the one or more openings of the top layer.
19. A diagnostic system incorporating a diagnostic device according to any one of claims 1 to 16. 20536389_1 (GHMatters) P40661NZPC
20. A diagnostic test kit incorporating a diagnostic device according to any one of claims 1 to 16.
21. A blood bag incorporating a diagnostic device according to any one of claims 1 to 16.
NZ738669A 2016-06-17 Liquid distribution and diagnostic device and system NZ738669B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
AU2015902487A AU2015902487A0 (en) 2015-06-26 Liquid distribution and diagnostic device and system
AU2015903162A AU2015903162A0 (en) 2015-08-07 Liquid distribution and diagnostic device and system
PCT/AU2016/050516 WO2016205875A1 (en) 2015-06-26 2016-06-17 Liquid distribution and diagnostic device and system

Publications (2)

Publication Number Publication Date
NZ738669A NZ738669A (en) 2024-01-26
NZ738669B2 true NZ738669B2 (en) 2024-04-30

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