A diagnostic device
The diagnostic device addresses the challenge of detecting biological antigens at varying concentrations by using a porous membrane element with immobilized reporter-analyte pairs and reference elements, improving detection accuracy and sensitivity.
Patent Information
- Authority / Receiving Office
- HK · HK
- Patent Type
- Applications
- Current Assignee / Owner
- BIODIAGNOSTICS LTD
- Filing Date
- 2026-05-02
- Publication Date
- 2026-07-17
AI Technical Summary
Existing diagnostic devices lack the ability to efficiently detect and quantify biological antigens at varying concentrations within a biological sample using a porous membrane element.
A diagnostic device with a porous membrane element that immobilizes a second member of a reporter-analyte pair at varying concentrations and includes a reference element with sequential concentrations of the first member, preferably an IgG antibody, to enhance detection accuracy.
Enhances the detection and quantification of biological antigens by providing precise concentration gradients for improved sensitivity and specificity.
Smart Images
Figure 00000001_0000 
Figure 00000001_0001 
Figure 00000002_0000
Abstract
Description
(12) UK Patent Application (19) GB (11) 2700161 (13) A (43) Date of A Publication 05.11.2025 (21) Application No: GB2510138.7 (22) Date of Filing: 04.05.2021 Date Lodged: 25.06.2025 (30) Priority Data: (31) 2006581 (32) 04.05.2020 (33) GB (31) 2016894 (32) 23.10.2020 (33) GB (62) Divided from Application No 2218108 under Section 15(9) of the Patents Act 1977 (71) Applicant(s): Bio-Diagnostics Limited Upton Industrial Estate, Rectory Road, UPTON- UPON-SEVERN, Worcestershire, WR8 0LX (72) Inventor(s): Simon Mico (74) Agent and / or Address for Service: Marks & Clerk LLP 15 Fetter Lane, London, EC4A 1BW (51) INT CL: G01N33 / 569 (2006.01) G01N33 / 543 (2006.01) (56) Documents Cited: US 2020 / 0033337 A1 US 5710005 A (58) Field of Search: INT CL: G01N Other: INTERNET, SEARCH-NPL, SEARCH- PATENT (54) Title of the Invention: A diagnostic device Abstract Title: A diagnostic device (57) A diagnostic device for detecting a first member of a reporter-analyte pair comprising: an inlet for receiving a liquid, biological sample, a porous membrane element comprising a detection portion, the detection portion being in liquid communication with the inlet, wherein the detection portion comprises a second member of the reporter-analyte pair immobilised thereon at a plurality of different concentrations, and wherein the plurality of different concentrations extend between a first point on the detection portion, at which the concentration is highest, through to a second point, at which the concentration of the second member is lowest and at sequential concentrations therebetween.Preferably where the concentrations extend between the first and second point at a series of discreet sites. The second member of the reporter-analyte pair is a biological antigen. Also disclosed is a diagnostic device comprising: a reference element comprising a pre-determined quantity of the first member of the reporter-analyte pair. The reference element is a plurality of reference elements, wherein each of the plurality of elements comprise a sequential concentration of the first member of the reporter-analyte pair and is preferably an IgG antibody. [No figure] 76 Application GB2510138.7 Search report under Section 17 of the Patents Act 1977 Date search completed: 28 July 2025 Claims searched: 1 - 4 International classification Subclass and subgroup Valid from G01N33 / 543 01 / 01 / 2006 G01N33 / 569 01 / 01 / 2006 Field of search Worldwide search of patent documents classified in the following areas of the IPC: G01N Databases used in the preparation of this search report: SEARCH-PATENT, SEARCH-NPL, INTERNET Documents considered to be relevant Patent literature Category Relevant claims Document of relevance A US 20200033337 A1 77 A US 5710005 A Non-patent literature Category Relevant claims Document of relevance Categories Letter or symbol Description X Document indicating lack of novelty or inventive step. Y Document indicating lack of inventive step, if combined with another document of the same category. & Member of the same patent family. A Document indicating technological background.P. Document published on or after the priority date but before the filing date of the present application. E. Earlier application published on or after the filing date of the present application. 78 Abstract A Diagnostic Apparatus Abstract A diagnostic apparatus for detecting a first member of a reporter molecule-analyte pair includes: an inlet for receiving a liquid biological sample; a porous membrane element including a detection portion in communication with the inlet liquid, wherein the detection portion contains a second member of the reporter molecule-analyte pair immobilized thereon, the second member having a plurality of different concentrations, and wherein the plurality of different concentrations extend from a first point of highest concentration on the detection portion to a second point of lowest concentration, and are sequentially distributed therebetween. Preferably, the concentrations extend at a plurality of discrete sites between the first and second points. The second member of the reporter molecule-analyte pair is a biological antigen. A diagnostic apparatus is also disclosed comprising: a reference element containing a predetermined amount of the first member of the reporter molecule-analyte pair. This reference element is a plurality of reference elements, wherein each reference element contains a continuous concentration of the first member of the reporter molecule-analyte pair, and preferably, the first member is an IgG antibody. [No data].
Claims
1. A diagnostic device for detecting a first member of a reporter-analyte pair comprising:an inlet for receiving a liquid, biological sample,a porous membrane element comprising a detection portion, the detection portion being in liquid communication with the inlet,wherein the detection portion comprises a second member of the reporter-analyte pair immobilised thereon at a plurality of different concentrations, andwherein the plurality of different concentrations of the second member of the reportanalyte pair extend between a first point on the detection portion, at which the concentration of the second member of the reporter-analyte pair is highest, through to a second point on the detection portion, at which the concentration of the second member of the reporter-analyte pair is lowest and at sequential concentrations therebetween.
2. The diagnostic device according to claim 1, wherein the plurality of different concentrations of the second member of the reporter-analyte pair extend between the first point and the second point in a substantially continuous gradation of their respective concentrations.
3. The diagnostic device according to claim 1, wherein the plurality of different concentrations of the second member of the reporter-analyte pair extend between the first point and the second point at a series of discrete sites.
4. The diagnostic device according to any one of claims 1 to 3, therein the second member of the reporter-analyte pair is a biological antigen.
5. A diagnostic device for detecting a first member of a reporter-analyte pair comprising:an inlet for receiving a liquid, biological sample,a porous membrane element comprising a detection portion, the detection portion being in liquid communication with the inlet,wherein the detection portion comprises a second member of the reporter-analyte pair immobilised thereon,wherein the porous membrane element further comprises a reference element for indicating a level of the first member of the reporter-analyte pair in the liquid, biological sample, andwherein the reference element comprises a pre-determined quantity of the first 5 member of the reporter-analyte pair immobilised thereon.
6. The diagnostic device according to claim 5, wherein the reference element is a plurality of reference elements.10 7. The diagnostic device according to claim 5, wherein each of the plurality ofreference elements comprises a sequential concentration of the first member of the reporter-analyte pair.
8. The diagnostic device according to any one of claims 5 to 7, wherein the first 15 member of the reporter-analyte pair is an antibody, preferably an IgG antibody.14 08 25CLAIMS:
1. A diagnostic device for detecting a first member of a reporter-analyte pair comprising:an inlet for receiving a liquid, biological sample,a porous membrane element comprising a detection portion, the detection portion being in liquid communication with the inlet,wherein the detection portion comprises a second member of the reporter-analyte pair immobilised thereon at a plurality of different concentrations, andwherein the plurality of different concentrations of the second member of the reportanalyte pair extend between a first point on the detection portion, at which the concentration of the second member of the reporter-analyte pair is highest, through to a second point on the detection portion, at which the concentration of the second member of the reporter-analyte pair is lowest and at sequential concentrations therebetween.
2. The diagnostic device according to claim 1, wherein the plurality of different concentrations of the second member of the reporter-analyte pair extend between the first point and the second point in a substantially continuous gradation of their respective concentrations.
3. The diagnostic device according to claim 1, wherein the plurality of different concentrations of the second member of the reporter-analyte pair extend between the first point and the second point at a series of discrete sites.
4. The diagnostic device according to any one of claims 1 to 3, therein the second member of the reporter-analyte pair is a biological antigen.