Integrated Test Device for Optical Detection of Microarrays

• US 20130184188A1
• Filed: 12/21/2012
• Published: 07/18/2013
• Est. Priority Date: 12/23/2011
• Status: Active Grant

• Current Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Point Of Care Incorporated (Abbott Laboratories Incorporated)
• Inventors: Ewart, Thomas, Davis, Graham, Emeric, Pierre, Gershtein, Sergey, Sutrala, Smitha, Di Tullio, Katrina
• Granted Patent: US 9,140,693 B2
• Time in Patent Office: Days
• US Class Current: 506/39
• CPC Class Codes: G01N 2035/00108 Test strips, e.g. paper
• CPC Class Codes: G01N 2035/00128 with pressing or squeezing devices
• CPC Class Codes: G01N 21/253 for batch operation, i.e. multisample apparatus analytical automats G01N35/00
• CPC Class Codes: G01N 21/6452 Individual samples arranged in a regular 2D-array, e.g. multiwell plates
• CPC Class Codes: G01N 33/492 Determining multiple analytes
• CPC Class Codes: G01N 33/53 Immunoassay; Biospecific binding assay; Materials therefor
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence

Abstract

This invention relates generally to devices and methods for performing optical and electrochemical assays and, more particularly, to testing devices having an optically readable microspot array and/or an electrochemical detector and to methods of performing microspot arrays and electrochemical assays using such devices. The present invention is particularly useful for performing immunoassays and/or electrochemical assays at the point-of-care.

Claims

1. A testing cartridge for detection of an analyte in a test sample, said testing cartridge comprising:

at least one electrochemical sensor; and

an optically readable microspot array.

2. The testing cartridge of claim 1, further comprising a barcode that comprises information identifying at least one of:

said testing cartridge, an electrochemical test performed by said testing cartridge, and at least one microspot array test performed by said testing cartridge.

3. The testing cartridge of claim 1, further comprising:

an entry port for receiving said test sample into a holding chamber;

a first conduit comprising said at least one electrochemical sensor; and

a second conduit comprising said optically readable microspot array.

4. The testing cartridge of claim 3, further comprising a plurality of conductivity sensors configured to determine a position of said test sample in said testing cartridge.

5. The testing cartridge of claim 1, wherein said microspot array comprises a qualitative or semi-quantitative test for said analyte.

6. The testing cartridge of claim 5, wherein said qualitative or semi-quantitative microspot array is configured to detect said analyte selected from the group consisting of:

drugs of abuse, classes of cytokines, and inflammatory markers.

7. The testing cartridge of claim 1, wherein said electrochemical sensor is configured to detect said analyte selected from the group consisting of:

hCG, K, Na, Cl, Ca, Mg, pH, pO₂, pCO₂, glucose, urea, creatinine, lactate, CKMB, TnI, TnT, BNP, NTproBNP, proBNP, TSH, D-dimer, PSA, PTH, NGAL, galectin-3, AST, ALT, albumin, phosphate, and ALP.

8. The testing cartridge of claim 1, further comprising an imager chip configured to capture an image of said optically readable microspot array.

9. The testing cartridge of claim 8, wherein said imager chip is a silicon biosensor chip configured to measure a light output of at least one photochemical reaction on said optically readable microspot array.

10. The testing cartridge of claim 1, wherein said optically readable microspot array comprises at least one spot that is a quantum dot.

11. The testing cartridge of claim 1, wherein said optically readable microspot array comprises at least one spot that is a quantum dot or a nanoparticle having properties of fluorescence or phosphorescence singly or in combination with magnetic or paramagnetic properties.

12. The testing cartridge of claim 1, wherein said optically readable microspot array comprises a plurality of spots in a plurality of columns and a plurality of rows.

13. The testing cartridge of claim 1, wherein said optically readable microspot array comprises a plurality of spots that are substantially circular and have a diameter in a range of about 10 um to about 500 um.

14. The testing cartridge of claim 1, further comprising a wash fluid reservoir with a displacement device configured to move a fluid from said wash fluid reservoir into a conduit comprising said optically readable microspot array and washing said test sample from said optically readable microspot array.

15. The testing cartridge of claim 14, wherein a volume of said fluid is in a range of about 10 μ

L to about 500 μ

L.

16. The testing cartridge of claim 15, wherein a volume of said test sample is in a range of about 1 μ

L to about 100 μ

L.

17. The testing cartridge of claim 1, where said optically readable microspot array comprises at least one immobilized antibody.

18. The testing cartridge of claim 17, wherein said at least one immobilized antibody is configured to bind with said analyte selected from the group consisting of:

D-dimer, HSA, inflammatory and traumatic disease markers such as C-reactive protein, NGAL, D-dimer, TNFa, TGFb, IL-1 and IL6;

metabolic disease indicators such as HSA, liver enzymes ALP, ALT, AST, bilirubin, vitamine-D, vitamine-B12, and folic acid;

protein hormones such as TSH, hCG, LH, FSH, prolactin, insulin, and somatostatin;

cardiac disease markers such as cardiac troponins, CK-MB, BNP and Galectin-3;

tumor markers such as PSA, CEA, AFP, CA125, VEGF, BrCa1, and HER2/neu;

hormones such as T3, T4, DHEA, estrogen, and progesterone;

infectious diseases organisms and/or plasma antibodies against infectious disease organisms such as Hepatitis B, HIV, Influenzas A and B, West Nile Virus, Epstein-Barr Virus, Parvovirus, Ebola Virus, Sindbis Virus, Chlamydia, Respiratory Syncytial Virus, Pseudomonas, Klebsiella, Serratia, Salmonella, Bartonella, Giardia, Cryptosporidium, Gonococcus and Treponema;

autoimmune disease markers such as Ro-52, vimentin, RNP-Sm, MBP, Jo-1, Scl-70, gliadin, aquaporin, and cardiolipin; and

drugs of the general grouping antibiotics, antivirals, antiepileptics, antidepressants, narcotics, and immunosuppressives.

19. A testing cartridge for detection of an analyte in a test sample, said testing cartridge comprising:

an entry port for receiving said test sample into a holding chamber;

a first conduit comprising at least one electrochemical sensor; and

a second conduit comprising an optically readable microspot array.

20. The testing cartridge of claim 19, further comprising a barcode that comprises information identifying at least one of:

said testing cartridge, an electrochemical test performed by said testing cartridge, and at least one microspot array test performed by said testing cartridge.

21. The testing cartridge of claim 20, further comprising an imager chip configured to capture an image of said optically readable microspot array and said barcode at a same time.

22. An analyte test cartridge comprising:

a sample entry port configured to receive a test sample;

a displacement device configured to move said test sample through at least a portion of said test cartridge; and

a conduit comprising an optically readable microspot array,

wherein said sample entry port is connected to said optically readable microspot.