System and apparatus for point-of-care diagnostics

• US 9,207,181 B2
• Filed: 03/01/2013
• Issued: 12/08/2015
• Est. Priority Date: 03/01/2012
• Status: Active Grant

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Egan, Richard L., Hale, Michael Jon, Steadman, Jhobe
• Primary Examiner(s): Crawford, Erik B
• Application Number:
  US13/783,019
• Publication Number:
  US 20130230844A1
• Time in Patent Office: 1,012 Days
• US Class Current: 1/1
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 9/52 Supports specially adapted for flat sample carriers, e.g. for plates, slides, chips
• CPC Class Codes: G01N 2021/6439 with indicators, stains, dyes, tags, labels, marks
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• CPC Class Codes: G01N 21/6486 Measuring fluorescence of biological material, e.g. DNA, RNA, cells G01N21/6428 takes precedence
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2201/12707 Pre-test of apparatus, e.g. dark test, sensor test
• CPC Class Codes: G01N 2201/12792 Compensating own radiation in apparatus
• CPC Class Codes: G01N 2333/11 Orthomyxoviridae, e.g. influenza virus
• CPC Class Codes: G01N 2469/10 Detection of antigens from microorganism in sample from host
• 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 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/56944 Streptococcus
• CPC Class Codes: G01N 33/56983 Viruses

Abstract

A system comprised of an apparatus and a test device is described. The test device and the apparatus are designed to interact to determine the presence or absence of an analyte of interest in a sample placed on the test device.

Claims

1. A system, comprising:

an apparatus comprised of

a housing comprising a drawer movable between an open position and a closed position in which the drawer is contained within the housing;

a carriage movably mounted in the housing, said carriage comprising a source of excitation light and a photodetector for detecting energy emitted;

drive electronics to move the carriage sequentially from a first position to a final position, and a plurality of positions there between, wherein the carriage has a dwell time at each of said plurality of positions between the first and final positions; and

a processor for control of the drive electronics and the carriage and for processing data detected by the photodetector;

a test device comprised of

a label pad on a test strip, the label pad comprised of microparticles comprised of a fluorescing lanthanide compound and an antibody with binding specificity for an analyte of interest;

a plurality of lines on the test strip, positioned downstream from the label pad, the plurality of lines comprising at least a reference line and an analyte-specific test line; and

a bar code label on the test device;

wherein upon insertion of the test device into the drawer of the apparatus and moving the drawer into its closed position,

(i) an optional bar code scanner, if present, obtains information from the bar code label on the test device regarding the analyte of interest to be detected;

(ii) based on the analyte of interest to be detected, the processor selects an analyte-specific measurement protocol wherein the carriage is moved from its first to final position, and at each of said plurality of positions the photodetector detects light emitted from the test strip during an illumination period when the source of excitation light is on and during a dark period when the source of excitation light is not powered on; and

wherein the processor is configured to;

(a) generate a one-dimensional data array of values corresponding to a difference between light emitted in the illumination period and the light emitted in the dark period at each of said plurality of positions, and

(b) using data in the data array corresponding to the reference line, identify a location of data in the array that corresponds to the analyte-specific test line;

wherein the optional bar code scanner is positioned in the housing for reading the bar code label on the test device inserted into the apparatus.

2. The system of claim 1, wherein the drawer comprises at least one arm for positioning the test device in a predefined position for interaction with the movable carriage.

3. The system of claim 1, wherein the source of excitation light is a light emitting diode.

4. The system of claim 3, wherein the light emitting diode emits light at about 365 nm.

5. The system of claim 3, wherein the light emitting diode is provided with at least about 4 mW.

6. The system of claim 1 wherein the apparatus further comprises a socket for insertion of a memory device.

7. The system of claim 6, wherein the memory device has a read only capability or a read-write capability.

8. The system of claim 1, wherein the apparatus further comprises a port for connection with an external instrument.

9. The system of claim 8, wherein the external instrument is selected from a computer, a storage device, an external bar code scanner, and a laboratory instrument.

10. The system of claim 1, wherein the bar code scanner is comprised of a light source, a lens and a light sensor that translates optical impulses into electrical impulses, and wherein one or more mirrors are positioned to achieve interaction of light from the bar code scanner light source and the bar code label on the test device inserted into the apparatus.

11. The system of claim 1, wherein the plurality of lines on the test device is comprised of, in an upstream to downstream direction with respect to flow of fluid on the test strip, a negative control line, the analyte-specific test line, and the reference line.

12. The system of claim 11, wherein the reference line comprises antibodies for non-specific binding to immunoglobulins present in a sample, and based on its fluorescent signal communicates to the processor whether sufficient sample has reached the reference line and provides a positional reference for determining the position of the analyte-specific test line.

13. The system of claim 11, wherein the reference line is dimensionally wider than the analyte-specific test line.

14. The system of claim 11, wherein a first derivative of the data array is calculated, and a minimum peak and a maximum peak corresponding to the reference line is used to determine a cutoff value for analysis of data corresponding to the analyte specific test line.

15. The system of claim 1, wherein the plurality of lines includes a negative control line comprised of antibodies with non-specific binding to immunoglobulins in a sample.

16. The system of claim 15, wherein a first derivative of the data array is calculated, and a minimum peak and a maximum peak corresponding to the negative control line is used to determine a cutoff value for analysis of data corresponding to the analyte specific test line.

17. The system of claim 1, wherein the fluorescing lanthanide compound is europium.

18. The system of claim 17, wherein the microparticles are comprised of a europium core with a polystyrene exterior.

19. The system of claim 1, wherein a splash shield is positioned between the test device and the carriage to protect the photodetector and/or source of excitation light from sample on the test device.

20. The system of claim 1, wherein a sample placed on the test device flows in an upstream to a downstream direction, from a sample pad downstream to a region comprising he plurality of lines, and wherein the movable carriage scans the test device in a downstream to upstream direction.

21. A kit, comprising:

the system according to claim 1; and

a calibration cassette comprised of at least two lines that fluoresce upon excitation with the light source.

22. The kit of claim 21, wherein the at least two lines that fluoresce are comprised of an optical brightener compound disposed on a polymeric substrate.