System for automatically testing a fluid specimen

• US 20020081233A1
• Filed: 02/06/2002
• Published: 06/27/2002
• Est. Priority Date: 02/14/1997
• Status: Active Grant

• Current Assignee: Escreen Inc (Abbott Laboratories)
• Original Assignee: Escreen Inc (Abbott Laboratories)
• Inventors: Whitford, Bill, Birkner, David A., Goodin, John W., Lappe, Murray I., Patten, Keith
• Granted Patent: US 6,716,393 B2
• Time in Patent Office: Days
• US Class Current: 422/82.05
• CPC Class Codes: B01L 2200/0605 Metering of fluids
• CPC Class Codes: B01L 2200/141 Preventing contamination, tampering
• CPC Class Codes: B01L 2300/021 Identification, e.g. bar codes
• CPC Class Codes: B01L 2300/025 Displaying results or values with integrated means
• CPC Class Codes: B01L 2300/042 Caps; Plugs
• CPC Class Codes: B01L 2300/046 Function or devices integrated in the closure
• CPC Class Codes: B01L 2300/047 Additional chamber, reservoir
• CPC Class Codes: B01L 2300/0663 Whole sensors
• CPC Class Codes: B01L 2300/069 Absorbents; Gels to retain a fluid
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0478 pistons
• CPC Class Codes: B01L 2400/0683 mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• CPC Class Codes: B01L 3/502715 characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: B01L 3/545 for laboratory containers
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: G01N 33/94 involving narcotics or drugs or pharmaceuticals, neurotransmitters or associated receptors
• CPC Class Codes: G01N 35/00871 : Communications between instruments or with remote terminals
• CPC Class Codes: G06K 19/10 : at least one kind of marking being used for authentication, e.g. of credit or identity cards verification of coded identity or credit cards in mechanisms actuated by them G07F7/12
• CPC Class Codes: G06K 2019/06253 : for a specific application
• CPC Class Codes: G06Q 30/018 : Certifying business or products
• CPC Class Codes: G06V 40/30 : Writer recognition; Reading and verifying signatures
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 10/60 : for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: G16H 40/67 : for remote operation
• CPC Class Codes: Y10T 436/12 : Condition responsive control
• CPC Class Codes: Y10T 436/13 : Tracers or tags
• CPC Class Codes: Y10T 436/25 : including sample preparation

Abstract

A system for automatically testing a fluid specimen, e.g., urine, to indicate the presence of specified chemical components in the specimen. The system preferably utilizes an assaying device comprised of a collection cup and a cap which carries at least one test strip. The device includes an integrated aliquot delivery mechanism actuatable to wet the test strip with an aliquot delivered from the fluid specimen. The assaying device is configured to operate in conjunction with an electronic reader device capable of actuating the aliquot delivery mechanism and reading the reaction of the test strip. A preferred reader device defines a keyed receptacle for accommodating a complementary shaped cup housing in a particular orientation. The reader device is comprised of a camera for capturing the image of a test strip, an actuator for actuating an aliquot delivery mechanism, and a microprocessor/controller for (1) controlling the camera and actuator and (2) processing the image.

Claims

1. Apparatus for use with a device including a test strip for providing a visual indication of specific chemical components present in a fluid specimen, said apparatus comprising:

a camera mounted to image said test strip onto the focal plane of said camera;

a processor operable to (1) control said camera to periodically capture sequential images of said test strip and (2) generate a digital representation of each captured image;

said processor further operable to process said digital representations to detect markings on said image indicative of each of said chemical components in said fluid specimen; and

output means for reporting the detection of said markings.

2. Automatic test apparatus for use with an assaying device having at least one test strip arranged to visually indicate whether specific chemical components are present and/or absent from a fluid specimen, said apparatus comprising:

a support structure for supporting said assaying device and placing said test strip in a predefined position;

a camera having a focal plane;

a mounting structure mounting said camera to image said test strip onto said focal plane;

a programmed microprocessor operable to (1) cause said camera to capture said test strip image and generate a digital representation of the test strip image; and

(2) process said digital representation to detect markings on said image indicative of the presence and/or absence of specific chemical components in said fluid specimen; and

output means for reporting the detection of said markings.

3. The apparatus of claim 2 further including:

a host computer;

a communication network; and

wherein

said output mean including a connectivity device for connecting to said host computer via said communication network.

4. The apparatus of claim 2 further including at least one light source for illuminating said test strip.

5. The apparatus of claim 2 further including a light shield mounted for movement toward said assaying device to minimize stray light on said test strip.

6. The apparatus of claim 2 wherein said assaying device includes a delivery mechanism actuatable to deliver an aliquot of said fluid specimen onto said test strip;

and further including

an actuator operable by said microprocessor for actuating said delivery mechanism.

7. The apparatus of claim 6 wherein said actuator includes a piston mounted for movement into engagement with said delivery mechanism.

8. The apparatus of claim 7 wherein said actuator includes a motor for moving said piston along a linear path.

9. The apparatus of claim 7 further including a light source for illuminating said test strip.

10. The apparatus of claim 9 further including a light shield mounted for movement with said piston to surround said test strip and minimize stray light incident thereon.

11. The apparatus of claim 2 wherein said test strip defines multiple latent lines including at least one drug line associated with a specific chemical component;

and

wherein said test strip is responsive to being wetted by said fluid specimen to produce a visible marking coincident with said latent drug line if said specimen lacks said specific chemical component is absent from said specimen.

12. The apparatus of claim 11 wherein said multiple latent lines includes at least one reference line;

and wherein said test strip is responsive to being wetted by said fluid specimen to produce a visible marking coincident with said latent reference line.

13. The apparatus of claim 12 wherein said microprocessor detects said marking coincident with said reference line by examining a digital representation of pixels in a region extending above and below said reference line.

14. The apparatus of claim 11 wherein said microprocessor detects said marking coincident with said drug line by examining a digital representation of pixels in a region extending above and below said drug line and by relatively comparing the magnitude of pixels along said drug line.

15. The apparatus of claim 2 wherein said test strip is responsive to being wetted by said fluid specimen to produce a visible indication of exogenous components.

16. The apparatus of claim 15 wherein said test strip produces a color change in response to exogenous components indicative of specimen adulteration.

18. The system of claim 17 wherein said test strip defines a latent drug line associated with each specific chemical component;

and

wherein said latent drug line becomes visually apparent in response to said test strip being wetted by a fluid specimen lacking the chemical component associated with that drug line.

19. The system of claim 18 wherein said processor analyzes said digital representation to detect visible drug lines on said test strip, said processor analysis including examining pixels along horizontal pixel rows within a region of said test strip extending vertically above and below the presumed position of a horizontal latent drug line.

20. The system of claim 19 wherein said processor analysis includes comparing pixel rows within said region.

21. The system of claim 20 wherein said processor analysis further includes comparing side and center positions of said horizontal pixel rows.

22. The system of claim 17 further including an assaying device comprising a collection cup and a detachable cap for sealing said cup;

and wherein

said test strip is carried by said cap.

23. The system of claim 22 wherein said mechanism for wetting said test strip includes a plunger in said assaying device actuatable to transport fluid from said collection cup to wet said test strip.

24. The system of claim 23 including a reader housing supporting said camera;

and wherein

said reader housing includes a keyed recess for accommodating said assaying device and placing said test strip in a certain position relative to said camera.

25. The system of claim 24 wherein said reader housing further includes a piston mounted for movement toward said assaying device;

and

means for selectively moving said piston against said plunger to wet said test strip.

26. The system of claim 25 further including a light source energizable to illuminate said test strip.

27. The system of claim 26 further including a light shield for restricting illumination of said test strip to said light source.

28. The system of claim 17 wherein said test strip changes color in response to exogenous components in said fluid specimen indicative of specimen adulteration.

17. A system for locally determining whether a fluid specimen tests “

negative”

for specific chemical components, said system comprising;

a test strip;

a mechanism for selectively wetting said test strip with a portion of said fluid specimen, said test strip being configured to respond to said wetting to visually indicate whether specific chemical components are present and/or absent in said specimen;

a camera for generating a digital representation of the image of said test strip including any visual indications indicating the presence and/or absence of said specific chemical components;

a programmed digital processor for analyzing said digital representation to detect said visual indications and determine whether said specific chemical components are absent from said specimen; and

means responsive to the absence of specific chemical components in said specimen for reporting a “

negative test result.