System for automatically testing a fluid specimen

• US 6,514,461 B1
• Filed: 11/24/1999
• Issued: 02/04/2003
• Est. Priority Date: 02/14/1997
• Status: Expired due to Term

• Current Assignee: eScreen (Abbott Laboratories Incorporated)
• Original Assignee: eScreen (Abbott Laboratories Incorporated)
• Inventors: Whitford, Bill, Birkner, David A., Goodin, John W., Lappe, Murray I., Patten, Keith
• Primary Examiner(s): Warden; Jill
• Assistant Examiner(s): CROSS, LATOYA I
• Application Number:
  US09/444,926
• Time in Patent Office: 1,168 Days
• Field of Search: 422/68.1,82.05,119,63
• US Class Current: 422/68.1
• 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. A system for locally determining whether a fluid specimen tests “

negative”

for specific chemical components, said system comprising;

an assaying device comprising a cup for collecting said fluid specimen and a detachable cap for sealing said cup;

said cap carrying a test strip;

a pump mechanism carried by said cap actuatable without tilting said cup for extracting an aliquot of fluid specimen from said cup for wetting said test strip, said test strip being configured to respond to wetting by said aliquot for producing visual indications representing whether specific chemical components are present and/or absent in said specimen;

a camera for generating a digital representation of an image incident thereon;

a positioning device for placing said assaying device relative to said camera to enable said camera to generate a digital representation of said test strip including any visual indications indicating the presence and/or the absence of said specific chemical components in said specimen;

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

an output device responsive to said processor determining the absence of specific chemical components in said specimen for reporting a “

negative”

test result.

2. The system of claim 1 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.

3. The system of claim 2 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.

4. The system of claim 3 wherein said processor analysis includes comparing pixel rows within said region.

5. The system of claim 4 wherein said processor analysis further includes comparing side and center positions of said horizontal pixel rows.

6. The system of claim 1 including a plunger in said assaying device actuatable to transport an aliquot of said specimen from said cup to said test strip.

7. The system of claim 6 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.

8. The system of claim 7 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.

9. The system of claim 8 further including a light source energizable to illuminate said test strip.

10. The system of claim 9 further including a light shield for restricting illumination of said test strip to said light source.

11. The system of claim 1 wherein said test strip changes color in response to exogenous components in said fluid specimen indicative of specimen adulteration.