Method for testing specimens located at a plurality of service sites

• US 7,943,381 B2
• Filed: 10/27/2006
• Issued: 05/17/2011
• Est. Priority Date: 02/05/1999
• Status: Expired due to Term

• Current Assignee: eScreen (Abbott Laboratories Incorporated)
• Original Assignee: eScreen (Abbott Laboratories Incorporated)
• Inventors: Whitford, Bill, Goodin, John, Birkner, David A., Patten, Keith, Lappe, Murray
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US11/553,836
• Publication Number:
  US 20070048184A1
• Time in Patent Office: 1,663 Days
• Field of Search: 436/56, 422/68.1, 422/99, 422/500, 422/509, 422/3
• US Class Current: 436/56
• 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 method of testing a specimen, wherein the testing is conducted at a service site using a testing device, the method comprising:

enabling entry of donor and client information into a database accessible by a host computer;

enabling a site attendant to access at least one of said donor and client information at a local computer remote from said host computer, wherein said local computer is located at the service site;

providing a specimen container that carries machine readable identification information;

enabling testing of a specimen at the service site using the testing device, wherein the specimen was deposited by a donor into the specimen container and at the service site;

associating the machine readable identification information carried by the specimen container with an electronic chain of custody form to positively associate the deposited specimen with the donor;

enabling electronic communication of the machine readable identification information to the host computer, wherein the communication is conducted across a communications network;

uploading from the testing device and to the host computer remote from the service site a test result associated with the test specimen and obtained from the testing device, wherein the uploading is conducted across a communications network;

generating the electronic chain of custody form that controls a chain of custody procedure for the specimen;

obtaining via an electronic signature pad the donor'"'"'s handwritten signature applied by the donor; and

receiving control instructions for the testing device from the host computer.

2. The method as claimed in claim 1, further including the step of uploading the test result to a computer located at the service site prior to uploading the test result to the host computer.

3. The method as claimed in claim 1, wherein the host computer is operable to control the testing of each specimen.

4. The method as claimed in claim 2, further including the step of instructing the computer located at the service site to display the test result.

5. The method as claimed in claim 1, further including the step of instructing the testing device to upload billing information to the host computer.

6. A method of enabling testing of a specimen received from a donor at service site using a testing device, the method comprising:

enabling entering of donor information into a database;

providing a specimen container that carries machine readable identification information., wherein the specimen was deposited by the donor into the specimen container and at the service site;

associating the machine readable identification information carried by the specimen container with an electronic chain of custody form to positively associate the deposited specimen with the donor;

enabling electronic communication of the machine readable identification information to the host computer, wherein the communication is conducted across a communications network;

enabling a site attendant at the respective service site to test the test specimen using the respective testing device;

enabling uploading from the testing device and to either or both of a local computer or a host computer a test result associated with the test specimen and obtained from the testing device, wherein the uploading is conducted across a communications network;

enabling generating of the electronic chain of custody form that controls a chain of custody procedure for the specimen;

enabling receipt of an electronic signature indicative of the donor'"'"'s handwritten signature and applied by the donor via an electronic signature pad; and

exercising at least some control of the testing device via the host computer.

7. The method as claimed in claim 6, further including uploading billing information from the test device and to the host computer.

8. The method as claimed in claim 6, wherein the database is associated with either or both of the test device and the host computer.