System for collecting and locally analyzing a fluid specimen

• US 6,342,183 B1
• Filed: 02/05/1999
• Issued: 01/29/2002
• 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, Goodin, John W., Patten, Keith, Lappe, Murray
• Primary Examiner(s): Warden, Jill
• Assistant Examiner(s): CROSS, LATOYA I
• Application Number:
  US09/245,175
• Time in Patent Office: 1,089 Days
• Field of Search: 422/68.1, 422/55, 422/58, 422/82.05, 436/165, 436/178, 436/536
• US Class Current: 422/417
• 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 2300/042 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 2300/0832 cylindrical, tube shaped
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 2400/0478 pistons
• 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 3/5027 by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• 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: 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: G16H 10/40 for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: Y10S 436/807 : Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/808 : Automated or kit
• CPC Class Codes: Y10T 436/255 : including use of a solid sorbent, semipermeable membrane, or liquid extraction

Abstract

A method and apparatus for collecting a fluid specimen, locally analyzing the specimen to qualitatively detect specified chemical components at concentrations above threshold levels, and providing machine readable test results for facilitating data collection and reporting. The apparatus includes an assaying device comprised of a cup for collecting a fluid specimen and a cap carrying at least one test strip for visually reacting to one or more specified chemical components in the specimen. The cap also carries an aliquot delivery mechanism for forcing an aliquot of the fluid specimen onto the test strip. The assaying device is preferably configured to interact with a reader device capable of reading the reaction of the test strip to produce a data output.

Claims

1. An assaying device comprising:

a cup defining an interior volume for accommodating a fluid specimen;

a cap configured for mounting on said cup to seal said interior volume;

at least one test strip carried by said cap; and

a pump mechanism carried by said cap actuatable to force an aliquot of said fluid specimen onto said test strip without contaminating the remainder of said fluid specimen.

2. The device of claim 1 wherein said pump mechanism includes:

a passageway having an inlet located to contact a fluid specimen in said cup and an outlet located to deliver an aliquot of said specimen to said test strip.

3. The device of claim 2 wherein said pump mechanism defines a pump chamber;

and

a pump element mounted for movement in said pump chamber to force fluid therefrom into said passageway inlet for delivery to said test strip.

4. The device of claim 3 wherein said cap is configured to enable a force produced external to said cap to move said pump element.

5. The device of claim 1 wherein said cap defines a compartment for accommodating said test strip;

and

a transparent area formed in said cap proximate to said compartment for visual observation of said test strip.

6. The device of claim 5 wherein said pump mechanism further includes a passageway having an inlet located to contact a fluid specimen in said cup and an outlet located to deliver an aliquot of said specimen to said compartment.

7. The device of claim 6 further including a catch basin located adjacent to said compartment for collecting fluid overflow therefrom.

8. The device of claim 1 wherein said cup defines an interior surface including a floor portion and a peripheral wall portion;

and wherein said delivery mechanism includes;

a partition configured to cooperate with said interior surface to isolate a portion of a specimen in said cup.

9. The device of claim 8 wherein said pump mechanism partition comprises a first tubular wall surface desending from said cap to form a closed chamber for isolating said specimen portion;

and

a passageway having an inlet communicating with said chamber and an outlet located to deliver an aliquot from said isolated specimen portion to said test strip.

10. The device of claim 9 wherein said pump mechanism further includes a pump element selectively actuatable to force an aliquot of said isolated specimen portion through said passageway to said test strip.

11. The device of claim 10 wherein said pump element comprises a plunger mounted for linear movement within said first tubular wall surface;

and wherein

said cap is configured to permit a force produced external to said cup to move said plunger.

12. The device of claim 10 further including a second tubular wall surface mounted within said first tubular wall surface and defining said passageway therebetween;

and wherein

said pump element comprises a plunger mounted for linear movement within said second tubular wall surface for acting on said isolated specimen portion to force an aliquot therefrom through said passageway; and

an opening in said cap for enabling an external member to move said plunger.

13. The device of claim 1 wherein said test strip reacts to wetting by said aliquot to visually indicate the presence of a certain chemical component in said aliquot.

14. The device of claim 1 wherein said test strip reacts to wetting by said aliquot to visually indicate whether said aliquot comprises freshly voided unadulterated human urine.

15. An assaying device for collecting and analyzing a fluid specimen, and device comprising;

a cup defining an interior volume for accommodating a fluid specimen;

a cap configured for mounting on said cup to seal said interior volume;

at least one compartment defined in said cap containing a test strip which provides a visual indication when contacted by a certain chemical;

said cap defining a passageway including an inlet located to contact said specimen in said interior volume and an outlet located proximate to said compartment; and

a pump mounted on said cap actuatable to drive an aliquot of said specimen from said inlet to said outlet for delivery to said test strip without contaminating the remainder of said specimen.

16. The device of claim 15 wherein said cap is configured to define a chamber for capturing and isolating a portion of said specimen;

and wherein

said passageway inlet is located in said chamber in contact with said isolated specimen.

17. The device of claim 16 wherein said pump includes a pump element mounted for movement to bear against said isolated specimen portion to force an aliquot therefrom through said passageway.

18. The device of claim 17 wherein said cap is configured to allow an external force to be applied to move said pump element.

19. The device of claim 15 wherein said cap is configured to permit visual observation of said test strip by an imager mounted external to said assaying device.

20. The device of claim 15 wherein said cap defines a transparent area for enabling visual observation of said test strip through said cap.