Medical test kit

• US 5,658,801 A
• Filed: 01/04/1995
• Issued: 08/19/1997
• Est. Priority Date: 05/03/1994
• Status: Expired due to Fees

• Current Assignee: Spectral Diagnostics, Inc.
• Original Assignee: Spectral Diagnostics, Inc.
• Inventors: Lea, Peter, Poissant, Philip
• Primary Examiner(s): Chin, Christopher L.
• Application Number:
  US08/368,791
• Time in Patent Office: 958 Days
• Field of Search: 422/55-58, 422/61, 422/99, 422/101, 422/102, 435/810, 435/970, 435/975, 435/287.1, 435/287.2, 435/287.7, 435/287.9, 435/288.4, 435/288.5, 436/518, 436/514, 436/805, 436/810
• US Class Current: 436/518
• CPC Class Codes: B01L 2200/026 Fluid interfacing between devices or objects, e.g. connectors, inlet details
• CPC Class Codes: B01L 2300/0681 Filter
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 33/54366 Apparatus specially adapted for solid-phase testing
• CPC Class Codes: Y10S 435/81 Packaged device or kit
• CPC Class Codes: Y10S 435/97 Test strip or test slide
• CPC Class Codes: Y10S 435/975 Kit
• CPC Class Codes: Y10S 436/805 Optical property
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick

Abstract

A medical diagnostic test kit includes a rectangular flat bottom member having an external raised flange and an internal raised flange forming a cavity therein; an elongated dry chemistry membrane held within the cavity; an arcuate cover member secured to the bottom member with the membrane therebetween; and a funnel assembly comprising a funnel member removably attached to the cover member with its nozzle portion extending into a sample opening in the cover member.

Claims

1. A medical diagnostic test kit for use with a body fluid of a patient comprising:

(i) a bottom member forming a flat bottom wall and having joinder means to join said bottom member to a cover member defined below;

(ii) an elongated dry chemistry test membrane having at least one reagent which reacts with said body fluid;

(iii) a cover member having joinder means to join said cover member to said bottom member and having a receiving opening to receive said body fluid and a display window opening to display at least a part of said test membrane, wherein said test membrane is held between said bottom member and said cover member; and

(iv) a removable funnel assembly comprising a funnel member that fits within the receiving opening of said cover member, having a hollow nozzle portion, a separation membrane in contact with said nozzle portion and extending arcuately about said nozzle portion and means to removably attach said funnel assembly to said cover member.

2. A kit as in claim 1 wherein said bottom member has a raised flange around said bottom wall.

3. A kit as in claim 1 and further including a flange integral with said bottom member and forming an elongated cavity.

4. A kit as in claim 3 wherein said membrane is positioned within said elongated cavity.

5. A kit as in claim 1 wherein said test membrane is positioned in contact with said receiving opening and said display window opening.

6. A kit as in claim 1 wherein said funnel assembly comprises a funnel holder having means to removably attach said funnel assembly to said cover member, a funnel member communicating with said funnel holder for receiving said patient'"'"'s body fluid, said funnel member defining a nozzle portion, said nozzle portion defining at least one opening for egress of said body fluid toward said test membrane, and a separation membrane for filtration and delivery of said body fluid to said test membrane, said separation membrane being in substantially continuous contact with said nozzle portion and in substantially uniform fluid communication with said at least one opening defined therein.

7. A kit as in claim 6 wherein said separation membrane is non-adhesively held against said nozzle portion.

8. A kit as in claim 6 wherein said separation membrane, by means of enhanced surface juxtaposition achieved through compound curvature and projection thereof beyond said nozzle portion, makes capillary contact with said test membrane.

9. A kit as in claim 6 wherein said nozzle portion defines a plurality of openings.

10. A kit as in claim 9 wherein said nozzle portion defines a plurality of openings, and said frame member defines a plurality of openings for producing substantially uniform fluid communication with said openings in said nozzle portion.

11. A kit as in claim 6 wherein said funnel member further includes as a part thereof a frame member outwardly disposed with respect to said nozzle portion which engages and retains said nozzle portion, and cooperates with said nozzle portion to wrap and hold said separation membrane in sandwich-like relationship between said nozzle portion and said frame member, whereby said separation membrane is maintained in substantially continuous contact with said nozzle portion.

12. A kit as in claim 11 wherein said frame member defines a capturing rim for engagement of said funnel member and said separation membrane when said frame member is assembled therewith.

13. A kit as in claim 12 wherein said capturing rim defines means for the snap-fittable engagement of said funnel member.

14. A kit as in claim 12 wherein said capturing rim defines means for frictional engagement of said said separation membrane and said funnel member.

15. A kit as in claim 14 wherein said capturing rim defines a curved circumference along at least a part of a cross-section thereof for frictional engagement of said separation member and said funnel member.

16. A medical diagnostic test kit for use with a body fluid of a patient comprising:

(i) a bottom member forming a rectangular flat bottom wall and having a raised flange around the bottom wall to join said bottom member to a cover member defined below, and an integral internal flange forming an elongated cavity;

(ii) an elongated dry chemistry test membrane within said cavity and having at least one reagent which reacts with said patient'"'"'s body fluid;

(iii) an arcuate cover member having joinder means to join said cover member to said bottom member and having a receiving opening to receive said body fluid and a display window opening to display at least part of said membrane;

where said membrane is held between said bottom member and said cover member and in contact with said receiving opening and said display window opening;

(iv) a readily detachable funnel assembly comprising a funnel member having a hollow nozzle portion which fits within said receiving opening, means to removably attach said funnel assembly to said cover member, and a separation membrane means to separate red blood cells from serum and positioned in substantially uniform fluid communication with said nozzle portion.

17. A medical diagnostic test kit for use with a whole blood sample of a patient comprising:

(i) a bottom member forming a rectangular flat bottom wall and having a raised flange around the bottom wall to join said bottom member to a cover member defined below, and an integral internal flange forming an elongated cavity;

(ii) an elongated dry chemistry test membrane within said cavity and having at least one reagent which reacts with said patient'"'"'s whole blood sample;

(iii) an arcuate cover member having joinder means to join said cover member to said bottom member and having a receiving opening to receive said body fluid and a display window opening to display at least part of said membrane;

where said membrane is held between said bottom member and said cover member and in contact with said receiving opening and said display window opening;

(iv) a funnel assembly comprising a funnel member having a hollow nozzle portion which fits within said receiving opening, wherein said funnel assembly is permanently attached to said cover member.