Test kits and devices

• US 20060083658A1
• Filed: 09/30/2005
• Published: 04/20/2006
• Est. Priority Date: 09/27/1996
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Lenko, Peter, Pearson, Michael T., Catt, Michael
• Granted Patent: US 7,632,460 B2
• Time in Patent Office: Days
• US Class Current: 422/56
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04

Abstract

A test kit for determining qualitatively or quantitatively the presence of one or more analytes in a fluid sample, comprising an assay device together with a reading device which engages with the assay device and wherein precisely located engagement of the assay device with the reading device is essential for accurate reading of the assay result, wherein precisely located engagement of the assay device with the reading device causes a ‘lock-and-key’ interaction, ie. a unique 3-dimensional interaction, between the assay device and reading initiation means of the reading device. Preferably the reading initiation means includes switch actuating means comprising at least one fixed projecting portion and at least one displaceable projecting portion, and a contact portion of the assay device casing comprises a recess shaped to accommodate the fixed projecting portion of the switch actuating means but not the displaceable projecting portion thereof, the contact portion also comprising an interface portion that contacts and displaces the displaceable portion of the switch actuating means when the fixed projecting portion is accommodated within the recess.

Claims

1. A test kit for determining qualitatively or quantitatively the presence of one or more analytes in a fluid sample, comprising an assay device for sampling and assaying said fluid together with a reading device which engages with said assay device and wherein precisely located engagement of said assay device with said reading device is essential for accurate reading of the assay result, wherein precisely located engagement of said assay device with said reading device causes a ‘

lock-and-key’

interaction between said assay device and reading initiation means of said reading device.

2. A test kit according to claim 1, wherein said assay device is of the type consisting essentially of a porous carrier strip or the like within a hollow casing and wherein an assay result is revealed by specific binding of a labelled reagent within a detection zone of said carrier strip, the presence of the labelled reagent within said detection zone being discernable by said reading device.

3. A test kit according to claim 1 wherein said reading device includes receiving means for receiving said assay device, and said reading initiation means comprises switch actuating means or the like which is displaceable upon receipt of said assay device within said receiving means, wherein correct receipt of said assay device causes a contact portion of said casing to contact said displaceable switch actuating means, the contact portion and the displaceable switch actuating means being cooperatively engageable via a ‘

lock-and-key’

engagement such that only upon correct receipt of said assay device can said switch actuating means be displaced to initiate reading.

4. A test kit according to claim 3, wherein said switch actuating means comprises at least one fixed projecting portion and at least one displaceable projecting portion, and said assay device casing comprises a recessed contact portion to accommodate said fixed projecting portion of said switch actuating means but not the displaceable projecting portion thereof, said contact portion also comprising an interface portion that contacts and displaces said displaceable portion of the switch actuating means when said fixed projecting portion is accommodated within said recessed contact portion.

5. A test kit according to claim 4, wherein said receiving means incorporates biasing means that presses said received assay device against said switch actuating means.

6. A test kit according of claim 4, wherein said receiving means incorporates cam means that deflects said assay device away from said switch actuating means unless said assay device is correctly received by said receiving means.

7. A test kit according to claim 6, wherein said cam means provides a ‘

snap’

engagement of said assay device with said receiving means when said assay device is correctly received.

8. A test kit according to claim 7 wherein said assay device is elongate and engages with slotted receiving means into which at least part of said elongate assay device can fit, said slotted receiving means having at least one projecting lip portion extending over the mouth of the slot and acting to retain said assay device within said receiving means when correctly received therein.

9. A test kit according to claim 8, wherein said projecting lip portion is at one end of said slot and can engages one end of said elongate assay device during insertion of said assay device into the receiving means.

10. A test kit according to claim 9, wherein there is a second projecting lip portion at or near the other end of said slot to retain said inserted assay device in said receiving means.