Test kits and devices

• US 6,951,631 B1
• Filed: 09/23/1997
• Issued: 10/04/2005
• Est. Priority Date: 09/27/1996
• Status: Expired due to Fees

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories)
• Inventors: Lenko, Peter, Pearson, Michael T., Catt, Michael
• Primary Examiner(s): Smith, L. F.
• Assistant Examiner(s): PORTNER, VIRGINIA ALLEN
• Application Number:
  US08/935,717
• Time in Patent Office: 2,933 Days
• Field of Search: 422/58, 422/56, 422/61, 422/82.05, 422/82.09, 422/82.02, 422/68.1, 436/514, 436/65, 436/165, 436/169, 436/35, 436/518, 435/7.91, 435/7.93, 435/7.94, 435/7.9, 435/7.1, 600/551, 356/446
• US Class Current: 422/404
• 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 an analyte in a fluid sample, said test kit comprising;

an assay device, said assay device having a detection zone, wherein the presence of the analyte in the fluid sample is indicated by accumulation of a labeled reagent within the detection zone; and

(b) a reading device effective to detect labeled reagent, said reading device comprising means for initiation of the reading device to detect labeled reagent in the detection zone,

wherein the means for initiation of said reading device comprises a switch actuator, and wherein said assay device comprises a contact portion, said contact portion and said switch actuator engaging in a lock-and-key engagement,

wherein the reading device further comprises means for pressing an assay device inserted into the reading device against the switch actuator,

wherein the reading device further comprises a cam that deflects the assay device away from the switch actuator unless the assay device is correctly positioned within the reading device,

wherein the assay device is elongate, and wherein the reading device has a slot into which the assay device is at least partially inserted through a mouth for reading of the assay device, and wherein the slot has at least one projecting lip portion extending over the mouth of the slot, said lip portion acting to retain the assay device within the slot when correctly positioned therein,

wherein said means for initiation of the reading device engages the assay device in a lock-and-key interaction, thereby forming a lock-and-key interaction between the reading device and the assay device whereby the reading device is initiated in response to and only when said assay device is properly positioned in lock-and-key engagement within said reading device and the lock-and-key interaction is formed.

2. The test kit of claim 1, wherein said assay device comprises a porous carrier strip disposed within a hollow casing, said porous carrier strip having the detection zone, and wherein an assay result is revealed by specific binding of the labeled reagent within the detection zone.

3. The test kit of claim 2, wherein the switch actuator comprises a fixed projecting portion and a displaceable projecting portion, and wherein the contact portion has

a recess for receiving the fixed projecting portion, but not the displaceable projecting portion, when the assay device is correctly positioned in the reading device;

and

an interface portion that contacts and displaces the displaceable projecting portion when the assay device is correctly positioned in the reading device.

4. The test kit of claim 2, wherein the projecting lip portion is disposed at an end of the slot, and engages an end of the elongate assay device during insertion of the assay device into the slot.

5. The test kit of claim 1, wherein the projecting lip portion is disposed at an end of the slot, and engages an end of the elongate assay device during insertion of the assay device into the slot.

6. A test kit for determining qualitatively or quantitatively the presence of an analyte in a fluid sample, said test kit comprising;

an assay device, said assay device having a detection zone, wherein the presence of the analyte in the fluid sample is indicated by accumulation of a labeled reagent within the detection zone; and

(b) a reading device effective to detect labeled reagent, said reading device comprising means for initiation of the reading device to detect labeled reagent in the detection zone,

wherein the means for initiation of said reading device comprises a switch actuator, and wherein said assay device comprises a contact portion, said contact portion and said switch actuator engaging in a lock-and-key engagement,

wherein the switch actuator comprises a fixed projecting portion and a displaceable projecting portion, and wherein the contact portion has

a recess for receiving the fixed projecting portion, but not the displaceable projecting portion, when the assay device is correctly positioned in the reading device; and

an interface portion that contacts and displaces the displaceable projecting portion when the assay device is correctly positioned in the reading device,

wherein the reading device further comprises means for pressing an assay device inserted into the reading device against the switch actuator,

wherein the reading device further comprises a cam that deflects the assay device away from the switch actuator unless the assay device is correctly positioned within the reading device,

wherein the assay device is elongate, and wherein the reading device has a slot into which the assay device is at least partially inserted through a mouth for reading of the assay device, and wherein the slot has at least one projecting lip portion extending over the mouth of the slot, said lip portion acting to retain the assay device within the slot when correctly positioned therein,

wherein said means for initiation of the reading device engages the assay device in a lock-and-key interaction, thereby forming a lock-and-key interaction between the reading device and the assay device whereby the reading device is initiated in response to and only when said assay device is properly positioned in lock-and-key engagement within said reading device and the lock-and-key interaction is formed.

7. The test kit of claim 6, wherein the projecting lip portion is disposed at an end of the slot, and engages an end of the elongate assay device during insertion of the assay device into the slot.

8. A test kit for determining qualitatively or quantitatively the presence of an analyte in a fluid sample, said test kit comprising:

(a) an assay device, said assay device having a detection zone, wherein the presence of the analyte in the fluid sample is indicated by accumulation of a labeled reagent within the detection zone; and

(b) a reading device effective to detect labeled reagent, said reading device comprising means for initiation of the reading device to detect labeled reagent in the detection zone,

wherein said means for initiation of the reading device engages the assay device in a lock-and-key interaction, whereby the reading device is initiated in response to and only when said assay device is properly positioned in lock-and-key engagement within said reading device, wherein the assay device is elongate, and wherein the reading device has a slot into which the assay device is at least partially inserted through a mouth for reading of the assay device, and wherein the slot has at least one projecting lip portion extending over the mouth of the slot, said lip portion acting to retain the assay device within the slot when correctly positioned therein.