Reading devices and assay devices for use therewith

• US 6,235,241 B1
• Filed: 05/14/1998
• Issued: 05/22/2001
• Est. Priority Date: 11/12/1993
• Status: Expired due to Term

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Unipath Limited (Abbott Laboratories Incorporated)
• Inventors: Catt, Michael, Mundill, Paul Henry, Prior, Michael Evans
• Primary Examiner(s): SNIDER, THERESA T
• Application Number:
  US09/078,501
• Time in Patent Office: 1,104 Days
• Field of Search: 422/82.05, 422/82.09, 422/61, 422/56, 422/57, 422/58, 356/432, 356/443
• US Class Current: 422/404
• CPC Class Codes: B01L 2200/12 Specific details about manufacturing devices
• CPC Class Codes: B01L 2300/0825 Test strips
• 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 2021/8618 with an optically integrating part, e.g. hemisphere
• CPC Class Codes: G01N 2021/8654 Mechanical support; Mounting of sheet
• 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
• CPC Class Codes: G01N 2201/06153 the sources being LED's
• CPC Class Codes: G01N 2201/0696 Pulsed

Abstract

An assay result reader, for use in conjunction with an assay device comprising a porous liquid-permeable carrier in the form of a strip or sheet through the thickness of which electromagnetic radiation is transmissible, the carrier including a detection zone in which an assay result is revealed by specific binding of a detectable material directly or indirectly to a binding agent immobilized in the detection zone, detection of the detectable material being effected by determining the extent to which electromagnetic radiation transmitted through the thickness of said carrier is attenuated by the presence of the detectable material bound in the detection zone.

Claims

1. An assay result reader, for use in conjunction with an assay device which comprises a porous liquid-permeable carrier in the form of as trip or sheet through the thickness of which electromagnetic radiation is transmissible, said carrier including a detection zone in which an assay result is revealed by specific binding of a detectable material directly or indirectly to a binding agent immobilized in said detection zone, detection of said detectable material being effected by determining the extent to which electromagnetic radiation transmitted through the thickness of said carrier is attenuated by the presence of said detectable material bound in said detection zone, said assay result reader comprising:

a) receiving means for receiving at least a portion of said assay device, said portion including said detection zone;

b) reading means associated with said receiving means said reading means comprising;

(i) at least one source of electromagnetic radiation;

(ii) one or ore sensors capable of detecting the intensity of said electromagnetic radiation, said source and said one or more sensors being positioned such that when said portion of said assay device is received within said receiving means, said detection zone is disposed in the electromagnetic radiation path between said source and said one or more sensor; and

(iii) a diffuser in front of said one or more sensors and downstream of said assay device such that electromagnetic radiation from said source must pass through said diffuser before reaching said one or more sensors, said detection zone of said assay device being disposed in the electromagnetic radiation path between said source and said diffuser when said assay device is received within said receiving means.

2. An assay result reader according to claim 1, wherein said electromagnetic radiation is light.

3. An assay result reader according to claim 2, wherein said light is visible light.

4. An assay result reader according to claim 1, wherein said radiation is pulsed and said one or more sensors are synchronized so that they function only in phase with the pulsed radiation.

5. An assay result reader according to claim 4, wherein said radiation has a pulse frequency of at least about 1 kHz.

6. A test kit comprising an assay result reader according to claim 1, together with said assay device comprising a porous liquid-permeable carrier strip or sheet through the thickness of which electromagnetic radiation is transmissible, said carrier including said detection zone in which an assay result is revealed by specific binding of a detectable material directly or indirectly to a binding agent immobilized in said detection zone.

7. A test kit according to claim 6, wherein said assay result reader includes said receiving means for receiving at least a portion of said device, said portion including said detection zone, to present said detection zone to said reading means comprising said electromagnetic radiation and said one or more sensors located such that upon insertion of said device into said receiving means, electromagnetic radiation can be passed through said device and the intensity of electromagnetic radiation emerging from said device can be detected by said one or more sensors.

8. A test kit as claimed in claim 7, wherein said receiving means incorporates interlocking means engageable with corresponding interlocking means on said device to ensure that upon receipt of said device by said reader said at least one detection zone is located and maintained in a predetermined spatial relationship relative to said reading means.

9. A test kit as claimed in claim 8, wherein said receiving means includes actuating means triggered by said receipt of said device, said actuating means causing said reading of said at least one detection zone to be initiated.

10. A test kit according to claim 6, wherein said electromagnetic radiation is light.

11. A test kit according to claim 10, wherein said light is visible light.

12. A test kit as claimed in claim 6, wherein said detectable material comprises a particulate direct label.

13. A test kit as claimed in claim 12, wherein said electromagnetic radiation is visible light of a wavelength that is strongly absorbed by said particulate direct label.

14. A test kit according to claim 6, wherein said assay device is one of a plurality of identical such devices provided as part of the kit.

15. A test kit comprising an assay result reader together with an assay device comprising a porous liquid-permeable carrier in the form of a strip or sheet through the thickness of which electromagnetic radiation is transmissible, said carrier including a detection zone in which an assay result is revealed by specific binding of a detectable material directly or indirectly to a binding agent immobilized in said detection zone, detection of said detectable material being effected by determining the extent to which electromagnetic radiation transmitted through the thickness of said carrier is attenuated by the presence of said detectable material bound in said detection zone, said assay result reader comprising:

a) receiving means for receiving at least a portion of said assay device, said portion including said detection zone;

b) reading means associated with said receiving means, said reading means comprising;

(i) at least one source of electromagnetic radiation; and

(ii) one or more sensors capable of detecting the intensity of said electromagnetic radiation, said source and said one or more sensors being positioned such that when said portion of said assay device is received within said receiving means, said detection zone is disposed in the electromagnetic radiation path between said source and said one or more sensors; and

(iii) a diffuser in front of said one or more sensors such that electromagnetic radiation from said source must pass through said diffuser before reaching said one or more sensors said detection zone of said assay device being disposed in the electromagnetic radiation path between said source and said diffuser when said assay device is received within said receiving means and

wherein said carrier of said assay device is within a casing or cover forming part of said assay device, and said casing or cover having electromagnetic energy transmitting regions enabling electromagnetic radiation to be passed through said device, said detection zone lying in the electromagnetic radiation path between said transmitting regions.

16. A test kit as claimed in claim 15, wherein said device casing or cover includes internal registration means which engages with corresponding registration means associated with said carrier such that said detection zone within said device casing or cover is located in a predetermined spatial relationship relative to interlocking means on said device casing or cover.

17. A test kit according to claim 16, wherein said internal registration means comprises a pin or the like, engageable with a hole or indentation in said carrier, said detection zone being at a predetermined location on said carrier relative to said hole or indentation.

18. A test kit according to claim 15, wherein said electromagnetic radiation from said source is pulsed.

19. A test kit comprising an assay result reader together with an assay device comprising a porous liquid-permeable carrier in the form of a strip or sheet through the thickness of which electromagnetic radiation is transmissible, said carrier including a detection zone in which an assay result is revealed by specific binding of a detectable material directly or indirectly to a binding agent immobilized in said detection zone, detection of said detectable material being effected by determining the extent to which electromagnetic radiation transmitted through the thickness of said carrier is attenuated by the presence of said detectable material bound in said detection zone, said assay result reader comprising:

a) receiving means for receiving at least a portion of said assay device, said portion including said detection zone;

b) reading means associated with said receiving means, said reading means comprising;

(i) at least one source of diffuse electromagnetic radiation; and

(ii) one or more sensors capable of detecting the intensity of said electromagnetic radiation, said source and said one or more sensors being positioned such that when said portion of said assay device is received within said receiving means, said detection zone is disposed in the electromagnetic radiation path between said source and said one or more sensors; and

(iii) a diffuser in front of said one or more sensors such that electromagnetic radiation from said source must pass through said diffuser before reaching said one or more sensors, said detection zone of said assay device being disposed in the electromagnetic radiation path between said source and said diffuser when said assay device is received within said receiving means

wherein said carrier strip or sheet comprises nitrocellulose having a thickness not exceeding 1 mm.