Assay test system for regulating temperature

• US 7,285,425 B2
• Filed: 05/14/2002
• Issued: 10/23/2007
• Est. Priority Date: 05/14/2002
• Status: Expired due to Fees

• Current Assignee: Siemens Healthcare Diagnostics Incorporated (Siemens AG)
• Original Assignee: Siemens Medical Solutions Diagnostics (Siemens AG)
• Inventors: Albarella, James P., Smous, James E., Shareef, Nazeer H.
• Primary Examiner(s): Chin; Christopher L.
• Application Number:
  US10/475,871
• Publication Number:
  US 20040115832A1
• Time in Patent Office: 1,988 Days
• Field of Search: None
• US Class Current: 436/514
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/1805 Conductive heating, heat from thermostatted solids is conducted to receptacles, e.g. heating plates, blocks
• CPC Class Codes: B01L 2300/1844 using fans
• CPC Class Codes: B01L 3/5023 with a sample being transported to, and subsequently stored in an absorbent for analysis
• CPC Class Codes: G01N 2035/00346 Heating or cooling arrangements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: Y10S 435/805 Test papers
• 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 436/81 Tube, bottle, or dipstick

Abstract

A device for evaluating at least one analyte in a test sample. The device comprises a cassette having a hollow test chamber, a test strip disposed within the test chamber for receiving the test sample, and a temperature control member. The cassette has at least one aperture extending from an exterior of the cassette to the hollow test chamber. The test strip includes a reagent adapted to react with the at least one analyte to produce a reaction indicative of the presence of the analyte. The temperature control member is adapted to extend through the at least one aperture in the cassette and into the test chamber for controlling the temperature of the test chamber.

Claims

1. A device for evaluating at least one analyte in a test sample, the device comprising:

a disposable cassette having a hollow test chamber and at least one aperture extending from an exterior of the cassette to the hollow test chamber;

a test strip disposed within the test chamber for receiving the test sample, the test strip including a reagent for reacting with the at least one analyte to produce a reaction indicative of the presence of the analyte; and

a temperature control member comprising at least one fin positioned adjacent to, but not in direct contact with, said test strip and extending through the at least one aperture in the cassette and into the test chamber for controlling the temperature of the test chamber, and a thermoelectric temperature control unit in thermal communication with the at least one fin for controlling the temperature of the test chamber.

2. The device of claim 1 wherein the test strip comprises an immunochromatographic test strip.

3. The device of claim 1 wherein the test strip is made out of a bibulous material.

4. The device of claim 1 wherein the cassette top and the cassette bottom are made of plastic.

5. The device of claim 1 wherein the at least one fin comprises a plurality of fins, and wherein the at least one aperture of the cassette comprises a plurality of apertures, each of the plurality of apertures for receiving one or more of the plurality of fins, one or more of the plurality of fins extending through each of the plurality of apertures into the test chamber.

6. The device of claim 5 wherein the temperature control member further comprises a fixture plate attached to the plurality of fins, and wherein the fixture plate and the plurality of fins are integrally formed.

7. The device of claim 6 wherein the fixture plate and the plurality of fins are made out of a thermally conductive material.

8. The device of claim 7 wherein the thermally conductive material is aluminum.

9. The device of claim 1 in combination with a spectrometer for reading the reaction indicative of the presence of the analyte.

10. An apparatus for controlling the temperature of an assay test strip, the apparatus comprising:

a cassette carrier for receiving a disposable test cassette having at least one aperture;

a thermally conductive member extending through the at least one aperture of a test cassette received by the cassette carrier and positioned adjacent to, but not in direct contact with, said test strip; and

a temperature control unit in thermal communication with the thermally conductive member for controlling the temperature of said cassette carrier.

11. The apparatus of claim 10 wherein the thermally conductive member is made of aluminum.

12. The apparatus of claim 10 wherein the thermally conductive member comprises at least one fin fixedly attached to a fixture plate.

13. The apparatus of claim 12 wherein the fixture plate and at least one fin are integrally formed.

14. The apparatus of claim 12 wherein the at least one fin comprises two or more fins.

15. The apparatus of claim 12 wherein the material is a thermally conductive material.

16. The apparatus of claim 12 wherein the temperature control unit comprises a thermoelectric device.

17. The apparatus of claim 16 wherein the thermoelectric device is a Peltier Effect thermoelectric device.

18. A method for evaluating at least one analyte in a test sample, the method comprising:

providing a disposable test cassette having at least one aperture;

disposing a test strip within a test chamber of the test cassette, the test strip including a reagent for reacting with the at least one analyte to produce a reaction indicative of the presence of the analyte;

applying the test sample to the test strip;

controlling the temperature of the test chamber with a temperature control member in thermal communication with a thermoelectric temperature control unit extending through the at least one aperture formed in the test cassette, said temperature control member comprising at least one fin positioned adjacent to, but not in direct contact with, said test strip; and

evaluating said analyte in said test sample by reading said reaction indicative of said analyte.

19. The method of claim 18 further comprising detecting any change in the test strip.

20. The method of claim 18 wherein the test strip comprises an immunochromatographic test strip.

21. The method of claim 18 further comprising forming the test cassette from a cassette top and a cassette bottom.

22. The method of claim 18 wherein the temperature control member includes a fixture plate attached to the at least one fin, and wherein the fixture plate and the at least one fin are integrally formed.

23. The method of claim 22 wherein the fixture plate and the at least one fin are made out of a thermally conductive material.

24. A device for evaluating at least one analyte is a test sample, the device comprising:

a disposable cassette having a hollow test chamber and at least one aperture extending from an exterior of the cassettes to the hollow test chamber;

a test strip disposed within the test chamber for receiving the test sample, the test strip including a reagent for reacting with the at least one analyte to produce a reaction indicative of the presence of the analyte; and

a temperature control member comprising at least one resistive heating element, said temperature control member controlling the temperature in said cassette by the current supplied to said at least one resistive heating element.

25. The device of claim 24 wherein the at least one resistive heating element comprises a plurality of resistive heating elements, and wherein the at least one aperture of the cassette comprises a plurality of apertures, each of the plurality of apertures receiving one or more of the plurality of resistive heating elements, one or more of the plurality of resistive heating elements extending through each of the plurality of apertures into the test chamber.

26. The device of claim 24 further comprising a circuit for controlling the amount of current supplied to the at least one resistive heating element.

27. A method for evaluating at least one analyte in a test sample, the method comprising:

providing a disposable test cassette having at least one aperture;

disposing a test strip within a test chamber of the test cassette, the test strip including a reagent for reacting with the at least one analyte to produce a reaction indicative of the presence of the analyte;

applying the test sample to the test strip;

controlling the temperature of the test chamber with a temperature control member extending through the at least aperture formed in the test cassette, said temperature control member including at least one resistive heating element, the temperature of said at least one resistive heating element controlled by current supplied to said at least one resistive heating element; and

evaluating said analyte in the test sample by reading said reaction indicative of said sample.

28. The method of claim 27 wherein controlling further comprises controlling the amount of electrical current that passes through the at least one resistive heating element.