Recording assay device

• US 20090042313A1
• Filed: 02/13/2008
• Published: 02/12/2009
• Est. Priority Date: 03/19/1997
• Status: Active Grant

• Current Assignee: James Richard Jackson
• Original Assignee: James Richard Jackson
• Inventors: Jackson, James Richard
• Granted Patent: US 7,947,490 B2
• Time in Patent Office: Days
• US Class Current: 436/174
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/5302 Apparatus specially adapted for immunological test procedures
• 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 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10T 436/25 including sample preparation

Abstract

The invention herein described relates to an assessment device comprising an assay part and a detachable recording part. The assessment device facilitates the rapid assaying and processing of tissue/fluid samples by healthcare workers. Also, advantageously, the result of the assay is only apparent to the healthcare worker after interrogation of the recording part at a processing facility.

Claims

1-22. -22. (canceled)

23. An assessment device, comprising:

a substrate irreversibly separable into first and second portions;

an assay element, arranged on the first portion;

a data recording element, arranged on the second portion; and

means for communicating data from the assay element to the recording element, the data communication means arranged onto the substrate.

24. The assessment device of claim 23, further comprising:

means for facilitating irreversible separation of the first and second portions.

25. The assessment device of claim 24, wherein:

the facilitating means comprises a weakening.

26. The assessment device of claim 23, wherein:

the assay element comprises;

a sample application well; and

a detection zone in fluid communication with the sample well; and

material for assaying a fluid sample, contained in the assay element.

27. The assessment device of claim 26, wherein:

the detection zone comprises means for detecting an assay product.

28. The assessment device of claim 23, wherein:

the means for communicating data from the assay element to the recording element comprises an electrical connection.

29. The assessment device according to claim 23, wherein:

the recording element comprises means for electronic downloading and transfer of data to a processing facility.

30. The assessment device according to claim 23, wherein:

the recording element comprises an electronic storage device.

31. The assessment device according to claim 23, wherein:

the recording element comprises a microchip or microprocessor.

32. The assessment device according to claim 23, further comprising:

an indicator actuated on completion of the assay.

33. The assessment device according to claim 23, wherein:

the assay element comprises a further sample application well, the further sample application well containing a material for assaying a fluid sample.

34. The assessment device according to claim 23, wherein:

the assay element comprises a sample application well, the well comprising a surface impregnated with a material for assaying a fluid sample.

35. An assessment device, comprising:

a substrate irreversibly separable into first and second portions;

an assay element, arranged on the first portion, comprising;

a sample application well;

a detection zone in fluid communication with the application well; and

material for assaying a fluid sample, contained in the assay element;

a data recording element comprising an electronic storage device, arranged on the second portion;

the substrate comprises a means for facilitating irreversible separation of the first and second portions; and

an electrical connection between the assay element and the recording element for communicating data from the assay element to the recording element, the electrical connection irreversibly broken when the first and second portions are separated.

36. The assessment device according to claim 35, further comprising:

an indicator actuated on completion of an assay.

37. The assessment device according to claim 35, wherein:

the recording element is provided with data communication control means for electronic downloading and transfer of data to a processing facility.

38. An assessment kit, comprising:

the assessment device according to claim 35; and

protective packaging for transport of the recording element to a processing facility.

39. A method for assaying a biological sample, comprising:

providing an assessment device having an assay element and a data recording element arranged on a substrate;

receiving a sample within a sample application well on the assay element;

mixing the sample with an assay reagent;

detecting assay information relating to said sample;

recording the assay information within the recording element; and

providing a means for irreversibly separating the assay element and the data recording element.

40. The method of claim 39, further comprising the step of:

providing an actuating signal to an indicator upon completion of the assay.