INDICATING STATUS OF A DIAGNOSTIC TEST SYSTEM

• US 20070185679A1
• Filed: 12/05/2006
• Published: 08/09/2007
• Est. Priority Date: 04/01/2004
• Status: Abandoned Application

• Current Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Inventors: Wilson, Robert E., Yi, Robert, Petruno, Patrick T.
• Application Number:
  US11/567,156
• Publication Number:
  US 20070185679A1
• Time in Patent Office: Days
• US Class Current: 702/117
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• 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

Systems and methods of indicating status of a diagnostic test system are described. In one aspect, a diagnostic test system includes a housing, an indicator system, and a test unit in the housing. The indicator system produces a non-textual sensory output signal that is perceptible from an area outside the housing. The test unit performs at least one diagnostic test on a diagnostic assay to determine whether at least one analyte is present within a sample. The test unit also produces a status indicator control signal triggering the indicator system to indicate a status of the diagnostic test via the non-textual sensory output signal.

Claims

1. A diagnostic test system, comprising:

a housing;

an indicator system operable to produce a non-textual sensory output signal perceptible from an area outside the housing; and

a test unit in the housing operable to perform at least one diagnostic test on a diagnostic assay to determine whether at least one analyte is present within a sample and to produce a status indicator control signal triggering the indicator system to indicate a status of the diagnostic test via the non-textual sensory output signal.

2. The diagnostic test system of claim 1, further comprising a light emitting diode operable to produce light in response to the status indicator control signal.

3. The diagnostic test system of claim 2, wherein the light emitting diode is located on an external surface of the housing.

4. The diagnostic test system of claim 2, wherein the light emitting diode produces the non-textual sensory output signal and produces light that illuminates the sample during at least a portion of the diagnostic test.

5. The diagnostic test system of claim 2, wherein the housing contains the test unit and the light emitting diode, at least a portion of the housing is translucent, and the non-textual sensory output signal corresponds to light produced by the light emitting diode and output through the translucent portion of the housing.

6. The diagnostic test system of claim 2, wherein the test unit also is operable to produce a test control signal triggering the light emitting diode to illuminate the sample during at least a portion of the diagnostic test.

7. The diagnostic test system of claim 2, further comprising at least one additional light emitting diodes each operable to produce light in response to the status indicator control signal.

8. The diagnostic test system of claim 1, further comprising an audio transducer operable to produce an audible signal in response to the status indicator control signal.

9. The diagnostic test system of claim 1, further comprising a mechanical vibrator operable to produce a vibrational signal in response to the status indicator control signal.

10. The diagnostic test system of claim 1, wherein the test unit is operable to generate status indicator control signal in response to a determination that the diagnostic test is complete.

11. The diagnostic test system of claim 10, wherein the test unit generates the status indicator control signal in response to a determination that light intensity measured from a measurement region of a lateral flow assay test strip exceeds a threshold light intensity level.

12. The diagnostic test system of claim 1, wherein the test unit is operable to generate the status indicator control signal in response to a determination that the diagnostic test is in progress.

13. The diagnostic test system of claim 1, wherein the test unit is operable to generate the status indicator control signal in response to a determination that the test unit is ready to perform the diagnostic test.

14. The diagnostic test system of claim 1, wherein:

the housing comprises an interface that receives a diagnostic assay test strip that supports lateral flow of a fluid sample, includes a labeling zone containing ones or more labeling substances that bind labels to the one or more analytes, and includes a detection zone comprising at least one test region containing an immobilized substance that binds the one or more analytes, wherein the detection zone includes an area that is exposed for optical inspection; and

the test unit comprises a reader configured to obtain light intensity measurements from the exposed area of the detection zone when the diagnostic assay test strip is loaded in the interface.

15. The diagnostic test system of claim 1, further comprising a disabling unit that is configured to disable the test unit in response to a determination that the current lifetime of the test unit has expired.

16. The diagnostic test system of claim 1, wherein the test unit is free of any mechanism for controlling the indicator system to indicate a result of the diagnostic test.

17. A diagnostic test system, comprising:

housing means;

indicator means for producing a non-textual sensory output signal perceptible from an area outside the housing; and

in the housing means, test unit means for performing at least one diagnostic test on a diagnostic assay to determine whether at least one analyte is present within a sample and for producing status indicator control signal means for triggering the indicator system to indicate a status of the diagnostic test via the non-textual sensory output signal.

18. A diagnostic test method, comprising:

within a housing performing at least one diagnostic test on a diagnostic assay to determine whether at least one analyte is present within a sample; and

producing a non-textual sensory output signal perceptible from an area outside the housing and indicative of a status of the diagnostic test.

19. The diagnostic test method of claim 18, wherein the producing comprises generating the non-textual sensory output signal in response to a determination that the diagnostic test is complete.

20. The diagnostic test method of claim 19, wherein the producing comprises generating the non-textual sensory output signal in response to a determination that light intensity measured from a measurement region of a lateral flow assay test strip exceeds a threshold light intensity level.

21. The diagnostic test method of claim 18, wherein the producing comprises generating the non-textual sensory output signal in response to at least one of a determination that the diagnostic test is in progress and a determination that the test unit is ready to perform the diagnostic test.

22. The diagnostic test method of claim 18, wherein the producing comprises operating a light emitting diode to produce the non-textual sensory output signal from, and further comprising operating the light emitting diode to produce light that illuminates the sample during at least a portion of the diagnostic test.