Early determination of assay results

• US 7,239,394 B2
• Filed: 12/19/2003
• Issued: 07/03/2007
• Est. Priority Date: 06/04/2003
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Inverness Medical Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Sharrock, Stephen Paul, Phelan, Andrew Peter
• Primary Examiner(s): Toatley, Jr.; Gregory J.
• Assistant Examiner(s): Geisel; Kara
• Application Number:
  US10/741,416
• Publication Number:
  US 20050037510A1
• Time in Patent Office: 1,292 Days
• Field of Search: 356/436, 356/39, 204/403.01, 204/403.03
• US Class Current: 356/436
• CPC Class Codes: G01N 2021/7759 Dipstick; Test strip
• CPC Class Codes: G01N 2021/7773 Reflection
• CPC Class Codes: G01N 2021/8488 the band presenting reference patches
• CPC Class Codes: G01N 2021/8494 Measuring or storing parameters of the band
• CPC Class Codes: G01N 21/00 Investigating or analysing materials by the use of optical means, i.e. using sub-millimetre waves, infrared, visible or ultraviolet light G01N3/00 - G01N19/00 take precedence
• CPC Class Codes: G01N 21/05 Flow-through cuvettes G01N21/09 takes precedence; handling fluid samples G01N1/10
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/4738 Diffuse reflection precedence is given to G01N21/55 - G01N21/57 if specular component is taken into consideration, e.g. also for testing fluids, fibrous materials
• CPC Class Codes: G01N 21/55 Specular reflectivity
• CPC Class Codes: G01N 21/78 producing a change of colour
• 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 2201/06106 Plural sources used for calibration
• CPC Class Codes: G01N 2201/062 LED's
• CPC Class Codes: G01N 31/22 using chemical indicators G01N31/02 takes precedence

Abstract

A device for determining the result of an assay may include a computation circuit, responsive to a signal representing the amount of an analyte or the rate of accumulation of an analyte, to: compare the signal to a first threshold; compare the signal to a second threshold, the second threshold being less than the first threshold; generate an output signal if the signal exceeds the first threshold or the signal is less than the second threshold, the output signal indicative of a first result if the signal exceeds the first threshold, or, alternatively, the output signal indicative of a second result if the signal is less than the second threshold; and terminate the assay if the signal exceeds the first threshold or the signal is less than the second threshold.

Claims

1. A device for determining the result of an assay, comprising:

a computation circuit, responsive to a signal representing the amount of an analyte or the rate of accumulation of an analyte, to;

compare the signal to a first threshold;

compare the signal to a second threshold, the second threshold being less than the first threshold;

generate an output signal if the signal exceeds the first threshold or the signal is less than the second threshold, the output signal indicative of a first result if the signal exceeds the first threshold, or, alternatively, the output signal indicative of a second result if the signal is less than the second threshold; and

terminate the assay if the signal exceeds the first threshold or the signal is less than the second threshold.

2. A device according to claim 1, wherein the first result is a positive result, and the second result is a negative result.

3. A device according to claim 1, wherein the computation circuit is further responsive to the signal to repeat the comparisons and the conditional generation if the signal is between the first threshold and the second threshold.

4. A device according to claim 1, further comprising an optical detection system for measuring the signal.

5. A device according to claim 4, wherein the optical detection system comprises at least one light source and at least one photodetector.

6. A device according to claim 4, wherein the optical detection system comprises at least three light sources and two photodetectors.

7. A device according to claim 6, wherein the at least three light sources comprise three light emitting diodes, and the at least two photodetectors comprise two photodiodes.

8. A device according to claim 1, further comprising a timer coupled to the computation circuit.

9. A device according to claim 8, wherein the comparisons are performed within about one second of each other.

10. A device according to claim 8, wherein the comparisons are performed within about 60 seconds of each other.

11. A device according to claim 8, wherein the comparisons are performed at least about 30 seconds apart.

12. A device according to claim 1, further comprising a housing enclosing the computation circuit.

13. A device according to claim 12, wherein the housing is no larger than about 12 cm long, about 2.5 cm wide, and about 2.2 cm tall.

14. A device according to claim 12, further comprising at least one light source and at least one photodetector, and wherein:

the housing defines an aperture for receiving at least a portion of a test strip inside the device, the assay strip having at least one zone, and

the aperture, the light source, and the photodetector are positioned, sized and shaped so that, upon insertion of the test strip, light emitted from the light source is incident on the zone, and light emanating from the zone is incident on the photodetector, and wherein the photodetector generates a signal representing an amount of an analyte in the zone.

15. A device according to claim 14, wherein the housing is no larger than about 12 cm long, about 2.5 cm wide, and about 2.2 cm tall.

16. A device according to claim 14, wherein the at least one light source comprises three light sources, and the at least one photodetector comprises two photodetectors.

17. A device according to claim 16, wherein the at least three light sources comprise three light emitting diodes, and the at least two photodetectors comprise two photodiodes.

18. A device accordingly to claim 1, further comprising at least one light source, at least one photodetector, and a test strip having at least one zone, wherein the light source, the photodetector, and the test strip are positioned, sized and shaped so that light emitted from the light source is incident on the zone, and light emanating from the zone is incident on the photodetector, and wherein the photodetector generates a signal representing an amount of an analyte in the zone.

19. A device according to claim 18, wherein the at least three light sources comprise three light emitting diodes, and the at least two photodetectors comprise two photodiodes.

20. A device according to claim 1, further comprising a memory system for storing assay results.

21. A device according to claim 1, wherein the computation circuit is further responsive to the signal to adjust one or both threshold values.

22. An assay result reading device for reading the result of an assay to detect the presence and/or amount of an analyte of interest and wherein the presence or absence, as appropriate, of the analyte of interest causes a reaction which leads to the accumulation of a signal in a time-dependent manner, the device comprising:

means for determining the rate or amount of signal accumulation;

means for comparing the determined rate or amount of signal accumulation with an upper threshold value;

means for comparing the determined rate or amount of signal accumulation with a lower threshold value; and

means for declaring the result of the assay if the determined rate or amount of signal accumulation exceeds the upper threshold value or is below the lower threshold value or at such time when it is determined that the rate or amount of signal accumulation will not exceed or is not likely to exceed the lower threshold value before the assay has been completed.

23. A method for determining a result of an assay, comprising:

performing the assay to generate a signal representing the amount of an analyte or the rate of accumulation of an analyte;

comparing the signal with a first threshold value before the assay reaches equilibrium;

comparing the signal with a second threshold value before the assay reaches equilibrium; and

declaring the result of the assay if the determined rate or amount of signal accumulation exceeds the first threshold value or is below the second threshold value.

24. A method of declaring the result or outcome of an assay to detect the presence and/or amount of an analyte of interest, the method comprising:

performing the assay so as to cause the reaction which leads to the accumulation of a signal in a time-dependent manner;

determining, before the reaction has reached equilibrium, the rate or amount of signal accumulation;

comparing the determined rate or amount with an upper and a lower threshold value; and

declaring the result or outcome of the assay if the determined rate or amount of signal accumulation exceeds the upper threshold value or is below the lower threshold value or at such time when it is determined that the rate or amount of signal accumulation will not exceed or is not likely to exceed the lower threshold value before the assay has been completed.

25. A method according to claim 24, further comprising the step of defining at least an upper and lower threshold value.

26. A device for determining an assay result, comprising:

a computation circuit, responsive to a signal representing the amount of an analyte or the rate of accumulation of an analyte before the assay reaches equilibrium, to;

compare the signal to a first threshold;

compare the signal to a second threshold, the second threshold being less than the first threshold; and

generate an output signal if the signal exceeds the first threshold or the signal is less than the second threshold, the output signal indicative of a first result if the signal exceeds the first threshold, or, alternatively, the output signal indicative of a second result if the signal is less than the second threshold.

27. A method comprising:

performing an assay;

before the assay has reached equilibrium, generating a signal representing the amount of an analyte or the rate of accumulation of an analyte;

comparing the signal with a first threshold value;

comparing the signal with a second threshold value; and

declaring a result of the assay if the determined rate or amount of signal accumulation exceeds the first threshold value or is below the second threshold value.