Disposable electronic assay device

• US 5,580,794 A
• Filed: 05/31/1995
• Issued: 12/03/1996
• Est. Priority Date: 08/24/1993
• Status: Expired due to Term

• Current Assignee: Polymer Technology Systems Incorporated (Sinocare, Inc.)
• Original Assignee: Metrika, Inc. (Bayer AG)
• Inventors: Allen, Michael P.
• Primary Examiner(s): SNAY, JEFFREY R
• Application Number:
  US08/455,236
• Time in Patent Office: 552 Days
• Field of Search: 422/56, 422/58, 422/82.05, 422/82.08, 422/82.09, 364/497, 364/499, 436/169, 436/170
• US Class Current: 436/169
• CPC Class Codes: B01L 2200/10 Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2200/148 Specific details about calibrations
• CPC Class Codes: B01L 2300/024 Storing results with means integrated into the container
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0816 Cards, e.g. flat sample carriers usually with flow in two horizontal directions
• 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 2021/1738 Optionally different kinds of measurements; Method being valid for different kinds of measurement
• CPC Class Codes: G01N 21/77 by observing the effect on a chemical indicator
• 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 2201/0623 Use of a reference LED
• CPC Class Codes: G01N 33/5438 Electrodes
• 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

Abstract

A disposable electronic assay device comprising card-like housing containing a sample receptor for receiving a sample of body fluid containing an analyte to be determined, a sample treatment element for reaction with sample fluid components to yield a physically detectable change which correlates with the amount of analyte in the sample, a detector responsive to the physically detectable change for producing an electrical signal which correlates with the amount of analyte in the sample, a signal processor connected to the detector for converting the electrical signal to a digital test result output, and visually readable output means connected to the signal processor for receiving and presenting the test result output. The signal processor can include an analog to digital conversion element for converting an analog reflectance or transmission output signal to a digital reflectance output, processor for converting the digital reflectance or transmission output to a digital test result output. The sample treatment element can include, for example, in fluid communication, a separator for separating interfering substances from the sample, a sample developer for converting the analyte in the sample to a physically detectable substance in an amount which correlates with the amount of the analyte. The sample development element can comprise bibulous material having a sample reaction zone containing reaction chemistry for reacting specifically with the analyte and producing a product with a physically detectable label, the amount of which correlate with the amount of analyte, and a detection zone positioned for interaction with the detector.

Claims

1. A single-use assay device comprising:

a unitary housing having an exterior surface and sealing an interior area;

sample receptor means for receiving a sample containing an analyte selected for determining its presence, the sample receptor means being located on the exterior surface of the housing;

sample treatment means for reacting the sample with a self-contained reagent to yield a physically detectable change which correlates with the amount of selected analyte in the sample, the sample treatment means being sealed within the housing and in fluid communication with the sample receptor means;

detector means for responding to the physically detectable change and producing an electrical signal which correlates to the amount of the selected analyte in the sample, the detector means being sealed within the housing and in electrical or optical communication with the sample treatment means;

processing means for storing assay calibration information, the assay calibration information being uniquely characteristic to the specific self-contained reagent and physically detectable change of the sample treatment means and to the specific detector means of the individual assay device, the processing means further calibrating the sample treatment means and the detector means using the stored assay calibration information, and the processing means further converting the electrical signal to a digital output, the processing means being sealed within the housing and connected to the detector means; and

display means for visually displaying the digital output external to the housing, the display means being connected to the processing means.

2. The assay device of claim 1 wherein the processing means further calibrates the detector means to a reference standard using the stored assay calibration information.

3. The assay device of claim 1 wherein the processing means further receives the ambient temperature of the assay device from a sensor within the housing and adjusts the assay results using the stored assay calibration information.

4. The assay device of claim 1 wherein the processing means further compares the stored assay calibration information with the electrical signal to determine the accuracy of the assay, the stored assay calibration information including a pre-determined range for the electrical signal.

5. The assay device of claim 1 wherein the processing means further compares the stored assay calibration information with the digital output to determine the accuracy of the assay, the stored assay calibration information including a pre-determined range for the digital output.

6. The assay device of claim 1 wherein the processing means further includes a timer which measures shelf-life of the device and, after a pre-determined period, sends a warning message as the digital output signal to the display means or disables the device.

7. The assay device of claim 1 wherein the sample receptor means includes a sensor for determining the presence of the sample and sending a signal to the processing means, the processing means further clocks the signal and compares the clocked signal to the stored assay calibration information to determine the accuracy of the assay, the stored assay calibration information including a pre-determined range for the clocked signal.

15. The single-use assay device of claim 4 wherein said light source consists of a single light emitting diode and light piping communicating the light emitting diode with the detection zone.

8. A single-use assay device comprising:

a unitary housing having an exterior surface and sealing an interior area;

sample receptor means for receiving a sample containing an analyte selected for determining its presence, the sample receptor means being located on the exterior surface of the housing, the sample receptor means including a reference-on sensor for determining the presence of the sample and sending a reference-on signal to a processing means;

sample treatment means for reacting the sample with a self-contained reagent to yield a physically detectable change which correlates with the amount of selected analyte in the sample, the sample treatment means being sealed within the housing and in fluid communication with the sample receptor means, the sample treatment means including a read-on sensor for determining the presence of the sample and sending a read-on signal to the processing means;

detector means for responding to the physically detectable change and producing an electrical signal which correlates to the amount of the selected analyte in the sample, the detector means being sealed within the housing and in electrical or optical communication with the sample treatment means;

processing means storing assay calibration information, the assay calibration information being uniquely characteristic to the specific self-contained reagent and physically detectable change of the sample treatment means and to the specific detector means of the individual assay device, the processing means further calibrating the sample treatment means and the detector means using the stored assay calibration information, and the processing means further converting the electrical signal to a digital output, the processing means being sealed within the housing and connected to the detector means, the processing means further monitoring the reference-on and read-on signals and comparing the signals to the stored assay calibration information to determine that the reaction has occurred within a specified time and a specified reaction rate to check the accuracy of the assay, the stored assay calibration information including a pre-determined range for the signals; and

display means for visually displaying the digital output external to the housing, the display means being connected to the processing means.

9. A single-use assay device comprising:

a unitary housing having an exterior surface and sealing an interior area;

sample receptor means for receiving a sample containing an analyte selected for determining its presence, the sample receptor means being located on the exterior surface of the housing;

sample treatment means for chemically reacting the sample with a self-contained reagent in a reaction zone to produce a reaction product mixture, the sample treatment means further transporting at least a portion of the reaction product mixture to a detection zone, the sample treatment means being sealed within the housing and in fluid communication with the sample receptor means;

detector means for responding to a physically detectable change in the detection zone which correlates with the amount of selected analyte in the sample and producing an electrical signal which correlates to the amount of the selected analyte in the sample, the detector means being sealed within the housing and in electrical or optical communication with the sample treatment means;

processing means storing assay calibration information, the assay calibration information being uniquely characteristic to the specific self-contained reagent and physically detectable change of the sample treatment means and to the specific detector means of the individual assay device, the processing means further calibrating the sample treatment means and the detector means using the stored assay calibration information, and the processing means further converting the electrical signal to a digital output, the processing means being sealed within the housing and connected to the detector means; and

display means for visually displaying the digital output external to the housing, the display means being connected to the processing means.

10. The single-use assay device of claim 9 wherein the portion of the reaction mixture which is transported to the detection zone includes a reaction product with a physically detectable label which correlates with the amount of the selected analyte in the sample.

11. The single-use assay device of claim 9 wherein the portion of the reaction mixture which is transported to the detection zone includes the sample with undesired substances removed, the sample reacting with a second self-contained reagent in the detection zone to produce a reaction product with a physically detectable label which correlates with the amount of selected analyte in the sample.

12. The single-use assay device of claim 9 wherein the device further includes a power source in electrical connection with the detector means and the processing means, the power source sealed within the housing.

13. The single-use assay device of claim 9 wherein the device further includes a power source in electrical connection with the detector means and the processing means, the power source is a solar cell mounted on the exterior of the housing.

14. The single-use assay device of claim 9 wherein the physically detectable label provides a change in reflectance or transmission of the detection zone, and the detector includes a light source positioned to direct light on the detection zone and a light detector positioned to receive light reflected or transmitted by the detection zone to yield a respective reflectance or transmission output signal.

25. A method of determining the presence of one or more selected analytes in a sample, the method comprising the steps of:

introducing the sample to the sample receptor means of the assay device of claim 9,

transporting the sample to the reaction zone within the sealed housing;

chemically reacting the sample with the self-contained reagent to produce a reaction product mixture;

transporting at least a portion of the reaction product mixture to the detection zone;

producing a physically detectable change in the detection zone and an electrical signal which correlates with the amount of the corresponding selected analyte in the sample;

calibrating the physically detectable change using said stored assay calibration information uniquely characteristic to the specific self-contained reagent and physically detectable change of the individual sealed housing;

converting the electrical signal to a digital output;

displaying the digital output; and

disposing of the sealed housing after one introduction of the sample.

26. The method of claim 25 wherein, prior to the processing step, the method further includes the step of:

chemically reacting the portion of the reaction mixture transported to the detection zone with a second self-contained reagent to produce a reaction product with a physically detectable label which correlates with the amount of selected analyte in the sample.

27. The method of claim 25 wherein the method further includes the step of calibrating the measuring step to a reference standard using the stored information.

28. The method of claim 25 wherein the method further includes the steps of receiving the ambient temperature of the assay device from a sensor within the housing and adjusting the assay results using the stored information.

29. The method of claim 25 wherein the method further includes the step of comparing the stored information with the electrical signal to determine the accuracy of the assay, the stored information including a pre-determined range for the electrical signal.

30. The method of claim 25 wherein the method further includes the step of comparing the stored information with the digital output to determine the accuracy of the assay, the stored information including a pre-determined range for the digital output.

31. The method of claim 25 wherein the method further includes the steps of timing the presence of the sample and comparing the timed presence of the sample to the stored information to determine the accuracy of the assay, the stored information including a pre-determined range for the timed presence of the sample.

16. A single-use device for performing a plurality of assays, the multi-assay device comprising:

a unitary housing having an exterior surface and sealing an interior area;

sample receptor means for receiving a sample containing at least one of a plurality of analytes selected for determining its presence, the sample receptor means being located on the exterior surface of the housing;

sample treatment means for chemically reacting the sample with a plurality of self-contained reagents corresponding to the plurality of assays, each self-contained reagent chemically reacting with the sample in a corresponding reaction zone located on a transport matrix to produce a reaction product mixture corresponding to each self-contained reagent, the sample treatment means further transporting at least a portion of each reaction product mixture to a corresponding detection zone located on the transport matrix, the sample treatment means being sealed within the housing and in fluid communication with the sample receptor means;

detector means for responding to a physically detectable change in each detection zone which correlates with the amount of selected analyte in the sample and producing a corresponding electrical signal which correlates to the amount of the selected analyte in the sample, the detector means being sealed within the housing and in electrical or optical communication with the sample treatment means;

processing means storing assay calibration information, the assay calibration information being uniquely characteristic to each specific self-contained reagent and each specific physically detectable change of the sample treatment means and to the specific detector means of the individual multi-assay device, the processing means further calibrating the sample treatment means and the detector means using the stored assay calibration information, and the processing means further connected to the detector means for converting each electrical signal to a corresponding digital output, the processing means being sealed within the housing;

display means for visually displaying each digital output external to the housing, the display means being connected to the processing means.

17. The multi-assay device of claim 16 wherein the portion of each reaction mixture which is transported to the corresponding detection zone includes a reaction product with a physically detectable label which correlates with the amount of the corresponding selected analyte in the sample.

18. The multi-assay device of claim 16 wherein the portion of each reaction mixture which is transported to the corresponding detection zone includes the sample with undesired substances removed, the sample chemically reacting with a second plurality of self-contained reagents in each corresponding detection zone to produce a reaction product with a physically detectable label which correlates with the amount of the corresponding selected analyte in the sample.

19. The multi-assay device of claim 16 wherein the sample contains more than one analyte selected for determining its presence, each self-contained reagent corresponds to one of the selected analytes.

20. The multi-assay device of claim 16 wherein each physically detectable change provides a change in reflectance or transmission of each detection zone, and the detector means includes a light source positioned to direct light on each detection zone and a light detector positioned to receive light reflected or transmitted by each detection zone to yield a respective reflectance or transmission output signal corresponding to each physically detectable change.

21. The multi-assay device of claim 16 wherein the light source includes a single light emitting diode and light piping connecting the light emitting diode to each detection zone.

22. A single-use device for performing a plurality of assays, the multi-assay device comprising:

a unitary housing having an exterior surface and sealing an interior area;

sample receptor means for receiving a sample containing at least one of a plurality of analytes selected for determining its presence, the sample receptor means being located on the exterior surface of the housing;

sample treatment means for reacting the sample with a plurality of self-contained reagents corresponding to the plurality of assays, each self-contained reagent reacting with the sample in a corresponding reaction zone located on a transport matrix to produce a reaction product mixture corresponding to each self-contained reagent, the sample treatment means further transporting a portion of each reaction product mixture to a corresponding detection zone located on the transport matrix, the sample treatment means being sealed within the housing and in fluid communication with the sample receptor means;

detector means for responding to a physically detectable change in each detection zone which correlates with the amount of the corresponding selected analyte in the sample and producing a corresponding electrical signal which correlates to the amount of the corresponding selected analyte in the sample, the detector means being sealed within the housing and in electrical or optical communication with the sample treatment means;

processing means storing assay calibration information, the assay calibration information being uniquely characteristic to each specific self-contained reagent and to each specific physically detectable change of the sample treatment means and to the specific detector means of the individual assay device, the processing means further calibrating the sample treatment means and the detector means using the stored assay calibration information, and the processing means further converting each electrical signal to a corresponding digital output, the processing means being sealed within the housing and connected to the detector means;

a power source in electrical connection with the detector means and the processing means, the power source sealed within the housing; and

display means for visually displaying each digital output external to the housing, the display means being connected to the processing means.

23. The multi-assay device of claim 22 wherein the portion of each reaction mixture which is transported to the corresponding detection zone includes a reaction product with a physically detectable label which correlates with the amount of the corresponding selected analyte in the sample.

24. The multi-assay device of claim 22 wherein the portion of each reaction mixture which is transported to the corresponding detection zone includes the sample with undesired substances removed, the sample chemically reacting with a second plurality of self-contained reagents in each corresponding detection zone to produce a reaction product with a physically detectable label which correlates with the amount of the corresponding selected analyte in the sample.