Electronic assay device and method

• US 5,837,546 A
• Filed: 06/07/1996
• Issued: 11/17/1998
• 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: Widunas, Joseph T., Allen, Michael P., Blatt, Joel M.
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US08/657,894
• Time in Patent Office: 893 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 2400/0406 capillary forces
• 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 33/5438 Electrodes

Abstract

The present invention provides an assay device for determining the presence of one or more selected analytes in a sample. The device includes a housing having an exterior surface and defining an interior area. A sample receptor receives the sample. A sample treatment strip reacts the sample with a reagent to yield a physically detectable change which correlates with the amount of selected analyte in the sample. A detector responds to the physically detectable change and produces an electrical signal which correlates to the amount of the selected analyte in the sample. A processor converts the electrical signal to a digital output. A starter automatically activates the processor and detector upon the application of the sample to the device. A display visually displays the digital output external to the housing and is connected to the processor. The present invention also provides a method for determining the presence of one or more selected analytes in a sample within a disposable housing, automatically starting a diagnostic device to analyze a sample, and displaying quantitative assay results for a plurality of selected analytes in a sample on a diagnostic device.

Claims

1. An assay device for determining the presence of one or more selected analytes in a sample, the device comprising:

a housing having an exterior surface and defining an interior area;

sample receptor means for receiving a sample, the sample receptor means being located on the exterior surface of the housing;

sample treatment means for reacting the sample with a reagent to yield a physically detectable change which correlates with the amount of selected analyte in the sample, the sample treatment means being located 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 selected analyte in the sample, the detector means being located 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 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 located within the housing and connected to the detector means;

starting means for automatically activating the processing means and detector means upon the application of the sample to the device, the starting means being located within the housing and connecting to the processing 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 starting means includes a sensor positioned within the housing and in fluid communication with the sample, the sensor contacts the sample prior to the physically detectable change from reacting the sample with the reagent being produced, the sensor generates a signal upon contact with the sample, and the signal is transmitted to the processing means.

3. The assay device of claim 2 wherein the sensor includes two electrodes spaced apart from one another and in fluid communication with the sample, at least one of the electrodes being electrically connected to the processing means.

4. The assay device of claim 3 wherein the starting means further includes electrically connecting one electrode to a power supply and the processing means, the other electrode is electrically connected to a ground, each of the electrodes is made of a different metal so that an electrical potential is created therebetween upon contact of the electrodes with the sample to create a voltage transition which is signaled to the processing means.

5. The assay device of claim 1 wherein the starting means is positioned within the sample receptor means in fluid communication with the sample.

6. The assay device of claim 1 wherein the processing means further times the period from activation by the starting means to stabilization of the physically detectable change, and compares the timed period to the stored assay calibration information to determine the accuracy of an assay performed with the device, the stored assay calibration information including a pre-determined range for the timed period.

7. The assay device of claim 1 wherein the detector means further includes producing a reference electrical signal upon activation by the starting means which correlates to the sample treatment means prior to contact with the sample;

and the processing means further includes comparing the reference electrical signal to the electrical signal received from the detector means after stabilization of the physically detectable change.

8. A multi-assay device for determining the presence of a plurality of selected analytes in a sample, the multi-assay device comprising:

a housing having an exterior surface and defining an interior area;

sample receptor means for receiving a sample, the sample receptor means being located on the exterior surface of the housing;

sample treatment means for reacting the sample with a plurality of reagents corresponding to the plurality of selected analytes to yield physically detectable changes which each correlate with the amount of one of the selected analytes in the sample, the sample treatment means being located within the housing and in fluid communication with the sample receptor means;

detector means for responding to the physically detectable changes and producing electrical signals which each correlate to the amount of one of the selected analytes in the sample, the detector means being located 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 reagent and 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 converting each electrical signal to a digital output corresponding to each selected analyte, the processing means being located within the housing and connected to the detector means; and

display means for externally displaying each digital output corresponding to one of the selected analytes, each digital output having assay result information of one of the selected analytes, the display means being connected to the processing means.

9. The multi-assay device of claim 8 wherein the display means further includes a plurality of screens, and for each digital output a first of the plurality of screens visually displays a first component of the digital output having the identity of a selected analyte, and a second of the plurality of screens visually displays the amount of the corresponding selected analyte.

10. The multi-assay device of claim 9 wherein the display means further includes simultaneously displaying the identity and amount of one selected analyte corresponding to one digital output, the processor means cycling each digital output to the display means for a predetermined period of time.

11. An assay device for providing quantitative measurement of one or more selected analytes in a sample using reflected optical radiation, the device comprising:

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

a receptor configured to receive a sample containing an analyte, the receptor being located on the exterior surface of the housing;

at least one assay strip for reacting the sample with a self-contained reagent to yield a physically detectable change in at least one sampling area on each assay strip which correlates with the amount of selected analyte in the sample, each assay strip being in fluid communication with the receptor;

a reflectometer having an optical radiation source, a detector configured to quantitatively detect optical radiation, and an optics assembly configured to direct illumination from the optical radiation source to each sampling area on the at least one assay strip and to direct radiation diffusely reflected from each sampling area to the detector, the detector producing an electrical signal which correlates to the amount of the selected analyte in the sample;

a processor configured to store assay calibration information, the assay calibration information being uniquely characteristic to the specific self-contained reagent and physically detectable change within each sampling area and to the specific reflectometer of the individual assay device, the processor further configured to calibrate each sampling area and the reflectometer using the stored assay calibration information, and the processor further configured to convert each electrical signal to a digital output, the processor being sealed within the housing and connected to the reflectometer;

a starter configured to automatically activate the processor and reflectometer upon the application of the sample to the device, the starter being located within the housing and connecting to the processor; and

a display configured to visually display each digital output external to the housing, the display being connected to the processor.

12. The assay device of claim 11 wherein each assay strip includes at least two sampling areas, the processor further configured to calibrate each assay strip by summing the electrical signal from each sampling area to one another and comparing the sum to the electrical signal of each sampling area or to the stored assay calibration information.

13. The assay device of claim 11 wherein the display is further configured to individually display the digital output from each assay strip in a predetermined cycle.

14. The assay device of claim 11 wherein the device further includes a filter configured to remove contaminants from the sample, the filter is in fluid communication with each assay strip prior to a sampling area.

15. A method of determining the presence of one or more selected analytes in a sample using a disposable housing, the method comprising the steps of:

reacting a sample within the housing with a reagent corresponding to one or more of the selected analytes to yield a physically detectable change which correlates with the amount of the selected analyte in the sample;

calibrating the physically detectable change using assay calibration information uniquely characteristic to the specific reagent in the housing and to the physically detectable change for the selected analyte to determine the amount of the selected analyte; and

displaying the amount of the selected analyte.

16. The method of claim 15 wherein, after the reacting step, the method further includes the steps of:

producing an electrical signal which correlates with the amount of the corresponding selected analyte in the sample;

converting the electrical signal to a digital output;

and the displaying step further includes displaying the digital output.

17. The method of claim 16 wherein the method further includes the step of comparing the calibration information with the electrical signal to determine the accuracy of the method, the calibration information including a pre-determined range for the electrical signal.

18. The method of claim 15 wherein the method further includes the step of storing the assay calibration information within the housing prior to the reacting step.

19. The method of claim 15 wherein the method further includes the step of sealing the housing prior to the reacting step.

20. The method of claim 15 wherein, prior to the calibrating step, the method further includes the step of:

reacting at least a portion of a reaction mixture of the sample and the reagent with a second reagent to produce a reaction product with a physically detectable label which correlates with the amount of selected analyte in the sample.

21. The method of claim 15 wherein the method further includes the step of calibrating the physically detectable change to a reference standard.

22. The method of claim 15 wherein the method further includes the step of adjusting the determined amount of the selected analyte to the ambient temperature of the housing using the calibration information.

23. The method of claim 15 wherein the method further includes the step of comparing the calibration information with the display of the amount of the selected analyte to determine the accuracy of the method, the calibration information including a pre-determined range for the display of the amount of the selected analyte.

24. The method of claim 15 wherein the method further includes the steps of measuring a length of time the sample reacts with the reagent and comparing the timed reaction of the sample to the calibration, information to determine the accuracy of the method, the calibration information including a pre-determined range for the timed reaction of the sample.

25. The method of claim 15 wherein the method further includes the step of starting the method automatically upon introduction of the sample to the housing.

26. The method of claim 15 wherein the method further includes the step of performing the reacting and calibrating steps for each of a plurality of analytes to be determined in the sample;

and the displaying step further includes simultaneously displaying the determined amount of one selected analyte and cycling the display of assay results of each selected analyte for a predetermined period of time.

27. A method of automatically starting a diagnostic device and of determining the presence of one or more selected analytes in a sample, the method comprising the steps of:

sensing the introduction of a sample to a single-use, disposable device and generating a signal to activate the device; and

reacting a self-contained reagent located within the device with one or more selected analytes in the sample to yield a physically detectable change which correlates with assay calibration information stored within the device which is uniquely characteristic to the specific self-contained reagent and physically detectable change.

28. The method of claim 27 wherein the sensing step includes creating an electrical potential between a plurality of electrodes and changing the electrical potential between the electrodes upon contacting the sample with the electrodes.

29. The method of claim 28 wherein the sensing step further includes the steps of:

connecting at least one electrode to a power supply and the device;

connecting at least one other electrode to a ground to create an electrical potential therebetween which changes upon contact of the electrodes with the sample; and

signaling the changing electrical potential to the device.