Analytical system with means for detecting too small sample volumes

• US 6,055,060 A
• Filed: 07/16/1997
• Issued: 04/25/2000
• Est. Priority Date: 07/16/1996
• Status: Expired due to Term

• Current Assignee: Roche Diagnostics GmbH (Roche Holding AG)
• Original Assignee: Boehringer Mannheim GmbH (Roche Holding AG)
• Inventors: Eisenbarth, Bernd, Bolduan, Franz, Leininger, Helmut, Miltner, Karl, Thym, Detlef
• Primary Examiner(s): Pham, Hoa Q.
• Application Number:
  US08/895,368
• Time in Patent Office: 1,014 Days
• Field of Search: 356/432, 356/433, 356/434, 356/435, 356/436, 356/445, 356/446, 356/448, 356/39, 356/36, 356/37, 356/427
• US Class Current: 356/433
• CPC Class Codes: G01N 2035/009 alarms, e.g. audible
• 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 35/00029 provided with flat sample substrates, e.g. slides G01N35/028 takes precedence
• CPC Class Codes: G01N 35/00594 Quality control, including calibration or testing of components of the analyser
• CPC Class Codes: G01N 35/00603 Reinspection of samples
• CPC Class Codes: G01N 35/1016 Control of the volume dispensed or introduced

Abstract

Analytical system for evaluating test elements having means of determining whether a sufficient amount of sample liquid was evenly applied to an application zone comprising in a first embodiment of the invention at least two sources of light which illuminate separate or at least not fully overlapping areas of the application zone or the evaluation zone of the test strip, a control unit with which the light sources, of which there at least two, can be independently activated, at least one sensor which detects light reflected by the evaluation zone or transmitted by the evaluation zone and supplies an output signal proportional to the intensity of light as well as an evaluation unit which receives a first output signal from the sensor and converts it into a first measured value when the first of the light sources is activated, receives a second output signal from the sensor and converts it into a second measured value when the second of the light sources, is activated and compares the measured values and determines whether the deviation of the first value measured from the second value measured is sufficiently small. In a second embodiment of an analytical system according to the invention, at least one light source is used to illuminate the sample application zone or the evaluation zone of a test element and at least two sensors detect light reflected or transmitted by the evaluation zone, the output signal of the sensors being converted into measured values by the evaluation unit which determines whether the deviation of the measured values is sufficiently small.

Claims

1. An analytical system for evaluation of test elements, said analytical system determining consistent application of a sufficient amount of sample liquid, said system comprising:

a first light source for illuminating a first illumination area of a sample application area of the test element;

a second light source for illuminating a second illumination area of the sample application area of the test element, said first and second illumination areas being different from each other;

control means coupled to said first and second light sources, said control means for separately controlling light irradiation from said first and second light sources;

sensor means for sensing secondary light after light from said first and second light source impinges upon the test element, said sensor means generating first and second output signals proportional to an intensity of secondary light provided by the first and second light sources, respectively;

evaluation means coupled to said sensor means, said evaluation means receiving the first output signal of the sensor and converting the first output signal to a first measured value when the first light source is activated, said evaluation means receiving the second output signal of the sensor means and converting the second output signal to a second measured value when the second light source is activated, said evaluation means comparing the first and second values and determining a deviation between the measured values, wherein said evaluation means compares the deviation value to a predetermined threshold value to determine consistent application of the sample liquid.

2. An analytical system as recited in claim 1, wherein said secondary light is light which has been transmitted through the first and second illumination areas.

3. An analytical system as recited in claim 1, wherein said secondary light is light from said first and second light sources which has been reflected from the first and second illumination areas of the sample application area.

4. An analytical system as recited in claim 1, wherein the deviation of the first and second measurement values is determined by said evaluation means based upon a calculation of the difference between the first and second measured values, with said difference being compared to the predetermined threshold value.

5. An analytical system as recited in claim 1, wherein the deviation between the first and second measured values is determined by the evaluation means as a relative deviation, said relative deviation then being compared to the predetermined threshold value.

6. An analytical system as recited in claim 1, further comprising display means connected to said evaluation means, said display means displaying an error message when the deviation between the first and second measured values exceeds the predetermined threshold value, and displaying an analytical result when the deviation between the first and second measured values is smaller than the predetermined threshold value.

7. An analytical system as recited in claim 1, wherein the secondary light detected by the sensor means is diffuse reflected light being diffusely reflected by said first and second illumination areas.

8. An analytical system as recited in claim 1, wherein said first and second illumination areas are separate from each other.

9. An analytical system as recited in claim 1, wherein said first and second illumination areas on said test element include a common part of the sample application area.

10. An analytical system as recited in claim 1, wherein the first and second illumination areas are equal in size.

11. An analytical system as recited in claim 1, wherein the first and second light sources are disposed in a coplanar relationship on a plane which is parallel to a plane of the sample application areas of the test element.

12. An analytical system as recited in claim 1, wherein the first and second light sources have substantially identical spectral intensity distributions and radiation cones.

13. An analytical system as recited in claim 1, wherein a first light path defined between the first light source, the first illumination area, and the sensor means is a mirror image of a second light path between the second light source, the second illumination area, and the sensor means.

14. An analytical system as recited in claim 1, wherein the sample application area comprises a net.

15. An analytical system as recited in claim 14, wherein said net comprises a rectangular mesh.

16. An analytical system as recited in claim 14, wherein a connecting line between a center of the first and second illumination areas of the evaluation zone forms an angle of 45°

with threads of the net.

17. An analytical system as recited in claim 1, wherein said sensor means receives said secondary light from the first and second illumination areas with a same angle of incidence relative to the sample application area, and with a same distance from the first and second illumination areas.

18. An analytical system as recited in claim 1, wherein said first and second light sources and said sensor means are configured to perform quantitative evaluation of the test element.

19. An analytical system as recited in claim 1, comprising two first light sources and two second light sources, thereby forming a first set and a second set of light sources, said first set of light sources having differing spectral intensity distributions from said second set of light sources.

20. An analytical system as recited in claim 1, further comprising storage means connected to said evaluation means, said storage means for storing calibration factors therein, wherein said evaluation means converts the first output signal into the first measured value utilizing the calibration factors stored in the storage means.

21. An analytical system for evaluation of test elements, said analytical system determining consistent application of a sufficient amount of sample liquid, said system comprising:

a light source for illuminating an illumination area of a sample application area of the test element;

a first sensor means for detecting secondary light along a first light path after light from said light source impinges upon the illumination area, said first sensor means generating a first output signal proportional to an intensity of the secondary light along a first light path;

a second sensor means for detecting secondary light along a second light path after light from said light source impinges upon the illumination area, said second sensor means generating a second output signal proportional to an intensity of the secondary light along a second light path;

evaluation means coupled to said first and second sensor means for converting said first output signal to a first measured value and for converting said second output signal to a second measured value, said evaluation means comparing the first and second measured values to determine a deviation therebetween.

22. An analytical system as recited in claim 21, wherein said secondary light detected by said first and second sensor means is light which has been transmitted through said illumination area of said sample application area.

23. An analytical system as recited in claim 21, wherein said secondary light detected by said first and second sensor means is light which is reflected by said illumination area of said sample application area.

24. A method of determining consistent application of a sufficient amount of sample liquid on a test element, said method comprising the steps of:

applying a sample liquid to a sample application area of the test element;

irradiating light from a first light source onto a first illumination area of the sample application area;

detecting secondary light after light from the light source impinges upon the first illumination, thereby generating a first output signal;

irradiating a second illumination area of the sample application area with light from a second light source, said second illumination area being a different area from said first illumination area;

detecting secondary light from said second light source after the light from the light source impinges upon the illumination area, thereby generating a second output signal;

converting said first and second output signals into first and second measured values; and

comparing the first and second measured values to determine a deviation between the measured values.

25. A method as recited in claim 24, wherein said detection steps are performed with a same sensor means.

26. A method as recited in claim 24, wherein said first light source and said second light source are sequentially activated.

27. A method as recited in claim 24, wherein, prior to said step of applying the sample liquid to the sample application area, a series of exposure, detection, conversion and comparison steps are performed to generate factors for converting the first and second output signals.

28. A method as recited in claim 24, wherein, prior to the step of applying a sample liquid to the sample application area, a series of exposure and detection steps are performed on a homogeneous surface thereby generating calibration output signals, and wherein a quotient from the calibration output signals is calculated and used for the conversion of the first and second output signals into the first and second measured values.

29. A method as recited in claim 24, wherein a time between the exposure of the first illumination area and the exposure of the second illumination area is less than 0.5 seconds.