System for analyzing sample liquids containing a position control unit

• US 6,906,802 B2
• Filed: 12/04/2001
• Issued: 06/14/2005
• Est. Priority Date: 12/08/2000
• Status: Expired due to Term

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Voelkel, Dirk
• Primary Examiner(s): Rosenberger, Richard A.
• Application Number:
  US10/008,600
• Publication Number:
  US 20020167668A1
• Time in Patent Office: 1,288 Days
• Field of Search: 356/39, 356/446, 422/82.05
• US Class Current: 356/446
• 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 21/8483 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

System for analyzing sample liquids by evaluating test elements with an analytical unit (20) in which a test element (10) to be analyzed is positioned by a holder (21, 22, 120, 140) in an analytical position relative to the analytical unit and the system additionally comprises a position control unit to check whether an analytical area of the test element is correctly positioned relative to the analytical unit wherein the position control unit comprises a light source (30, 2) to irradiate an area of the test element and preferably the analytical area (11), a detector (31, 131) to detect light reflected from the area and an evaluation unit, and the light source and detector are positioned relative to one another in such a manner that the light intensity of specularly reflected radiation at the detector when the test element is correctly positioned is different from a light intensity when it is incorrectly positioned and the evaluation unit recognizes any faulty positioning on the basis of the light intensity at the detector.

In addition the invention concerns a method for sample analysis using a position control unit to check whether a test element is correctly positioned relative to an evaluation optics.

Claims

1. A system for analyzing sample liquids by evaluating test elements with an analytical unit in which a test element to be analyzed is positioned by a holder in an analytical position relative to the analytical unit, the system comprising, a position control unit to check whether an analytical area of the test element is correctly positioned relative to the analytical unit wherein the position control unit comprises:

(a) a light source to irradiate an area of the test element,

(b) a detector to detect light reflected from the area, and

(c) an evaluation unit, wherein the light source and detector are positioned relative to one another in such a manner that the light intensity of specularly reflected radiation from the test strip at the detector when the test element is correctly positioned is different from the light intensity of reflected radiation from the test element at the detector when it is incorrectly positioned, and the evaluation unit is adapted to recognize any faulty positioning on the basis of the light intensity at the detector.

2. The system of claim 1, in which the light source and detector are arranged relative to one another in such a manner than when the test element is correctly positioned, specularly reflected radiation falls on the detector and the proportion of specularly reflected radiation decreases when a faulty positioning occurs.

3. The system of claim 2, in which the proportion of specularly reflected radiation of the light source for position control decreases at the detector when a faulty positioning occurs.

4. The system of claim 1, in which the light source and detector are arranged relative to one another in such a manner that when the test element is correctly positioned, the proportion of radiation specularly reflected from the test element is small or zero and is larger when the test element is incorrectly positioned.

5. The system of claim 1, in which the analytical unit is used to irradiate the analytical area and the concentration of an analyte is determined on the basis of the radiation reflected from the analytical area or transmitted through the analytical area.

6. The system of claim 5, in which the analytical unit uses the detector of the position control unit to detect radiation.

7. The system of claim 5, in which the analytical unit uses the light source of the position control unit to irradiate the analytical area.

8. The system of claim 1, in which the test element is deformable along its longitudinal axis, is held in an area at one end of the axis by a holder and the analytical area is at a distance from said one end of the axis such that a faulty positioning of the analytical area relative to the analytical unit occurs when the test element is bent along its longitudinal axis.

9. The system of claim 1, in which the analytical unit has a measuring light source and a control unit sequentially actuates the measuring light source and the light source of the position control unit.

10. The system of claim 9, in which the measuring light source irradiates the analytical area below an angle of a and the light source of the position control unit irradiates the analytical area below an angle of β

relative to the normal plane whereby α

<

β

.

11. The system of claim 1, in which the position control unit comprises a second light source which is positioned relative to the detector in such a manner that at the detector the light intensity of this radiation reflected from the test element changes inversely to the light intensity of the light source for position control when the test element is moved away form its correct position.

12. A method for analyzing sample liquids comprising evaluating test elements using an analytical unit in which a position control unit is used to check whether an analytical area of the test element is positioned correctly relative to the analytical unit, irradiating an area of the test element by a light source, detecting radiation reflected from the area, recording a signal generated by the detecting step to check the position of the analytical area wherein the light source and detector are positioned relative to one another in such a manner that the intensity of radiation reflected from the test element and detected is different when the analytical area is correctly positioned than the intensity when it is incorrectly positioned, and indicating to a user whether the analytical area is positioned correctly relative to the analytical unit.

13. The method of claim 12, in which the analytical unit has a separate light source and a detector is used for the detecting step and the light source of the position control unit is actuated at a time point T_K and the light source of the analytical element is actuated at a time point T_A and the position of the analytical area is checked on the basis of the signal generated by the detector at time point T_K and an evaluation to determine the concentration of an analyte is carried out based on the signal generated at time point T_A.

14. The method of claim 13, in which the time points T_K and T_A are les than one second apart.