Fail judging method and analyzer

• US 7,008,525 B2
• Filed: 11/18/2002
• Issued: 03/07/2006
• Est. Priority Date: 11/20/2001
• Status: Expired due to Term

• Current Assignee: ARKRAY, Inc, PHC Corporation (PHC Holdings Corporation)
• Original Assignee: ARKRAY, Inc, Matsushita Electric Industrial Company Limited (Panasonic Holdings Corporation)
• Inventors: Morita, Yoshimitsu, Oura, Yoshimi, Shinno, Teppei
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US10/496,041
• Publication Number:
  US 20050067301A1
• Time in Patent Office: 1,205 Days
• Field of Search: 204/401, 20440301-420, 205/775, 205/777.5, 205/778, 205786-7945, 324/425, 324/435, 324/522, 324/523
• US Class Current: 205/777.5
• CPC Class Codes: G01N 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771

Abstract

An analyzer (A) includes a current measurer (42) for measuring the current flowing between paired electrodes (22a), (22b) when a sample is introduced to the reagent layer (23) of a sensor (2) and voltage is applied across the electrodes, while also including a processor (3) for analyzing the sample based on the current after a predetermined reference time point. The analyzer (A) further includes a fail determiner (44) which monitors the change of the current before and after the reference time point and determines that the sensor (2) is improper when the current change does not correspond to a predetermined current change.

Claims

1. A fail judging method for determining properness or improperness of a sensor used for analysis of a sample, the analysis comprising:

introducing the sample to a reagent layer of the sensor;

applying a voltage to the reagent layer and the sample via a pair of electrodes;

measuring current between the electrodes;

setting a reference time point as a time point when the current reaches a predetermined threshold for detection of the introduction of the sample; and

obtaining an analysis result based on current measured after the reference time point;

wherein the method comprises;

observing change of the current before and after the reference time point; and

determining that the sensor is improper when the change in current before the reference time point or the change in current after the reference time point differs from a predetermined change before the reference time point or a predetermined change after the reference time point, respectively.

2. The fail judging method according to claim 1, wherein the reagent layer causes current flowing between the electrodes to exhibit a monotonous increase in a wider sense for a certain period after the sample is introduced, and

wherein the sensor is determined to be proper when the current changes to exhibit only a monotonous increase in a strict sense with a gradient falling in a predetermined range for a predetermined period after the reference time point, whereas otherwise the sensor is determined to be improper.

3. The fail judging method according to claim 1,

wherein the sensor is determined to be a used one when the current changes from an increase to a decrease during a predetermined period around the reference time point and exhibits a peak value larger than a predetermined value.

4. The fail judging method according to claim 1, wherein the sensor is determined to have been exposed over a certain period when the current changes from an increase to a decrease during a predetermined period around the reference time point and exhibits a peak value no larger than a predetermined value.

5. The fail judging method according to claim 1, wherein life of the sensor is determined to have expired when the sensor is determined to be improper and the current does not change from an increase to a decrease during a predetermined period around the reference time point.

6. An analyzer comprising:

a sensor mount portion for mounting a sensor which includes a reagent layer to which a sample is introduced and a pair of electrodes for applying voltage to the reagent layer;

a current measurer for measuring current between the electrodes when voltage is applied across the electrodes; and

a processor adapted for analyzing the sample based on current after a reference time point which is preset for a time point when the current measured by the current measurer reaches a predetermined threshold for detection of the introduction of the sample;

wherein the analyzer comprises a fail determiner adapted for monitoring change of the current before and after the reference time point and for determining that the sensor is improper when the change in current before the reference time point or the change in current after the reference time point differs from a predetermined change before the reference time point or a predetermined change after the reference time point, respectively.

7. The analyzer according to claim 6, wherein the reagent layer causes current flowing between the electrodes to exhibit a monotonous increase in a wider sense for a certain period after the sample is introduced, and

wherein the fail determiner determines that the sensor is proper when the current changes to exhibit only a monotonous increase in a strict sense with a gradient in a predetermined range for a predetermined period after the reference time point, whereas otherwise the determiner determines that the sensor is improper.

8. The analyzer according to claim 6, further comprising a notifier for providing a notice when the fail determiner determines that the sensor is improper.