Quantitative analysis method and its system using a disposable sensor

• US 5,266,179 A
• Filed: 07/19/1991
• Issued: 11/30/1993
• Est. Priority Date: 07/20/1990
• Status: Expired due to Term

• Current Assignee: Kyoto Daiichi Kagaku Company Limited, Matsushita Electric Industrial Company Limited (Panasonic Holdings Corporation)
• Original Assignee: Kyoto Daiichi Kagaku Company Limited, Matsushita Electric Industrial Company Limited (Panasonic Holdings Corporation)
• Inventors: Yoshioka, Masahiro, Hyodo, Hiroshi, Terao, Kyozo, Tanimoto, Naoki, Uchigaki, Takatoshi, Yoshioka, Toshihiko, Nankai, Shiro, Kawaguri, Mariko, Tsutsumi, Haruhiro
• Primary Examiner(s): Niebling, John
• Assistant Examiner(s): Bell, Bruce F.
• Application Number:
  US07/733,130
• Time in Patent Office: 865 Days
• Field of Search: 204/401, 204/400, 204/403, 204/416, 204/418, 204/419
• US Class Current: 204/401
• CPC Class Codes: G01N 2035/009 alarms, e.g. audible
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A sensor 13 is inserted into a connector 14. A constant voltage required to obtain a response current is applied across the connector 14 by a voltage applying source 15 at timings required. A response current of the sensor 13 inserted into the connector 14 is converted into a voltage by a current-to-voltage converter 16, and the amount thereof is determined by a microcomputer, the analysis results being displayed onto a display unit.

Claims

1. A quantitative analysis system for measuring a specific component in biological body fluid by an amperometric method, comprising:

a disposable sensor mounting portion, including a disposable sensor for receiving a sample of the biological body fluid for analysis; and

means for automatically determining whether a chip mounted on said disposable sensor mounting portion is a sensor for measuring the sample, or an adjustment chip, depending on a measured current value flowing through said system when said chip is mounted on said disposable sensor mounting portion.

2. A quantitative analysis system for measuring a specific component in biological body fluid by an amperometric method, comprising:

a disposable sensor for receiving a sample of the biological body fluid for analysis; and

means for automatically distinguishing whether the disposable sensor is used depending on a stability of a measured current value of said disposable sensor.

3. The quantitative analysis system of claim 2, wherein said disposable sensor including an electrode for detecting a liquid junction.

4. A quantitative analysis system comprising:

means for applying a reaction voltage to a sensor;

means for detecting that a sample liquid is supplied to said sensor;

means for interrupting the reaction voltage based on said detection;

means for reapplying said reaction voltage to said sensor after a specified time period;

means for detecting a reaction state of said sensor due to reapplication of said reaction voltage; and

means for displaying the reaction state.

5. The quantitative analysis system of claim 4, said system further comprising means for detecting that said sensor has been mounted on the system, wherein said reaction voltage application means is initiated by said detection.

6. The quantitative analysis system of claim 4 or 5, wherein said reaction voltage application means includes a current-to-voltage converter, for generating a voltage depending on a current generated in said sensor as a result of the application voltage and said reaction state detection means includes a CPU and detects said reaction state based on an output of said current-to-voltage converter and converts said reaction state to a digital value.

7. A quantitative analysis system comprising:

disposable sensor means, including a capillary shaped portion and an enzyme portion, for receiving a sample liquid for analysis;

control means, including a connector for said disposable sensor means, for allowing enzymes in said enzyme portion and the sample liquid to react in an absence of a reaction voltage, for automatically applying the reaction voltage to the reaction after a specified time period, and for measuring an oxidation current indicative of a concentration of a constituent part of the sample liquid; and

calibrating and testing means for calibrating and testing said system without key operation.

8. The quantitative analysis system of claim 7, wherein said system is portable.

9. The quantitative analysis system of claim 7, said calibrating and testing means including,

means for automatically distinguishing whether said disposable sensor means has been placed in said connector with the sample liquid or without the sample liquid and for distinguishing whether an adjustment chip has been placed in said connector, depending on the measured current.

10. The quantitative analysis system of claim 9, wherein the adjustment chip is an adjustment mode switching chip, an instrumental error compensating chip, a calibration chip, a test chip, or a unit switching chip.

11. The quantitative analysis system of claim 10, wherein when the adjustment chip is the adjustment mode switching chip, which has a constant low resistance with a range assigned to the adjustment mode switching chip in order to adjust the reaction voltage.

12. The quantitative analysis system of claim 11, wherein two instrumental error compensating chips are sequentially inserted in said connector after the adjustment mode switching chip in order to compensate a resistance of said system.

13. The quantitative analysis system of claim 9, wherein the adjustment chip is the calibration chip and said system generates a constant resistance with a range assigned to the calibration chip in order to select an appropriate calibration curve.

14. The quantitative analysis system of claim 9, wherein the adjustment chip is the test chip and said system generates a constant resistance with a range assigned to the test chip in order to identify and abnormalities in said system.

15. The quantitative analysis system of claim 9, wherein the adjustment chip is the unit switching chip and said system generates a constant resistance with a range assigned to the unit switching chip in order to set a unit corresponding to the measured current.

16. The quantitative analysis system of claim 7, said disposable sensing means including a liquid junction detection electrode, said control means monitoring said liquid detection electrode in order to determine whether a liquid junction exists.

17. The quantitative analysis system of claim 10, said disposable sensing means including a mediator, and said mediator contacts blood glucose in the presence of glucose oxidase to produce potassium ferrocyanide, and after the predetermined time, the reaction voltage is applied to said disposable sensing means to produce the oxidation current which is proportional to the potassium ferrocyanide level and representative of the blood glucose level.

18. The quantitative analysis system of claim 10, wherein said enzyme portion acts as a resistor, said control means including,

means for determining whether said disposable sensing means or said adjustment chip has been inserted in said connector,

voltage means for applying the reaction voltage across said connector, and

correcting means for converting the oxidation current into a voltage, said voltage represented by:

space="preserve" listing-type="equation">Eo=E+i * Rf=E+(E/Rs) * Rf

where;

Eo=said voltage,

E=the reaction voltage,

Rf=an amplification resistance of said converting means, and

Rs=a resistance value of said enzyme portion.

19. The quantitative analysis system of claim 18, said calibrating and testing means including means for automatically determining the type of adjustment chip according to said voltage.

20. The quantitative analysis system of claim 10, said control means including a second connector for receiving the adjustment chip.

21. The quantitative analysis system of claim 7, said disposable sensing means including,

a substrate, including a counter electrode, a measuring electrode, and at least one lead,

a insulating layer,

a reaction layer, including an enzyme and a mediator which cover said counter electrode and said measuring electrode,

a spacer, with longitudinal groove,

a cover, with an air hole through which the sample liquid is placed on the reaction layer, and

an inverse-inserting preventing protrusion for ensuring said disposable sensing means is correctly oriented in said connector.

22. The quantitative analysis system of claim 7, wherein said control means includes a standby switch for initiating the specified time period.