Sample detection to initiate timing of an electrochemical assay

• US 6,193,873 B1
• Filed: 06/15/1999
• Issued: 02/27/2001
• Est. Priority Date: 06/15/1999
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Kermani, Mahyar Z., Teodorczyk, Maria, Ohara, Timothy J.
• Primary Examiner(s): Tung, T.
• Assistant Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US09/333,793
• Time in Patent Office: 623 Days
• Field of Search: 205/775, 205/777.5, 205/792, 204/400, 204/406, 204/403
• US Class Current: 205/792
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

Abstract

An electrochemical assay includes a method for determining with great accuracy the time at which an applied sample bridges a gap between the electrodes of an electrochemical cell. The method involves applying a constant small current across the gap, while monitoring the potential difference between the electrodes. The time at which the sample bridges the gap is marked by a sharp drop in the potential. A constant voltage is applied after the sample is detected, and the current and/or charge through the sample is monitored over a period of time. From the measured current or charge, the analyte concentration of interest can be calculated.

Claims

1. A method for measuring an analyte concentration in a sample of a biological fluid that is applied to an electrochemical diagnostic strip of the type that includes juxtaposed working and reference electrodes comprising

(a) applying a predetermined, constant current source between the working and reference electrodes,

(b) monitoring a potential difference across the electrodes,

(c) applying the sample to the strip,

(d) determining a sample detection time by noting when the potential difference falls below a predetermined threshold voltage,

(e) applying a predetermined constant voltage to the sample,

(f) measuring an electrical response at a predetermined time after applying the constant voltage, and

(g) calculating the analyte concentration using the measured electrical response.

2. The method of claim 1 in which the electrical response measured is current through the sample at the predetermined time.

3. The method of claim 1 in which the electrical response measured is charge passing through the sample from the sample detection time to the predetermined time.

4. The method of claim 1, further comprising applying a second predetermined voltage after the predetermined time and measuring a second electrical response after applying the second predetermined voltage.

5. The method of claim 4 in which the second electrical response is a rate of decay of current through the sample.

6. The method of claim 4 in which the second electrical response is charge passing through the sample during a predetermined time interval after the second voltage is applied.

7. A meter for measuring an analyte concentration in a sample of a biological fluid that has been applied between a working and reference electrode of a diagnostic strip comprising, in electrical communication,

(a) means for applying a predetermined current between the working and reference electrodes,

(b) means for monitoring a potential difference across the electrodes,

(c) means for determining when the potential difference falls below a predetermined threshold voltage to indicate sample detection,

(d) means responsive to sample detection for applying a predetermined constant voltage to the sample,

(e) means for measuring a resulting electrical response, and

(f) means for calculating the analyte concentration by using the measured electrical response.

8. The meter of claim 7 in which the means for measuring a resulting electrical response is an ammeter.

9. The meter of claim 7 in which the means for measuring a resulting electrical response is a coulometer.

10. The meter of claim 7 further comprising means for applying a second predetermined voltage to the sample and means for measuring a second resulting electrical response.

11. The meter of claim 10 in which the means for measuring a second resulting electrical response is an ammeter.

12. The meter of claim 10 in which the means for measuring a second resulting electrical response is a coulometer.

13. A method for measuring an analyte concentration in a sample of a biological fluid that is applied to an electrochemical diagnostic strip of the type that includes juxtaposed working and reference electrodes comprising

(a) applying a predetermined, constant current source between the working and reference electrodes,

(b) monitoring a potential difference across the electrodes,

(c) applying the sample to the strip,

(d) determining a sample detection time by noting when the potential difference falls below a predetermined threshold voltage,

(e) applying a predetermined constant voltage to the sample,

(f) applying a second predetermined voltage to the sample after a first predetermined time,

(g) measuring an electrical response at a predetermined time after the first predetermined time, and

(h) calculating the analyte concentration using the measured electrical response.

14. The method of claim 13 in which the electrical response measured is a rate of decay of current through the sample.

15. The method of claim 13 in which the electrical response measured is the charge passing through the sample during a predetermined time interval after the second predetermined voltage is applied.