Test system

• US 7,818,132 B2
• Filed: 06/01/2006
• Issued: 10/19/2010
• Est. Priority Date: 06/10/2005
• Status: Active Grant

• Current Assignee: ARKRAY, Inc
• Original Assignee: Arkray Factory Ltd. (ARKRAY, Inc)
• Inventors: Kent, Nicholas Young, Pritchard, G. John, Rippeth, John J.
• Primary Examiner(s): Tsai; Carol S
• Application Number:
  US11/921,882
• Publication Number:
  US 20090119024A1
• Time in Patent Office: 1,601 Days
• Field of Search: 702/23, 600/365, 600/309, 340/572.1, 422/68.1, 738/649.1, 73/614.8, 73/617.1, 73/645.6, 235/472.01
• US Class Current: 702/23
• CPC Class Codes: A61B 2560/0456 Apparatus provided with a docking unit
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 33/48792 Data management, e.g. communication with processing unit for in vivo diagnostics A61B5/0002; transmission systems for measured values G08C

Abstract

A test system for measuring the concentration of an analyte in a biological fluid sample comprises: a plurality of test members (16) in a container (10), each test member (16) including reagent means for indicating the catalytic activity of an enzyme when in the presence of a biological fluid containing an analyte acted upon by the enzyme; 0 a test meter (2) for receiving a test member (16), the meter (2) having circuitry for performing a measurement on a test member received therein to produce a measured physical value, means for determining an analyte concentration value for a specified biological fluid from said measured physical value, and means (4) for indicating a determined analyte concentration value; a Container RFID tag (14) associated with the container (10) which includes data specific to said plurality of test members (16); and a Patient RFID tag (28) which includes data specific to a patient; and wherein said test meter (2) includes means for reading and storing data from said Container RFID tag (14) and from said Patient RFID tag (28).

Claims

1. A test system for measuring the concentration of an analyte in a biological fluid sample, the system comprising:

a plurality of test members in a container, each test member including reagent means for indicating the catalytic activity of an enzyme when in the presence of a biological fluid containing an analyte acted upon by the enzyme;

a test meter for receiving a test member, the meter having circuitry for performing a measurement on a test member received therein to produce a measured physical value, means for determining an analyte concentration value for a specified biological fluid from said measured physical value, and means for indicating a determined analyte concentration value;

a Container RFID tag associated with the container which includes data specific to said plurality of test members; and

a Patient RFID tag which includes data specific to a patient;

and wherein said test meter includes means for reading and storing data from said Container RFID tag and from said Patient RFID tag;

wherein the test meter is programmed to require input from each of said RFID tags before an analyte concentration measurement can be taken; and

wherein the test meter is programmed to signal an error condition if an analyte concentration measurement has not been made within a pre-set time from reading data from one of the Container RFID tag and the Patient RFID tag.

2. A test system according to claim 1, further comprising an Operator RFID tag to be associated with an operator and which includes operator-specific data;

and wherein the test meter includes means for reading and storing data from the Operator RFID tag.

3. A test system according to claim 1, wherein the data readable from the Container RFID tag include calibration data relating to a batch of test members in the container.

4. A test system according to claim 3, wherein the data readable from the Container RFID tag further include data relating to the test members in the container and selected from:

the lot number, the date of manufacture of the test members, the shelf life of the test members, and open-date or expiry-date deadlines.

5. A test system according to claim 1, further comprising a reader for receiving analyte concentration value data and associated data from the meter and for transferring said data to a computer database.

6. A test system according to claim 1, wherein the or each RFID tag is passive.

7. A test system according to claim 1, wherein the or each RFID tag must be positioned less than 10 cm from the test meter for the meter to read data therefrom.

8. A test system according to claim 1, wherein the or each RFID tag must be positioned less than 5 cm from the test meter for the meter to read data therefrom.

9. A test system for measuring the concentration of an analyte in a biological fluid sample, the system comprising:

a plurality of test members in a container, each test member including reagent means for indicating the catalytic activity of an enzyme when in the presence of a biological fluid containing an analyte acted upon by the enzyme;

a test meter for receiving a test member, the meter having circuitry for performing a measurement on a test member received therein to produce a measured physical value, means for determining an analyte concentration value for a specified biological fluid from said measured physical value, and means for indicating a determined analyte concentration value;

a Container RFID tag associated with the container which includes data specific to said plurality of test members; and

a Patient RFID tag to be associated with a patient and which includes data specific to a patient;

an Operator RFID tag to be associated with an operator and which includes operator-specific data;

wherein said test meter includes means for reading and storing data from the Container RFID tag, from the Patient RFID tag, and from the Operator RFID tag; and

wherein the test meter is programmed to require input from each of said RFID tags before an analyte concentration measurement can be taken; and

wherein the test meter is programmed to signal an error condition if an analyte concentration measurement has not been made within a pre-set time from reading data from one of the Container RFID tag, the Patient RFID tag and the Operator RFID tag.

10. A test system according to claim 9, further comprising a reader for receiving analyte concentration value data and associated data from the meter and for transferring said data to a computer database.

11. A test system according to claim 9, wherein the or each RFID tag is passive.

12. A test system according to claim 9, wherein the or each RFID tag must be positioned less than 10 cm from the test meter for the meter to read data therefrom.

13. A test system according to claim 9, wherein the or each RFID tag must be positioned less than 5 cm from the test meter for the meter to read data therefrom.