Test cell for use with medical diagnostic instrument

• US 20060108218A1
• Filed: 01/05/2006
• Published: 05/25/2006
• Est. Priority Date: 03/05/2001
• Status: Abandoned Application

• Current Assignee: Clinical Analysis Corporation
• Original Assignee: Clinical Analysis Corporation
• Inventors: Rello, Michael J., Gephart, Chad Stephen, Shive, Donald Wayne, McBrairty, Edward James, Loesch, H. William, McBrairty, Charles Francis, Sharpless, Thomas Kite
• Application Number:
  US11/325,839
• Publication Number:
  US 20060108218A1
• Time in Patent Office: Days
• US Class Current: 204/400
• CPC Class Codes: A61B 2560/0223 of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14535 for measuring haematocrit
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: G01N 33/48771 Coding of information, e.g. calibration data, lot number

Abstract

A disposable, single use test cell is provided for receiving fluid to be diagnostically tested by an instrument. The test cell includes a housing sized and shaped for engagement by the instrument when a diagnostic test is to be performed, the housing including at least one chamber, at least one pair of electrodes within the chamber and in electrical contact with circuitry within the instrument when the housing is engaged by the instrument and a specimen capsule containing the fluid to be tested.

Claims

1. A disposable, single use test cell for receiving a fluid to be diagnostically tested by an instrument, the test cell comprising:

a housing sized and shaped for engagement by the instrument when a diagnostic test is to be performed, the housing including a least one chamber, a first bore in fluid communication with the at least one chamber and a second bore in fluid communication with the at least one chamber;

a pair of electrodes within the at least one chamber for performing ion selective analysis, the electrodes being in electrical contact with circuitry within the instrument when the housing is engaged by the instrument;

a calibration capsule within the first bore, the calibration capsule containing calibration fluid for calibrating the electrodes; and

a specimen capsule within the second bore, the specimen capsule containing the fluid to be tested whereby calibration fluid from the calibration capsule flows from the first bore to the at least one chamber for calibration of the electrodes and the fluid to be tested flows from the specimen capsule through the second bore to the at least one chamber for analysis by the electrodes.

2. The test cell as recited in claim 1 wherein the type of calibration fluid within the calibration capsule is determined by the particular diagnostic test to be performed on the fluid within the specimen capsule.

3. The test cell as recited in claim 1 wherein the calibration fluid flows into the at least one chamber first and is removed from the at least one chamber prior to the fluid from the specimen capsule flowing into the chamber.

4. The test cell as recited in claim 1 wherein at least one of the electrodes is covered by an electrolyte which is determined by the diagnostic test to be performed using the test cell.

5. The test cell as recited in claim 4 wherein the electrolyte is covered by an ion selective membrane so that the calibration fluid and the fluid to be tested contacts the ion selective membrane.

6. The test cell as recited in claim 1 wherein the calibration fluid is caused to flow into the chamber by pushing the calibration capsule into the first bore.

7. The test cell as recited in claim 1 wherein the housing further includes an overflow chamber for receiving fluid to be tested or calibration fluid which overflows the at least one chamber.

8. The test cell as recited in claim 1 wherein the housing further includes identification information which uniquely identifies the test cell.

9. The test cell as recited in claim 8 wherein the identification information also identifies a particular diagnostic test to be performed on the fluid within the test cell.

10. The test cell as recited in claim 9 wherein the identification information comprises indicia on the test cell housing.

11. The test cell as recited in claim 10 wherein the indicia comprises a barcode which uniquely identifies the test cell.

12. The test cell as recited in claim 1 wherein the size and shape of the housing permits engagement by the instrument with the housing having only a single, predetermined orientation and precludes engagement by the instrument with the test cell in any other orientation.

13. The test cell as recited in claim 1 wherein the housing includes two chambers, the first and second bores being in fluid communication with both of the chambers, one of the electrodes of the electrode pair being located within one of the chambers and the other electrode of the electrode pair being located within the other chamber.

14. The test cell as recited in claim 13 wherein a diagnostic test is performed by inserting calibration fluid into both chambers and measuring the voltage potential between the electrodes, inserting the fluid to be tested into one of the chambers and measuring the voltage potential between the electrodes and comparing the measured voltage potentials.

15. The test cell as recited in claim 1 wherein the housing includes a single chamber with the electrodes being positioned at spaced locations within the single chamber.

16. The test cell as recited in claim 15 wherein a diagnostic test is performed by inserting calibration fluid into the test cell and measuring current flow between the electrodes, inserting a fluid to be tested into the test cell and measuring current flow between the electrodes and comparing the result of the two current measurements.

17. A disposable, single use test cell for receiving a fluid to be diagnostically tested by an instrument, the test cell comprising:

a housing sized and shaped for engagement by the instrument when a diagnostic test is to be performed, the housing including two elongated chambers of substantially the same dimensions and length and a bore in fluid communication with both chambers;

a first pair of electrodes with each electrode of the first pair being located at an end of one of the chambers, the electrodes of the first pair being in electrical contact with circuitry within the instrument when the housing is engaged by the instrument;

a second pair of electrodes with each of the electrodes of the second pair being located at an end of the other chamber, the electrodes of the second pair being in electrical contact with circuitry within the instrument when the housing is engaged by the instrument; and

a specimen capsule within the bore, the specimen capsule containing the fluid to be tested whereby the fluid to be tested flows from the specimen capsule and into the two chambers, the fluid flowing into one of the chambers being subjected to a lysing agent prior to flowing into the one chamber.

18. The test cell as recited in claim 17 wherein the housing further includes identification information which uniquely identifies the test cell.

19. The test cell as recited in claim 18 wherein the identification information comprises indicia on the test cell housing.

20. The test cell as recited in claim 19 wherein the indicia comprises a barcode which uniquely identified the test cell.

21. The test cell as recited in claim 17 wherein the diagnostic test is performed by measuring the conductivity of the fluid within the one chamber utilizing the first pair of electrodes, measuring the conductivity of the fluid within the other chamber utilizing the second pair of electrodes and comparing the conductivity measurements.