Test strip qualification system

• US 20040096980A1
• Filed: 11/12/2003
• Published: 05/20/2004
• Est. Priority Date: 03/14/2002
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Patel, Harshad
• Granted Patent: US 6,835,570 B2
• Time in Patent Office: Days
• US Class Current: 436/169
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors
• CPC Class Codes: Y10T 436/10 Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

In connection with a fluidic medical diagnostic device that permits measurement of the coagulation time of blood, software, methods and associated devices for quality control are disclosed. The fluidic device preferably comprises a test strip with one end having a sample port for introducing a sample and a bladder at the other end for drawing the sample to a measurement area. A channel carries sample from the sample port to an assay measurement area and first and second control measurement areas. Preferably a stop junction, between the measurement areas and bladder, halts the sample flow for measurement. If results from measurements taken for each control fall within a predetermined zone or defined limits, the assay measurement is qualified. If not, an error is registered and the test strip is counted as unfit.

Claims

1. A method of test strip qualification, said method comprising:

providing a test strip comprising an assay reaction area, a first control reaction area and a second control reaction area;

obtaining PT results for each reaction area;

comparing results from said first control area to first control qualification criteria and results from second control area to second control qualification criteria, wherein said first control qualification criteria comprise an upper limit and a lower limit, said upper limit being at least partially dependent upon assay reaction area PT results; and

outputting a message to a user indicating test strip reliability.

2. The method of claim 1, wherein said upper limit is dependent upon assay reaction area PT results at or below about 2.0 INR.

3. The method of claim 2, wherein said upper limit comprises a linear function dependent upon assay reaction area PT results.

4. The method of claim 3, wherein said upper limit further comprises a value independent of assay reaction area PT result for reaction area PT results at or above about 2.0 INR.

5. The method of claim 3, wherein said lower limit comprises a value independent of assay reaction PT result.

6. The method of claim 1, wherein PT results obtained for each reaction area are INR values.

7. The method of claim 1, wherein said second control qualification criteria comprises an upper limit and a lower limit, said upper limit being dependent upon assay reaction area PT results, said lower limit having first and second sections dependent upon assay reaction area PT results, wherein said second section drops-off from said first section.

17. A system programmed to operate according to a method selected from a group of methods consisting of the test strip qualification methods of claims 1-16.

18. The system of claim 17, further comprising a test strip comprising an assay reaction area, a first control reaction area and a second control reaction area.

19. A computer-readable medium embodying a program to direct a system to perform a method selected from a group of methods consisting of the test strip qualification methods of claims 1-16.

20. A computer-readable medium containing data representing sample results, wherein said data is made by a method selected from a group of methods consisting of the test strip qualification methods of claims 1-16.

8. A method of test strip qualification, said method comprising:

providing a test strip comprising an assay reaction area, a first control reaction area and a second control reaction area;

obtaining PT results for each reaction area;

comparing results from said first control area to first control qualification criteria and results from second control area to second control qualification criteria, wherein said second control qualification criteria comprise an upper limit and a lower limit, said upper limit being dependent upon assay reaction area PT results, said lower limit having first and second sections dependent upon assay reaction area PT results, wherein said second section drops-off from said first section; and

outputting a message to a user indicating test strip reliability.

9. The method of claim 8, wherein said lower limit first and second sections comprise linear functions.

10. The method of claim 8, wherein said first section and said second section coincide at an assay reaction area PT result of about 4.0 INR.

11. The method of claim 8, wherein said upper limit comprises a linear function.

12. The method of claim 8, wherein PT results obtained for each reaction area are INR values.

13. The method of claim 8, wherein said first control qualification criteria comprises an upper limit and a lower limit, said upper limit being at least partially dependent upon assay reaction area PT results.

14. A method of test strip qualification comprising:

providing a test strip comprising an assay reaction area, a first control reaction area and a second control reaction area;

obtaining PT results for each reaction area; and

comparing test strip results from said first control reaction area to a first set of criteria substantially as represented in FIG. 4 and comparing results from said second control reaction area to a second set of criteria.

15. The method of claim 14, wherein said second set of criteria are substantially as represented in FIG. 5.

16. A method of test strip qualification comprising:

providing a test strip comprising an assay reaction area, a first control reaction area and a second control reaction area;

obtaining PT results for each reaction area; and

comparing test strip results from said first control reaction area to a first set of criteria and comparing results from said second control reaction area to a second set of criteria substantially as represented in FIG. 5.