Test strip qualification system

• US 6,682,933 B2
• Filed: 03/14/2002
• Issued: 01/27/2004
• Est. Priority Date: 03/14/2002
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Patel, Harshad, Witt, James
• Primary Examiner(s): WALLENHORST, MAUREEN
• Application Number:
  US10/100,254
• Publication Number:
  US 20030175158A1
• Time in Patent Office: 684 Days
• Field of Search: 436/8, 436/63, 436/69, 436/180, 422/73, 422/100, 435/13, 600/368, 600/369, 73/644.1, 702/19, 702/31, 702/32
• US Class Current: 436/8
• CPC Class Codes: G01N 33/4905 Determining clotting time of blood by chemical methods G01N33/86, C12Q1/56
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• 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 includes 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 prothrombin results for each reaction area;

comparing results from said first control area to a first control qualification criteria and results from said second control area to a second control qualification criteria, wherein said first control qualification criteria comprises an upper limit and a lower limit, said first control upper limit being about a 1.9 International Normalized Ratio and said first control lower limit being about a 0.60 International Normalized Ratio; and

outputting a message to a user indicating test strip reliability.

2. 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 prothrombin results, said lower limit having first and second sections dependent upon assay reaction area prothrombin results.

3. The method of claim 2, wherein said second control criteria upper limit comprises a line function and said second control criteria lower limit comprises a line function.

4. The method of claim 3, wherein said line functions are expressed as:

9. A system programmed to operate according to a method selected from a group of methods consisting of the test strip qualification methods of claims 1-8.

10. The system of claim 9, further comprising a test strip comprising an assay reaction area, a first control reaction area and a second control reaction area.

11. 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 1-8.

12. 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 1-8.

5. 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 prothrombin results for each reaction area;

comparing results from the first control area to first control qualification criteria and comparing results from said second control area to second control qualification criteria, wherein said second control qualification criteria comprises an upper limit and a lower limit, each being dependent on assay reaction area prothrombin results; and

outputting a message to a user indicating test strip reliability.

6. The method of claim 5, wherein said second control criteria upper and lower limits comprise line functions.

7. The method of claim 6, wherein said line functions are expressed as:

8. The method of claim 5, wherein said first control qualification criteria comprises an upper limit and a lower limit, said first control upper limit being about a 1.9 International Normalized Ratio and said first control lower limit being about a 0.60 International Normalized Ratio.