Method and system for determining the acceptability of signal data collected from a prothrombin time test strip

• US 7,010,432 B2
• Filed: 08/30/2002
• Issued: 03/07/2006
• Est. Priority Date: 08/30/2002
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Kermani, Mahyar Z.
• Primary Examiner(s): Brusca, John S.
• Application Number:
  US10/231,929
• Publication Number:
  US 20040043440A1
• Time in Patent Office: 1,285 Days
• Field of Search: 702/19, 435/4
• US Class Current: 702/19
• CPC Class Codes: G01N 33/523 the element being adapted for a specific analyte
• CPC Class Codes: G01N 33/86 involving blood coagulating time or factors, or their receptors

Abstract

A method for determining the acceptability of signal data collected from a prothrombin time (PT) test strip includes collecting PT signal data from an assay area and control areas of the PT test strip. Relationships between PT signal data collected from the assay area and PT signal data collected from each of the control areas (e.g., a ratio of post-peak pseudo-slopes) are then ascertained. A determination is subsequently made, based on the relationships, as to whether the PT signal data collected from the assay area is acceptable or not for use in calculating a PT and/or an International Normalization Ratio (INR). This determination can include, for example, comparing the relationships to at least one predetermined threshold limit. A prothrombin time (PT) monitoring system includes a PT test strip and a device. The PT test strip includes an assay area and a control area. The device (e.g., a portable handheld meter) includes an optical measurement means (e.g., an LED/photo-detector pair) for measuring an optical property (e.g., absorption) of the assay area and control areas, an analog-to-digital converter module, a microprocessor module and a memory module. The optical measurement means, analog-to-digital converter module, microprocessor module and memory module are adapted to (i) collect PT signal data from the assay area and control areas; (ii) ascertain at least one relationship between PT signal data collected from the assay and control areas and (iii) determine, based on the at least one relationship, whether the PT signal data collected from the assay area is acceptable.

Claims

1. A method for determining the acceptability of signal data collected from a prothrombin time (PT) test strip, the method comprising:

collecting prothrombin time (PT) signal data from an assay area of a PT test strip and PT signal data from at least one control area of the PT test strip;

ascertaining at least one relationship between PT signal data collected from the assay area and PT signal data collected from the at least one control area; and

determining, based on the at least one relationship, whether the PT signal data collected from the assay area is acceptable by comparing the at least one relationship to at least one predetermined threshold limit,

wherein the at least one relationship is selected from the relationship group consisting of a ratio of a post-peak pseudo-slope of PT signal data from the assay area and a post-peak pseudo-slope of PT signal data from at least one control area, a ratio of a peak width of PT signal data from the assay area and peak width of PT signal data from the at least one control area, and a ratio of an area underneath the PT signal data from the assay area and the area underneath the PT signal data from the at least one control area; and

wherein the predetermined threshold limit is based on PT signal data collected from standard reference PT test strips.

2. The method of claim 1, wherein the ascertaining step ascertains the at least one relationship using a technique that includes:

resolving a peak point of the PT signal data collected from the assay area and a peak point of the PT signal data collected from the at least one control area;

selecting a first post-peak window of the PT signal data collected from the assay area and a second post-peak window of the PT signal data collected from the at least one control area;

calculating the post-peak pseudo-slopes for the first and second post-peak window; and

calculating a ratio of the post-peak pseudo-slope of the first window and the post-peak pseudo-slope of the second window, thereby ascertaining the ratio as the at least one relationship.

3. The method of claim 2, wherein the post-peak psdueo-slopes for the first and second post-peak windows are calculated using a least-squares fitted-line technique.

4. The method of claim 2, wherein the selecting step selects the first and second post-peak windows using predetermined fixed window widths and predetermined fixed window start indices.

5. The method of claim 1, wherein the determining step includes normalizing the relationship and comparing the normalized relationship to a predetermined threshold limit.

6. The method of claim 1, further including the step of:

displaying an error message to a user when a determination is made during the determining step, by comparing the at least one relationship to at least one predetermined threshold limit, that the PT signal data collected from the assay area is unacceptable.

7. The method of claim 1, wherein:

the collecting step includes collecting PT signal data from the assay area, a first control area and a second control area of the PT test strip;

the ascertaining step includes ascertaining a first relationship between PT signal data collected from the assay area and PT signal data collected from the first control area and ascertaining a second relationship between PT signal data collected from the assay area and PT signal data collected from the second control area, and

the determining step includes determining whether the PT signal data collected from the assay area is acceptable based on comparing the first relationship and the second relationship to predetermined threshold limits.

8. The method of claim 7, further including the step of:

displaying an error message to a user when a determination is made during the determining step that the PT signal data collected from the assay area is unacceptable based on the comparing of the first relationship and the second relationship to the predetermined threshold limits.

9. The method of claim 8, wherein the displaying step displays a first error message when a determination is made during the determining step that the PT signal data collected from the assay area is unacceptable based on the first relationship, displays a second error message when a determination is made during the determining step that the PT signal data collected from the assay area is unacceptable based on the second relationship, and displays a third error message when a determination is made during the determining step that the PT signal data collected from the assay area is unacceptable based on both the first and second relationships.

10. A method for determining the acceptability of signal data collected from a prothrombin time (PT) test strip, the method comprising:

collecting prothrombin time (PT) signal data from an assay area of a PT test strip, PT signal data from a first control area of the PT test strip and OT signal data from a second control area of the PT test strip;

ascertaining a first relationship between PT signal data collected from the assay area and PT signal data collected from the first control area and ascertaining a second relationship between PT signal data collected from the assay area and PT signal data collected from the second control area; and

determining, based on the first and second relationships, whether the PT signal data collected from the assay area is acceptable for use in accurately determining prothrombin time by comparing the first relationship and the second relationship to predetermined threshold limits,

wherein the first relationship is a ratio of a post-peak pseudo-slope of PT signal data from the assay area and a post-peak pseudo-slope of PT signal data from the first control area and the second relationship is a ratio of post-peak pseudo-slope of PT signal data from the assay area and a post-peak pseudo-slope of PT signal data from the second control area; and

wherein the predetermined threshold limits are based on PT signal data collected from standard reference PT test strips.

11. A prothrombin time (PT) monitoring system comprising:

a prothrombin time (PT) test strip that includes;

an assay area; and

at least one control area; and

a device that includes;

an optical measurement means for measuring an optical property of the assay area and the at least one control area;

an analog-to-digital converter module;

a microprocessor module; and

a memory module,

wherein the optical measurement means, analog-to-digital converter module, microprocessor module and memory module are adapted to;

collect prothrombin time (PT) signal data from the assay area and PT signal data from the at least one control area;

ascertain at least one relationship between PT signal data collected from the assay area and PT signal data collected from the at least one control area; and

determine, based on the at least one relationship, whether the PT signal data collected from the assay area is acceptable by comparing the first relationship to a predetermined threshold limit,

wherein the at least one relationship is selected from the relationship group consisting of a ratio of a post-peak pseudo-slope of PT signal data from the assay area and a post-peak pseudo-slope of PT signal data from at least one control area, a ratio of a peak width of PT signal data from the assay area and peak width of PT signal data from the at least one control area, and a ratio of an area underneath the PT signal data from the assay area and the area underneath the PT signal data from the at least one control area; and

wherein the predetermined threshold limit is based on PT signal data collected from standard reference PT test strips.

12. The PT monitoring system of claim 11, wherein the device further includes a display module and wherein the microprocessor module, memory module and display module are adapted to display an error message to a user when a determination has been made that the PT signal data collected from the assay area is unacceptable by comparing the first relationship and the second relationship to predetermined threshold limits.

13. The PT monitoring system of claim 11, wherein the PT test strip includes the assay area, a first control area and a second control area and wherein the optical measurement means, analog-to-digital converter module, microprocessor module and memory module are adapted to:

collect PT signal data from the assay area, the first control area and the second control area;

ascertain a first relationship between PT signal data collected form the assay area and PT signal data collected from the first control area and a second relationship between PT signal data collected from the assay area and PT signal data collected from the second control area; and

determine, based on the first and second relationships, whether the PT signal data collected from the assay area is acceptable by comparing the first relationship and the second relationship to predetermined threshold limits,

wherein the first relationship is a ratio of a post-peak pseudo-slope of PT signal data from the assay area and a post-peak pseudo-slope of PT signal data from the first control area and the second relationship is a ratio of post-peak pseudo-slope of PT signal data from the assay area and a post-peak pseudo-slope of PT signal data from the second control area.

14. The PT monitoring system of claim 11, wherein the device is a portable hand-held meter.

15. The PT monitoring system of claim 11, wherein the optical measurement means is an LED/photo-detector pair.