Method and system for determining the acceptability of signal data collected from a prothrombin time test strip
First Claim
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.
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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.
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Citations
22 Claims
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1. A method for determining the acceptability of signal data collected from a prothrombin time (PT) test strip, the method comprising:
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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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13)
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14. A method for determining the acceptability of signal data collected from a prothrombin time (PT) test strip, the method comprising:
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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 PT 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. - View Dependent Claims (15)
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16. A prothrombin time (PT) monitoring system comprising:
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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. - View Dependent Claims (17, 18, 19, 20, 21, 22)
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Specification