Error detection and rejection for a diagnostic testing system
Inventors
Modzelewski, Brent E. • Kayihan, Ferhan • Cardello, Edward
Assignees
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Abstract
A system for measuring a property of a sample is provided. The system comprises a diagnostic measuring device having a memory and a diagnostic test strip for collecting the sample. The strip has embedded thereon a pattern representative of at least first data and second data, the first data being data representing at least one of parameters related to measuring the property, codes usable for calibration of the diagnostic measuring device, or parameters indicating proper connection between the measuring device and the test strip and the second data usable for detecting and rejecting potential errors affecting the proper measurement of the property.
Core Innovation
The invention relates to an electrochemical diagnostic system that uses a diagnostic test strip having two or more contacting pads. Each contacting pad has a predefined electrical conductivity, and the electrical conductivities of the contacting pads form a code that represents information particular to the test strip. A diagnostic measuring device receives the test strip, reads the code particular to the test strip, and measures a sample.
A processor in the diagnostic measuring device executes an error detection routine for detecting errors in the code. The routine compares the read code to a predetermined set of acceptable codes indicative of no error or acceptable level of error, and indicates an error if the code particular to the test strip is not in the predetermined set. The predetermined set of acceptable codes is reduced by excluding one or more code values having a probability of being misread due to a defect associated with one or more contacting pads.
The disclosed code checking approach extends to code value and unit value representations. The code can be formed as a combination of unit values from multiple units, where unit values can be represented by digital bits, analog readings, symbols, or pictograms. The system further supports selectively excluding misread-prone code/value combinations based on misread probability associated with contacting pad defects, and includes an optional error correction using Hamming code with added check bits on the strip.
The description also includes constraints for auto-on or wake-up behavior related to the code space, including exclusion of all-zero or all-insulators inactive code. It further includes mechanisms for error detection and rejection based on comparing expected versus observed code/lot characteristics over time, checksum-style rejection computed from encoded code bits with checksum bits encoded differently, and redundant code reading using differently ordered or differently encoded code iterations to require matching.
Claims Coverage
This document contains two independent claims covering (i) an electrochemical diagnostic system with strip-specific coded contacting pads and code-error detection based on a reduced acceptable code set, and (ii) a method determining a constituent level in a fluid by performing the same code error detection and rejection before determining the constituent level. Across the independent claims, the inventive core includes reading strip code formed from pad conductivities, comparing the read code to a predetermined reduced acceptable set based on misread probability due to pad defects, and indicating an error when the code is not acceptable.
Strip-specific conductivity code from contacting pads
A diagnostic test strip includes two or more contacting pads, each contacting pad having a predefined electrical conductivity, wherein the electrical conductivity of the two or more contacting pads form a code that represents information particular to the test strip.
Code reading and sample measuring by a diagnostic measuring device
A diagnostic measuring device receives the test strip, reads the code particular to the test strip, and measures the sample.
Error detection by comparing to a reduced acceptable code set
The diagnostic measuring device executes an error detection routine for detecting errors in the code by comparing the code to a predetermined set of acceptable codes indicative of no error or acceptable level of error, wherein the predetermined set of acceptable codes is reduced by excluding predetermined one or more codes having a probability of being misread due to a defect associated with one or more contacting pads.
Error indication when code is outside acceptable set
The diagnostic measuring device indicates an error if the code particular to the test strip is not in the predetermined set of acceptable codes.
Constituent level determining only after error detection and rejection
A method determines a constituent level within a fluid by providing a diagnostic test meter and test strip with coded contacting pads, inserting the test strip into the test meter to read the at least one code, performing an error detection and rejection algorithm on the at least one code by comparing to a predetermined reduced set of acceptable codes and indicating an error if the code is not acceptable, and determining the constituent level if the algorithm does not detect an error.
The independent claims are centered on strip-specific coding formed from predefined contacting-pad conductivities, device reading of that code, and processor-driven error detection that compares the read code to a reduced predetermined set of acceptable codes determined by misread probability due to contacting-pad defects, with error indication and constituent-level determination contingent on successful error detection and rejection.
Stated Advantages
Improved error detection by using a predetermined set of acceptable codes reduced by excluding misread-prone codes due to defects associated with contacting pads.
Enables error indication when the strip code is not in the predetermined set of acceptable codes.
Constituent level determination is performed only if the error detection and rejection algorithm does not detect an error.
Documented Applications
Measuring a property of a sample using a diagnostic test strip and diagnostic measuring device that read strip-specific code and perform error detection and rejection before measurement.
Determining a constituent level within a fluid by reading a code from a diagnostic test strip, performing error detection and rejection, and determining the constituent level only when no error is detected.
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