Test strip qualification system
First Claim
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 first control qualification criteria and results from said 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 prothrombin results; and
outputting a message to a user indicating test strip reliability.
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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.
185 Citations
17 Claims
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1. A method of test strip qualification, said method comprising:
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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 first control qualification criteria and results from said 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 prothrombin results; and
outputting a message to a user indicating test strip reliability. - View Dependent Claims (2, 3, 4, 5, 6, 7, 14, 15, 16, 17)
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8. A method of test strip qualification, said method comprising:
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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 first control qualification criteria and results from said 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 prothrombin results, said lower limit having first and second sections dependent upon assay reaction area prothrombin results, wherein said second section drops-off from said first section; and
outputting a message to a user indicating test strip reliability. - View Dependent Claims (9, 10, 11, 12, 13)
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Specification