Control markers for auto-detection of control solution and method of use
First Claim
1. A method of distinguishing a control solution from a sample during operation of an electrochemical test sensor measuring the amount of an analyte in the control solution and in the sample, the method comprising the acts of:
- (a) adding to the control solution a control marker, the control marker being adapted to be electrochemically oxidized at a potential higher than the potential needed to measure the oxidation of the analyte, the control marker including sodium iodide, triethanolamine, tripropanolamine, tributanolamine, 2,5-dihydroxybenzoic acid, xylenol orange, hydroquinone sulfonic acid, cresol red, 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-aminosalicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS), 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid (TOO S), 8-anilino-1-naphthalenesulfonic acid, 8-anilino-1-naphthalenesulfonic acid, 2-napthylamine 1-sulfonic acid, sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or salts thereof,(b) introducing the control solution, the control marker and a predetermined amount of the analyte to the electrochemical test sensor, the test sensor including a first electrode, a second electrode and a reagent;
(c) at least once applying a potential to the test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current;
(d) at least once applying a potential to the electrochemical test sensor lower than the potential of (c), the potential being sufficient to measure oxidation of the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and
(e) determining whether a control solution or a sample is present based on the measured electrical currents.
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Accused Products
Abstract
A method of distinguishing a control solution from a sample in an electrochemical test sensor is performed. The method includes adding a control marker to the control solution. The control solution includes the control marker and analyte. The test sensor includes working and counter electrodes, and a reagent. A potential is applied to the test sensor to oxidize the control marker and the analyte. The resulting electrical current is measured. A potential is applied to the test sensor lower than the other potential in which the potential is sufficient to oxidize the analyte and not the control marker. The resulting electrical current is measured. Determining whether a control solution or a sample is present based on the measured electrical currents. To increase the measured current, a salt may be added to the control solution in an amount sufficient to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt.
43 Citations
41 Claims
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1. A method of distinguishing a control solution from a sample during operation of an electrochemical test sensor measuring the amount of an analyte in the control solution and in the sample, the method comprising the acts of:
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(a) adding to the control solution a control marker, the control marker being adapted to be electrochemically oxidized at a potential higher than the potential needed to measure the oxidation of the analyte, the control marker including sodium iodide, triethanolamine, tripropanolamine, tributanolamine, 2,5-dihydroxybenzoic acid, xylenol orange, hydroquinone sulfonic acid, cresol red, 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-aminosalicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS), 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid (TOO S), 8-anilino-1-naphthalenesulfonic acid, 8-anilino-1-naphthalenesulfonic acid, 2-napthylamine 1-sulfonic acid, sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or salts thereof, (b) introducing the control solution, the control marker and a predetermined amount of the analyte to the electrochemical test sensor, the test sensor including a first electrode, a second electrode and a reagent; (c) at least once applying a potential to the test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current; (d) at least once applying a potential to the electrochemical test sensor lower than the potential of (c), the potential being sufficient to measure oxidation of the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and (e) determining whether a control solution or a sample is present based on the measured electrical currents. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A control solution for use in testing an electrochemical system for measuring the amount of an analyte in a sample, the control solution comprising:
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(a) a predetermined amount of the analyte; and (b) a predetermined amount of a control marker, the control marker being adapted to be oxidized at a potential higher than the potential required to oxidize the analyte, the control marker including sodium iodide, triethanolamine, tripropanolamine, tributanolamine, 2,5-dihydroxybenzoic acid, xylenol orange, hydroquinone sulfonic acid, cresol red, 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-aminosalicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS), 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid (TOOS), 8-anilino-1-naphthalenesulfonic acid, 8-anilino-1-naphthalenesulfonic acid, 2-napthylamine 1-sulfonic acid, sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or salts thereof, the predetermined amount of the control marker being proportional to the predetermined amount of analyte such that the presence of the control marker is detectable. - View Dependent Claims (13, 14, 15, 16, 17, 18)
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19. A method of distinguishing a control solution from a sample during operation of an electrochemical test sensor, the electrochemical test sensor measuring the information related to an analyte, the method comprising the acts of:
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providing a control solution including an control marker and a predetermined amount of analyte, the control marker having a higher potential than the potential needed to measure the oxidation of the analyte, the control marker including sodium iodide, triethanolamine, tripropanolamine, tributanolamine, 2,5-dihydroxybenzoic acid, xylenol orange, hydroquinone sulfonic acid, cresol red, 3-[4-(hydroxyphenyl)amino]-3-oxopropanoic acid, N-acetyl-5-aminosalicyclic acid, N-ethyl-N-(3-sulfopropyl)-3-methylaniline (TOPS), 3-(N-ethyl-3-methylanilino)-2-hydroxypropanesulfonic acid (TOOS), 8-anilino-1-naphthalenesulfonic acid, 8-anilino-1-naphthalenesulfonic acid, 2-napthylamine 1-sulfonic acid, sodium diphenylamine-4-sulfonate, N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethylaniline (MAOS), or salts thereof; providing an electrochemical test sensor having a first electrode, a second electrode and a reagent; introducing the control solution to the electrochemical test sensor; applying a potential to the electrochemical test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current; applying a lower potential to the electrochemical test sensor, the lower potential being sufficient to oxidize the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and determining whether a control solution or a sample is present based on the measured electrical currents.
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20. A method of distinguishing a control solution from a sample during operation of an electrochemical test sensor measuring the amount of an analyte in the control solution and in the sample, the method comprising the acts of:
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(a) adding to the control solution a control marker, the control marker being adapted to be electrochemically oxidized at a potential higher than the potential needed to measure the oxidation of the analyte; (b) introducing the control solution, the control marker and a predetermined amount of the analyte to the electrochemical test sensor, the test sensor including a working electrode, a counter electrode and a reagent, the control solution including a sufficient amount of anionic polymer to increase the electrical current by at least 5% as compared to a control solution in the absence of an anionic polymer; (c) at least once applying a potential to the test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current; (d) at least once applying a potential to the electrochemical test sensor lower than the potential of (c), the potential being sufficient to measure oxidation of the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and (e) determining whether a control solution or a sample is present based on the measured electrical currents. - View Dependent Claims (21, 22, 23, 24, 25, 26)
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27. A method of distinguishing a control solution from a sample during operation of an electrochemical test sensor measuring the amount of an analyte in the control solution and in the sample, the method comprising the acts of:
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(a) adding to the control solution a control marker, the control marker being adapted to be electrochemically oxidized at a potential higher than the potential needed to measure the oxidation of the analyte, (b) introducing the control solution, the control marker and a predetermined amount of the analyte to the electrochemical test sensor, the test sensor including a working electrode, a counter electrode and a reagent, the control solution including a sufficient amount of salt to increase the electrical current by at least 5% as compared to a control solution in the absence of a salt to increase the measured current; (c) at least once applying a potential to the test sensor sufficient to oxidize the control marker and the analyte, and measuring the resulting electrical current; (d) at least once applying a potential to the electrochemical test sensor lower than the potential of (c), the potential being sufficient to measure oxidation of the analyte and not sufficient to oxidize the control marker, and measuring the resulting electrical current; and (e) determining whether a control solution or a sample is present based on the measured electrical currents. - View Dependent Claims (28, 29, 30, 31, 32, 33, 34)
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35. A method of determining the concentration of an analyte in a fluid sample, the method comprising the acts of:
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introducing the fluid sample to a test sensor; transferring at least one electron from the analyte in the sample to a mediator in the test sensor; applying a pulse sequence to the sample, the pulse sequence comprising at least two duty cycles within 180 seconds, at least one of the duty cycles having a first potential in a first excitation period and a first relaxation period, and after one of the duty cycles, providing a second potential to the sample, the second potential being greater than the first potential, the second potential being supplied after a second relaxation period, the second relaxation period being less than the first relaxation period; analyzing a current responsive to the excitation of the measurable species; and determining whether a control solution or a sample is present based on the measured electrical currents. - View Dependent Claims (36, 37, 38)
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39. A method of determining the concentration of an analyte in a fluid sample, the method comprising the acts of:
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introducing the fluid sample to a test sensor; transferring at least one electron from the analyte in the sample to a mediator in the test sensor; applying a higher voltage to the fluid sample; measuring a first current value of the fluid sample at the higher voltage; measuring a second current value of the fluid sample at a lower voltage; comparing the first current value to a number so as to determine if the sample is blood; if the comparison using the first current value does not result in determining whether the sample is blood, then using at least a first current value at the higher voltage and a second current value at a lower voltage to determine whether a control solution or a fluid sample is present. - View Dependent Claims (40, 41)
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Specification