DETERMINING USABILITY OF ANALYTICAL TEST STRIP
First Claim
1. A system for determining usability of an analytical test strip, the system comprising:
- a) the analytical test strip having a sample chamber adapted to receive a fluid sample, a reagent arranged at least partly in the sample chamber, and two spaced-apart detection electrodes in contact with the reagent, wherein the reagent has an impedance that varies with moisture content; and
b) a test meter adapted to receive the analytical test strip, the test meter having an impedance-measurement circuit configured to apply an alternating-current waveform across the reagent via the detection electrodes and concurrently measure an impedance of the reagent, and having a processor configured to automatically determine whether the measured impedance of the reagent meets a selected dryness criterion.
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Accused Products
Abstract
A system for determining usability of an analytical test strip includes a sample chamber to receive a fluid sample, a reagent in the sample chamber having a moisture-varying impedance, and two detection electrodes contacting the reagent. A test meter applies an AC waveform across the reagent via the detection electrodes while measuring an impedance of the reagent. A processor automatically determines whether the measured impedance of the reagent meets a dryness criterion. The meter includes a housing, a strip port connector, an impedance measurement circuit and the processor. A method for determining usability of a strip inserted in a hand held meter includes applying an AC waveform across a reagent of the strip and measuring a first electrical signal, and determining whether the strip meets the dryness criterion based on the first electrical signal. The test strip and ways of determining an analyte are also described.
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Citations
22 Claims
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1. A system for determining usability of an analytical test strip, the system comprising:
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a) the analytical test strip having a sample chamber adapted to receive a fluid sample, a reagent arranged at least partly in the sample chamber, and two spaced-apart detection electrodes in contact with the reagent, wherein the reagent has an impedance that varies with moisture content; and b) a test meter adapted to receive the analytical test strip, the test meter having an impedance-measurement circuit configured to apply an alternating-current waveform across the reagent via the detection electrodes and concurrently measure an impedance of the reagent, and having a processor configured to automatically determine whether the measured impedance of the reagent meets a selected dryness criterion. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A hand-held test meter for use with an analytical test strip, the test meter comprising:
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a) a housing; b) a strip port connector configured to receive the analytical test strip and to electrically connect to two spaced-apart detection electrodes of the received analytical test strip; c) an impedance-measurement circuit arranged in the housing and configured to apply an alternating-current waveform across a reagent in a sample chamber of the received analytical test strip via the strip port connector, and to concurrently measure an impedance of the reagent; and d) a processor configured to automatically determine whether the measured impedance of the reagent meets a selected dryness criterion. - View Dependent Claims (13, 14, 15, 16)
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17. A method for determining usability of an analytical test strip inserted in a hand-held test meter, the method comprising performing the following steps using a processor and at least one electrical circuit of the test meter:
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applying an alternating-current waveform across a reagent of the inserted analytical test strip and measuring a first electrical signal; and determining whether the inserted analytical test strip meets a selected dryness criterion based on the first electrical signal. - View Dependent Claims (18, 19, 20)
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21. An electrochemical-based analytical test strip comprising:
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a) an electrically-insulating bottom layer; b) a patterned electrically-conductive layer disposed on the electrically insulating bottom layer that includes a first patterned portion and a second patterned portion; c) an enzymatic reagent layer disposed on the first patterned portion, the second patterned portion and the electrically-insulating bottom layer such that the enzymatic reagent layer bridges the first patterned portion and the second patterned portion; d) a patterned spacer layer; e) a top electrically conductive layer; and f) an electrically-insulating top layer.
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22. A method for the determination of an analyte in a bodily-fluid sample, the method comprising:
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ascertaining whether an enzymatic reagent layer of an electrochemical-based analytical test strip has been exposed to a predetermined humidity level by measuring an electrical characteristic of the enzymatic reagent layer, the electrochemical-based analytical test strip having; an electrically-insulating bottom layer; a patterned electrically-conductive layer disposed on the electrically insulating bottom layer and including a first patterned portion and a second patterned portion; an enzymatic reagent layer disposed on the first patterned portion, the second patterned portion and the electrically-insulating bottom layer such that the enzymatic reagent layer bridges the first patterned portion and the second patterned portion; a patterned spacer layer; a top electrically conductive layer; and an electrically-insulating top layer; applying the bodily-fluid sample to the electrochemical-based analytical test strip; and determining the analyte based on an electrochemical response of the electrochemical-based analytical test strip.
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Specification