Determining usability of analytical test strip

• US 9,879,302 B2
• Filed: 01/21/2016
• Issued: 01/30/2018
• Est. Priority Date: 12/23/2013
• Status: Active Grant

• Current Assignee: LifeScan IP Holdings, LLC
• Original Assignee: Cilag Gmbh International (Johnson & Johnson)
• Inventors: Elder, David, Welsh, Raymond, McColl, David, Pati, Prasanta, Magennis, Ryan
• Primary Examiner(s): Brown, Melanie Yu
• Application Number:
  US15/002,552
• Publication Number:
  US 20160138075A1
• Time in Patent Office: 740 Days
• CPC Class Codes: C12Q 1/26 involving oxidoreductase
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875

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.

Claims

1. A method for the determination of an analyte in a bodily-fluid sample, the method comprising:

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.