Analytical test strip with capillary sample-receiving chambers separated by a physical barrier island

• US 9,128,038 B2
• Filed: 06/21/2012
• Issued: 09/08/2015
• Est. Priority Date: 06/21/2012
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: LifeScan Scotland Limited (Johnson & Johnson)
• Inventors: Whyte, Lynsey, Sloss, Scott, Mccoll, David, Whitehead, Neil, Smith, Antony
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US13/529,901
• Publication Number:
  US 20130341209A1
• Time in Patent Office: 1,174 Days
• Field of Search: 20440301-40315, 422400-402, 422/412, 422/413, 422/417, 422/419
• US Class Current: 1/1
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 3/502 with fluid transport, e.g. in multi-compartment structures centrifugal-type cuvettes G01N21/07; analysis by separation into components G01N30/00; automatic analysers G01N35/00
• 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 27/3274 Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/492 Determining multiple analytes

Abstract

An analytical test strip for the determination of an analyte (such as glucose and/or hematocrit) in a bodily fluid sample (such as a whole blood sample) includes a first capillary sample-receiving chamber, a second capillary sample-receiving chamber, and a physical barrier island disposed between the first and second capillary sample-receiving chambers. Moreover, the physical island barrier is disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber is prevented during use of the analytical test strip.

Claims

1. An analytical test strip for the determination of an analyte in a bodily fluid sample, the analytical test strip comprising:

an electrically insulating substrate layer;

at least one reference electrode and a plurality of working electrodes, all of which are disposed on the electrically insulating substrate layer;

an enzymatic reagent layer disposed over at least one of, but not all of the working electrodes;

a first capillary sample-receiving chamber;

a second capillary sample-receiving chamber;

a physical barrier island disposed between the first capillary sample-receiving chamber and the second capillary receiving chamber, and

wherein the physical island barrier is disposed such that bodily fluid sample flow between the first capillary sample-receiving chamber and the second capillary sample-receiving chamber during use of the analytical test strip is prevented.

2. The analytical test strip of claim 1 wherein the first capillary sample receiving chamber has at least one sample application opening and the second sample receiving chamber has at least one sample application opening, and

wherein the sample application opening of the first capillary sample-receiving chamber and the sample application opening of the second sample-receiving chamber are juxtaposed such that a single bodily fluid sample can be simultaneously applied thereto.

3. The analytical test strip of claim 1 wherein the first capillary sample-receiving chamber has a first sample application opening and a second sample application opening and wherein the second sample-receiving chamber has a first sample application opening and a second sample application opening.

4. The analytical test strip of claim 3 wherein the physical barrier island extends longitudinally along the first capillary sample-receiving chamber and the second capillary sample-receiving chamber.

5. The analytical test strip of claim 4 wherein the physical barrier island is disposed such that:

a first shared sample entry chamber is defined at the first sample application opening of the first capillary sample-receiving chamber and the first sample application opening of the second capillary-sample receiving chamber, and

a second shared sample entry chamber is defined at the second sample application opening of the first capillary sample-receiving chamber and the second sample application opening of the second capillary sample-receiving chamber.

6. The analytical test strip of claim 5 wherein a width of the first shared sample entry chamber is greater than the sum of widths of the first sample application opening of the first capillary sample-receiving chamber and the first sample application opening of the second capillary-sample receiving chamber, and

wherein a width of the second shared sample entry chamber is greater than the sum of widths of the second sample application opening of the first capillary sample-receiving chamber and the second sample application opening of the second capillary-sample receiving chamber.

7. The analytical test strip of claim 1 wherein the analytical test strip is configured as an electrochemical-based analytical test strip.

8. The analytical test strip of claim 1 wherein the bodily fluid sample is a whole blood sample.

9. The analytical test strip of claim 1 wherein the analyte is glucose.

10. The analytical test strip of claim 1 wherein the analyte is glucose and the analytical test strip is configured to determine the analyte in a bodily fluid sample introduced to the first capillary sample-receiving chamber and hematocrit of a bodily fluid sample introduced into the second capillary sample-receiving chamber.