Strips for analyzing samples

• US 7,144,485 B2
• Filed: 01/13/2003
• Issued: 12/05/2006
• Est. Priority Date: 01/13/2003
• Status: Active Grant

• Current Assignee: Hmd Biomedical Inc.
• Original Assignee: Hmd Biomedical Inc.
• Inventors: Lai, Chia-Te, Lin, Hang-Tang, Hsu, Tien-Tsai
• Primary Examiner(s): Noguerola, Alex
• Application Number:
  US10/341,713
• Publication Number:
  US 20040134779A1
• Time in Patent Office: 1,422 Days
• Field of Search: 2044034-40314, 204416-418, 204/411, 204/412, 204/400
• US Class Current: 204/403.02
• CPC Class Codes: B01L 2300/0645 Electrodes
• CPC Class Codes: B01L 2300/0825 Test strips
• CPC Class Codes: B01L 2300/0887 Laminated structure
• CPC Class Codes: B01L 2400/0406 capillary forces
• CPC Class Codes: B01L 3/508 rigid containers not provided for above
• CPC Class Codes: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

This invention relates to a strip for analyzing a sample. The strip includes two insulating layers, a spacer layer, and a conducting circuit. The spacer layer is disposed between the two insulating layers, and configured to define, together with the two insulating layers, an adsorption port, a sample chamber, a capillary for delivering a sample from the adsorption port to the sample chamber through the capillary, and a vent for facilitating delivery of the sample into the sample chamber. The conducting circuit, also disposed between the two insulating layers, includes a working electrode, a counter electrode, conducting wires, and connectors. A test agent, reactive to an analyte in a sample, is in association with the electrodes.

Claims

1. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has a side edge and a rear edge, the adsorption port being disposed at the side edge, and the connectors being disposed at the rear edge;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

2. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

wherein the sample chamber is filled with a hydrophilic material, the strip is a pentagon in the shape of a rectangle having a clipped angle and has a front edge and a rear edge, first and second side edges, and a slanting edge, corresponding to the clipped angle, between the front edge and the first side edge;

the spacer layer, together with the first and second insulating layers, further defines a second adsorption port and a second capillary for delivering a sample from the second adsorption port to the sample chamber through the second capillary;

the connectors are disposed at the rear edge;

the first and second adsorption ports are disposed at the second side

edge and the slanting edge, respectively; and

only one of the first and second insulating layers

has a second indentation at the second adsorption port, which is defined by the second indentation, the other insulating layer, and the spacer layer;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

3. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

wherein the sample chamber is filled with a hydrophilic material, the strip is a hexagon in the shape of a rectangle having two clipped angles and has a front edge and a rear edge, first and second side edges, and first and second slanting edges, corresponding to the two clipped angles, between the front edge and the first side edge and between the front edge and the second side edge, respectively;

the spacer layer, together with the first and second insulating layers, further defines a second adsorption port and a second capillary for delivering a sample from the second adsorption port to the sample chamber through the second capillary;

the connectors are disposed at the rear edge;

the first and second adsorption ports are disposed at the first and second slanting edges, respectively; and

only one of the first and second insulating layers has a second indentation at the second adsorption port, which is defined by the second indentation, the other insulating layer, and the spacer layer;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

4. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has first and second side edges and a rear edge;

the spacer layer, together with the first and second insulating layers, further defines a second adsorption port and a second capillary for delivering a sample from the second adsorption port to the sample chamber through the second capillary;

the first and second adsorption ports are disposed at the first and second side edges, respectively;

the connectors are disposed at the rear edge; and

only one of the first and second

insulating layers has a second indentation at the second adsorption port, which is defined by the second indentation, the other insulating layer, and the spacer layer;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

5. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the

conducting circuit having a working electrode, a counter electrode and connectors;

at least a

portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has a front edge and a rear edge, and first and second side edges;

the spacer layer, together

with the first and second insulating layers, further defines second and third adsorption ports, and second and third capillaries for delivering a sample from the second and third adsorption ports to the sample chamber through the second and third capillaries, respectively;

the first, second, and third adsorption ports are disposed at the front edge, the first side edge, and the second side edge, respectively;

the connectors are disposed at the rear edge;

only one of the first and second

insulating layers has a second indentation at the second adsorption port, which is defined by the second indentation, the other insulating layer, and the spacer layer; and

only one of the first and second insulating layers has a third indentation at the third adsorption port, which is defined by the third indentation, the other insulating layer, and the spacer layer;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

6. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

the conducting circuit further comprising an indicator electrode, disposed between the first and second insulating layers and electrically connected to one of the connectors, to indicate that the sample chamber is filled with a sample when the sample contacts both the indicator electrode and the counter electrode, the indicator electrode being positioned at an end of the sample chamber distal to the adsorption port;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has a side edge and a rear edge, the adsorption port is disposed at the side edge, and the connectors are disposed at the rear edge;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

7. The strip of claim 6, wherein the indicator electrode and the working electrode are printed on the first insulating layer and the counter electrode is printed on the second insulating layer, and the second insulating layer has a hole in communication with the sample chamber to form a vent.

8. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein

the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

the conducting circuit further comprising an indicator electrode, disposed between the first and second insulating layers and electrically connected to one of the connectors, to indicate that the sample chamber is filled with a sample when the sample contacts both the indicator electrode and the counter electrode, the indicator electrode being positioned at an end of the sample chamber distal to the adsorption port;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has a front edge and a rear edge, the adsorption port is disposed at the front edge, the connectors are disposed at the rear edge, the indicator electrode and the working electrode are printed on the first insulating layer and the counter electrode is printed on the second insulating layer, and the second insulating layer has a hole in communication with the sample chamber to form a vent;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

9. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter the conducting circuit further comprising a second working electrode, disposed between the first and second insulating layers and electrically connected to one of the connectors, to measure the conductivity of a sample when the sample contacts both the second working electrode and the counter electrode, at least a portion of the second working electrode being placed in the capillary;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has a rear edge and first and second side edges;

the spacer layer, together with the first and second insulating layers, further defines a second adsorption port and a second capillary for delivering a sample from the second adsorption port to the sample chamber through the second capillary;

a second portion of the second working electrode is disposed at the second capillary distal to the first adsorption port so that the second working electrode first indicates that a sample enters the first capillary when the sample contacts both the first portion of the second working electrode in the first capillary and the counter electrode, and then indicates that the sample chamber is filled with the sample when the sample contacts both the second portion of the second working electrode in the second capillary and the counter electrode;

the first and second adsorption ports are disposed at the first and second side edges, respectively;

the connectors are

disposed at the, rear edge; and

only one of the first and second insulating layers has a second

indentation at the second adsorption port, which is defined by the second indentation, the other insulating layer, and the spacer layer;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample, containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

10. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

the conducting circuit further comprising a second working electrode, disposed between the first and second insulating layers and electrically connected to one of the connectors, to measure the conductivity of a sample when the sample contacts both the second working electrode and the counter electrode, at least a portion of the second working electrode being placed in the capillary;

the conducting circuit further comprising an indicator electrode, printed on the first insulating layer and electrically connected to one of the connectors, to indicate that the sample chamber is filled with a sample when the sample contacts both the indicator electrode and the counter electrode, the indicator electrode being positioned at an end of the sample chamber distal to the adsorption port;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has a front edge and a rear edge;

the adsorption port is disposed at the front edge;

the connectors are disposed at the rear edge;

the first and second working electrodes are printed on the first insulating layer and the counter electrode is printed on the second insulating layer; and

the second insulating layer has a hole in communication with the sample chamber to form a vent;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

11. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

the conducting circuit further comprising a second working electrode, disposed between the first and second insulating layers and electrically connected to one of the connectors, to measure the conductivity of a sample when the sample contacts both the second working electrode and the counter electrode, at least a portion of the second working electrode being placed in the capillary;

the conducting circuit further comprising an indicator electrode, printed on the first insulating layer and electrically connected to one of the connectors, to indicate that the sample chamber is filled with a sample when the sample contacts both the indicator electrode and the counter electrode, the indicator electrode being positioned at an end of the sample chamber distal to the adsorption port;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has a side edge and a rear edge;

the adsorption port is disposed at the side edge;

the connectors are disposed at the rear edge;

the working electrode is printed on the first insulating layer and the counter electrode is printed on the second insulating layer; and

the second insulating layer has a hole in communication with the sample chamber to form a vent;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

12. A strip for analyzing a sample comprising:

a first insulating layer;

a second insulating layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, an adsorption port, a sample chamber, and a capillary for delivering a sample from the adsorption port to the sample chamber;

wherein the adsorption port is outwardly enlarged from the capillary and only one of the first and second insulating layers has an indentation at the adsorption port, which is defined by the indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connector being electrically connected to the working electrode and the counter electrode, and being adapted for electrical connection to a meter capable of measuring an electrical parameter;

the conducting circuit further comprising a second working electrode, disposed between the first and second insulating layers and electrically connected to one of the connectors, to measure the conductivity of a sample when the sample contacts both the second working electrode and the counter electrode, at least a portion of the second working electrode being placed in the capillary;

the conducting circuit further comprising an indicator electrode and a third working electrode, both printed on the first insulating layer and electrically connected to two of the connectors, respectively;

wherein the sample chamber is filled with a hydrophilic material, the strip is a rectangle and has a front edge and a rear edge and first and second side edges;

the spacer layer, together with the first and second insulating layers, further defines a second sample chamber so that a sample can be delivered from the adsorption port to the first and second sample chambers through the capillary;

the adsorption port is disposed at the front edge;

the connectors are disposed at the rear edge;

the first and second working electrodes are printed on the first insulating layer;

the counter electrode is printed on the second insulating layer and two portions of the counter electrode are placed in the capillary and the second sample chamber, respectively;

a first portion of the indicator electrode is placed in the capillary and two other portions of the indicator electrode are placed at an end of the first sample chamber and at an end of the second sample chamber, to first indicate that a sample enters the capillary when the sample contacts the first portion of the indicator electrode and the portion of the counter electrode in the capillary, and then indicate that the first and second sample chambers are filled with the sample when the sample contacts the two other portions of the indicator electrode; and

at least a portion of the third working electrode is in association with a second test agent reactive to a second analyte and is placed in the second sample chamber, whereby a second analyte-responsive signal is generated and transmitted to the meter when a sample containing the second analyte enters the second sample chamber and contacts both the third working electrode and the portion of the counter electrode in the second sample chamber;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

13. A strip for analyzing a sample, comprising:

a first side edge, a second side edge, a front edge, and a rear edge;

a first insulating layer and a second insulting layer;

a spacer layer disposed between the first and second insulating layers, and configured to define, together with the first and second insulating layers, a first adsorption port disposed at the first side edge, a second adsorption port disposed at the second side edge, a sample chamber, a first capillary, and a second capillary, wherein either the first capillary is adapted for delivering a sample from the first adsorption port to the sample chamber or the second capillary is adapted for delivering a sample from the second adsorption port to the sample chamber, only one of the first and second insulating layers has a first indentation at the first adsorption port, which is defined by the first indentation, the other insulating layer, and the spacer layer; and

only one of the first and second insulating layers has a second indentation at the second adsorption port, which is defined by the second indentation, the other insulating layer, and the spacer layer; and

a conducting circuit also disposed between the first and second insulating layers;

the conducting circuit having a working electrode, a counter electrode, and connectors;

at least a portion of the working electrode and the counter electrode being in association with a test agent reactive to an analyte and placed in the sample chamber;

the connectors being disposed at the rear edge, electrically connected to the working electrode and the counter electrode, and adapted for electrical connection to a meter capable of measuring an electrical parameter;

whereby an analyte-responsive signal is generated and transmitted to the meter when a sample containing the analyte enters the sample chamber and contacts both the working electrode and the counter electrode.

14. The strip of claim 13, wherein the first and second adsorption ports are symmetrically disposed at the first and second side edges.

15. The strip of claim 13, wherein the sample chamber is filled with a hydrophilic material.