Electronic lateral flow test arrangement and method

• US 9,921,228 B2
• Filed: 12/06/2012
• Issued: 03/20/2018
• Est. Priority Date: 12/07/2011
• Status: Active Grant

• Current Assignee: NXP B.V. (NXP Semiconductors NV)
• Original Assignee: NXP B.V. (NXP Semiconductors NV)
• Inventors: Nguyen, Viet, Widdershoven, Franciscus Petrus, Daamen, Roel
• Primary Examiner(s): Crawford, Erik B
• Application Number:
  US14/363,449
• Publication Number:
  US 20140323350A1
• Time in Patent Office: 1,930 Days
• Field of Search: None
• 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 33/5438 Electrodes
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads

Abstract

A lateral test flow arrangement for a test molecule is disclosed, comprising: a test strip for transporting an analyte away from a sampling region and towards an absorbing region, the test strip having therein and remote from the sampling region, a test region for functionalization with a molecule which binds to the test molecule or to a conjugate of the test molecule; a sensing test capacitor having electrodes extending across the test strip at least partially aligned with the test region and being physically isolated therefrom; a reference test capacitor having electrodes extending across the test strip and being physically isolated therefrom; and an electronic circuit configured to measure a time-dependant capacitance difference between the sensing test capacitor and the reference test capacitor. A method for carrying out that lateral flow tests is also disclosed, as are test systems and in particular pregnancy test systems.

Claims

1. A lateral flow test arrangement for at least one test molecule comprising:

a test strip for transporting an analyte having the at least one test molecule away from a sampling region and towards an absorbing reservoir region, the test strip having therein and remote from the sampling region, a test region for functionalization with a molecule which binds to the at least one test molecule or to a conjugate of the at least one test molecule;

a sensing test capacitor in the test region, the sensing test capacitor having a dielectric material having a dielectric permittivity influenced by the presence of marker molecules, having a first pair of electrodes configured to measure a first capacitance, and extending across the test strip at least partially aligned with the test region;

a reference test capacitor near the test region, having a second pair of electrodes configured to measure a second capacitance, and extending across the test strip; and

an electronic circuit configured to measure a time-dependant capacitance difference between the capacitances of the sensing test capacitor and the reference test capacitor,

wherein the test strip further includes a control region for functionalization with a second molecule different from the molecule in the test region, the lateral flow test arrangement further including a sensing control capacitor having a third pair of electrodes extending across the test strip at least partially aligned with the control region and extending across the test strip; and

a reference control capacitor having a fourth pair of electrodes extending across the test strip,

wherein the electronic circuit is further configured to measure a time-dependant capacitance difference between the sensing control capacitor and the reference control capacitor.

2. The lateral flow test arrangement according to claim 1, wherein at least one of:

the first pair of electrodes of the sensing test capacitor are both on the same side of the test strip, and the second pair of electrodes of the reference test capacitor are both on the same side of the test strip.

3. The lateral flow test arrangement according to claim 1, wherein the first pair of electrodes of the sensing test capacitor and the second pair of electrodes of the reference test capacitor comprise conducting tracks in a substrate flex-foil, and the substrate flex-foil is arranged to provide electrical isolation between the first and second pair of electrodes and the test strip.

4. The lateral flow test arrangement according to claim 1, wherein the electronic circuit is further configured to measure the capacitance of at least one of the sensing test capacitor and the reference test capacitor at a plurality of frequencies.

5. The lateral flow test arrangement according to 4, wherein the electronic circuit is further configured to determine a volume flow rate from the time-dependant capacitance difference between the sensing control capacitor and the reference control capacitor and the time-dependant capacitance difference between the capacitance of the sensing test capacitor and the capacitance of the reference test capacitor.

6. The lateral flow test arrangement according to claim 1, further comprising a data display for displaying data from the electronic circuit.

7. The lateral flow test arrangement according to claim 1, further comprising communication circuit for communicating data from the electronic circuit to an external device.

8. The lateral flow test arrangement according to claim 1, the test strip having there across and remote from the sampling region, a further test line for functionalization with a further molecule which binds to the further at least one test molecule;

the lateral flow test arrangement test further comprising;

a further sensing test capacitor having a fifth pair of electrodes longitudinally aligned with the test line and extending across the test strip;

a further reference test capacitor having a sixth pair of electrodes extending across the test strip,

wherein the electronic circuit is further configured to measure a time-dependant capacitance difference between the further sensing test capacitor and the further reference test capacitor.

9. The lateral flow test arrangement according to claim 1, wherein the lateral flow test arrangement is configured to monitor a concentration of a target molecule or molecules of the at least one molecule in the analyte.

10. The lateral flow test arrangement according to claim 8, wherein the lateral flow test arrangement is configured to monitor a concentration of a plurality of different target molecules in the analyte.

11. The lateral flow test arrangement according to claim 9, wherein the target molecule or molecules may be is a respective one of or a plurality of molecules from the set consisting of DNA, proteins, enzymes, peptides, cells, bacteria, small molecules and hormones.

12. The lateral flow test arrangement according to claim 1, wherein the first pair of electrodes includes conductive plates with interdigitated fingers to increase the capacitance between the conductive plates.

13. The lateral flow test arrangement according to claim 1, wherein the second pair of electrodes includes conductive plates with interdigitated fingers to increase the surface area of the conductive plates.

14. The lateral flow test arrangement according to claim 1, wherein the reference test capacitor is not significantly affected by the presence of the marker molecules in the test region.

15. A pregnancy test system including a lateral flow test arrangement for at least one test molecule comprising:

a test strip for transporting an analyte having the at least one test molecule away from a sampling region and towards an absorbing reservoir region, the test strip having therein and remote from the sampling region, a test region for functionalization with a molecule which binds to the at least one test molecule or to a conjugate of the at least one test molecule;

a sensing test capacitor in the test region, the sensing test capacitor having a dielectric material having a dielectric permittivity influenced by the presence of marker molecules, having a first pair of electrodes configured to measure a first capacitance, and extending across the test strip at least partially aligned with the test region;

a reference test capacitor near the test region, having a second pair of electrodes configured to measure a second capacitance, and extending across the test strip; and

an electronic circuit configured to measure a time-dependant capacitance difference between the capacitances of the sensing test capacitor and the reference test capacitor,

wherein the test strip further includes a control region for functionalization with a second molecule different from the molecule in the test region, the lateral flow test arrangement further including a sensing control capacitor having a third pair of electrodes extending across the test strip at least partially aligned with the control region and extending across the test strip; and

a reference control capacitor having a fourth pair of electrodes extending across the test strip,

wherein the electronic circuit is further configured to measure a time-dependant capacitance difference between the sensing control capacitor and the reference control capacitor.