Assay reader, device and method of measuring HCG

• US 9,851,364 B2
• Filed: 06/03/2009
• Issued: 12/26/2017
• Est. Priority Date: 06/04/2008
• Status: Active Grant

• Current Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Original Assignee: Alere Switzerland GmbH (Abbott Laboratories Incorporated)
• Inventors: Ellis, Jayne, Marshall, Jayne, Sharrock, Stephen P.
• Primary Examiner(s): Crawford, Erik B
• Application Number:
  US12/996,197
• Publication Number:
  US 20120021531A1
• Time in Patent Office: 3,128 Days
• Field of Search: 436 65, 436510, 436814, 436815, 436817, 436818
• CPC Class Codes: G01N 2021/8488 the band presenting reference patches
• CPC Class Codes: G01N 21/8483 Investigating reagent band test-element handling not specific to a test method G01N33/4875; analytical elements specific to chemical analysis of biological material G01N33/52; autometer with reagent band G01N35/04
• CPC Class Codes: G01N 2333/59 Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
• CPC Class Codes: G01N 33/54386 Analytical elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/689 related to pregnancy or the gonads
• CPC Class Codes: G01N 33/76 Human chorionic gonadotropin including luteinising hormone, follicle stimulating hormone, thyroid stimulating hormone or their receptors

Abstract

Disclosed is a method for determining a quantitative estimate of the length of time since conception in a female mammalian subject, the method comprising: a) providing a liquid sample suspected of containing hCG; b) measuring, by means of an assay or assay device, an analyte measurement signal, whose value is dependent upon the level of hCG; c) comparing the measured signal value to an analyte threshold, wherein said analyte threshold corresponds to a time since conception; d) providing an quantitative estimate of the length of time since conception based upon the comparison in step (c).

Claims

1. An electronic pregnancy test device for calculating a quantitative estimate of the length of time since conception in a female mammalian subject, the device comprising:

a) a first assay flow-path, comprising a mobilizable labeled binding reagent for hCG, and a detection zone;

b) a second assay flow-path, comprising a mobilizable labeled binding reagent for hCG and a second binding reagent for hCG, wherein the second binding reagent for hCG alters the sensitivity of an assay for hCG, and a detection zone, such that the first assay flow-path detection zone is for measuring hCG in a lower concentration range and the second assay flow-path detection zone is for measuring hCG in a higher concentration range;

c) a processor;

d) a first stored analyte threshold corresponding to a first time since conception, a second stored analyte threshold corresponding to a second time since conception, which is a longer period of time than that corresponding to the first stored analyte threshold, and a third stored analyte threshold which is a minimum pregnancy threshold, said analyte thresholds being stored in said electronic pregnancy test device and accessible to the processor;

e) a shared reference zone, the shared reference zone being located within the first or second assay flow-path, the other of the first or second assay flow path having no reference zone located therein, wherein the value of a signal obtained at the shared reference zone compensates the value of a signal obtained at the detection zone of the other of the first or second assay flow-path;

f) a measurement means for measuring a first analyte signal value from said first assay flow-path, and for measuring a second analyte signal value from said second assay flow-path, said first and second analyte signal values corresponding to the level of hCG in a liquid sample obtained from said subject, and comparing said first and/or second analyte signal values to the first, second, or third stored analyte thresholds, wherein a second analyte signal value greater than the second stored threshold indicates the subject is 3+ weeks pregnant;

a second analyte signal value less than said second stored threshold but a first analyte signal value greater than the first stored threshold indicates the subject is 2-3 weeks pregnant;

a first analyte signal value less than the first stored threshold but greater than the third stored threshold indicates the subject is 1-2 weeks pregnant; and

a first analyte signal value less than the third stored threshold indicates that the subject is not pregnant; and

g) a display means to display a result of the assay which is the quantitative estimate of the length of time since conception.

2. The test device according to claim 1, which further comprises one or more additional stored analyte thresholds corresponding to one or more times since conception.

3. The test device according to claim 1, wherein the first assay flow-path and the second assay flow-path each comprise a single detection zone.

4. The test device according to claim 1, further comprising a shared control zone located within the first or second assay flow-path, the other of the first or second assay flow-path having no control zone located therein, wherein measurement of a signal at the shared control zone provides a value or indication that the assay has been carried out correctly.

5. The test device according to claim 1, wherein the measurement means comprises a single photodetector to detect light from both detection zones, and four light sources to illuminate respectively the shared reference zone, a shared control zone and the two detection zones.

6. The test device according to claim 1, wherein the shared reference zone is provided downstream of the detection zone for the first or second assay flow-path.

7. The test device according to claim 1, wherein one or both assay flow-paths comprises a lateral flow porous carrier.

8. The test device according to claim 7, wherein the lateral flow porous carrier comprises nitrocellulose.

9. The device of claim 1, wherein the second analyte signal value is diminished compared to the first analyte signal value due to the presence of the second binding reagent for hCG, which diminishes the amount of hCG available to be bound at the detection zone relative to the first assay flow-path.

10. The device of claim 1, wherein the first assay flow-path or the second assay flow-path comprises a control zone downstream of their respective detection zones.

11. The device of claim 10, wherein the control zone is a shared control zone.

12. The device of claim 10, wherein a signal value determined at the control zone is used to validate the result of the first and second assay flow-paths respectively.

13. The device of claim 1, wherein the reference zone is downstream of the detection zone within the first or second assay flow-path.

14. An electronic pregnancy test device for calculating a quantitative estimate of the length of time since conception in a female mammalian subject, the device comprising:

a) a first assay flow-path, comprising a mobilizable labeled binding reagent for hCG, and a detection zone;

b) a second assay flow-path, comprising a mobilizable labeled binding reagent for hCG and a second binding reagent for hCG, wherein the second binding reagent for hCG alters the sensitivity of an assay for hCG, and a detection zone, such that the first assay flow-path detection zone is for measuring hCG in a lower concentration range and the second assay flow-path detection zone is for measuring hCG in a higher concentration range;

c) a processor;

d) a first stored analyte threshold corresponding to a first time since conception, a second stored analyte threshold corresponding to a second time since conception, which is a longer period of time than the first stored analyte threshold, and a third stored analyte threshold which is a minimum pregnancy threshold, said analyte thresholds being stored in said electronic pregnancy test device and accessible to the processor;

e) a shared reference zone, the shared reference zone being located within a subsidiary flow-path to the first and second assay flow-paths, the first and second assay flow-paths having no reference zone located therein, wherein the value of a signal obtained at the shared reference zone compensates the value of signals obtained at the detection zones of the first and second assay flow-paths;

f) a measurement means for measuring a first analyte signal value from said first assay flow-path, and for measuring a second analyte signal value from said second assay flow-path, said first and second analyte signal values corresponding to the level of hCG in a liquid sample obtained from said subject, and comparing said first and/or second analyte signal values to the first, second, or third stored analyte thresholds, wherein a second analyte signal value greater than the second stored threshold indicates the subject is 3+ weeks pregnant;

a second analyte signal value less than said second stored threshold but a first analyte signal value greater than the first stored threshold indicates the subject is 2-3 weeks pregnant;

a first analyte signal value less than the first stored threshold but greater than the third stored threshold indicates the subject is 1-2 weeks pregnant; and

a first analyte signal value less than the third stored threshold indicates that the subject is not pregnant; and

g) a display means to display a result of the assay which is the quantitative estimate of the length of time since conception.

15. The test device according to claim 14, which further comprises one or more additional stored analyte thresholds corresponding to one or more times since conception.

16. The test device according to claim 14, wherein the first assay flow-path and the second assay flow-path each comprise a single detection zone.

17. The test device according to claim 14, further comprising a shared control zone located within the first or second assay flow-path, the other of the first or second assay flow-path having no control zone located therein, wherein measurement of a signal at the shared control zone provides a value or indication that the assay has been carried out correctly.

18. The test device according to claim 14, wherein the measurement means comprises a single photodetector to detect light from both detection zones, and four light sources to illuminate respectively the shared reference zone, a shared control zone and the two detection zones.

19. The test device according to claim 14, wherein the shared reference zone is provided downstream of the detection zone for the first or second assay flow-path.

20. The test device according to claim 14, wherein one or both assay flow-paths comprises a lateral flow porous carrier.

21. The test device according to claim 20, wherein the lateral flow porous carrier comprises nitrocellulose.

22. The test device according to claim 14, wherein the second analyte signal value is diminished compared to the first analyte signal value due to the presence of the second binding reagent for hCG, which diminishes the amount of hCG available to be bound at the detection zone relative to the first assay flow-path.

23. The test device according to claim 14, wherein the first assay flow-path or the second assay flow-path comprises a control zone downstream of their respective detection zones.

24. The test device according to claim 23, wherein the control zone is a shared control zone.

25. The test device according to claim 23, wherein a signal value determined at the control zone is used to validate the result of the first and second assay flow-paths respectively.

26. The test device according to claim 14, wherein the reference zone within the first or second assay flow-path is downstream of the detection zone.