ASSAY TEST STRIPS AND READING SAME

• US 20090180927A1
• Filed: 03/24/2009
• Published: 07/16/2009
• Est. Priority Date: 04/22/2005
• Status: Abandoned Application

• Current Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Original Assignee: Alverix, Inc. (Becton, Dickinson & Co)
• Inventors: Zhou, Rong, Brosnan, Michael J., Roitman, Daniel B., Petruno, Patrick T., Petrilla, John F., Curry, Bo U.
• Application Number:
  US12/409,877
• Publication Number:
  US 20090180927A1
• Time in Patent Office: Days
• US Class Current: 422/56
• CPC Class Codes: G01N 2021/6439 with indicators, stains, dyes, tags, labels, marks
• CPC Class Codes: G01N 21/17 Systems in which incident light is modified in accordance with the properties of the material investigated where the material investigated is optically excited causing a change in wavelength of the incident light G01N21/63
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/6428 Measuring fluorescence of fluorescent products of reactions or of fluorochrome labelled reactive substances, e.g. measuring quenching effects, using measuring "optrodes" in vivo A61B5/00; immunoassay G01N33/53
• 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 2201/062 LED's
• CPC Class Codes: G01N 2201/067 Electro-optic, magneto-optic, acousto-optic elements
• CPC Class Codes: G01N 33/54388 based on lateral flow
• CPC Class Codes: G01N 33/54393 Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding
• CPC Class Codes: G01N 33/558 using diffusion or migration of antigen or antibody immunochromatographic test strips G01N33/54387
• CPC Class Codes: G01N 33/58 involving labelled substances G01N33/53 takes precedence
• CPC Class Codes: Y10S 435/805 Test papers
• CPC Class Codes: Y10S 435/823 Acetobacter
• CPC Class Codes: Y10S 436/807 Apparatus included in process claim, e.g. physical support structures
• CPC Class Codes: Y10S 436/809 Multifield plates or multicontainer arrays
• CPC Class Codes: Y10S 436/81 Tube, bottle, or dipstick
• CPC Class Codes: Y10S 436/823 Immunogenic carrier or carrier per se
• CPC Class Codes: Y10T 436/25125 Digestion or removing interfering materials

Abstract

An assay test strip includes a flow path, a sample receiving zone, a label, a detection zone that includes a region of interest, and at least one position marker. The at least one position marker is aligned with respect to the region of interest such that location of the at least one position marker indicates a position of the region of interest. A diagnostic test system includes a reader that obtains light intensity measurement from exposed regions of the test strip, and a data analyzer that performs at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

Claims

1-30. -30. (canceled)

31. A diagnostic test system, comprising:

a housing comprising a port constructed and arranged to receive a test strip that comprises a flow path for a fluid sample, a sample receiving zone coupled to the flow path, a label that specifically binds a target analyte, a detection zone coupled to the flow path and comprising a test region exposed for optical inspection and having an immobilized test reagent that specifically binds the target analyte, and at least one reference feature;

a reader operable to obtain light intensity measurements from exposed regions of the test strip when the test strip is loaded in the port; and

a data analyzer operable to perform operations comprising at least one of (a) identifying ones of the light intensity measurements obtained from the test region based on at least one measurement obtained from the at least one reference feature, and (b) generating a control signal modifying at least one operational parameter of the reader based on at least one measurement obtained from the at least one reference feature.

32. The system of claim 31, wherein the reference feature is aligned with respect to the test region, and the data analyzer is operable to determine ones of the light intensity measurements obtained from the at least one reference feature.

33. The system of claim 32, wherein the data analyzer is operable to identify the ones of the light intensity measurements obtained from the test region based on a rule correlating imaged positions of the determined ones of the light intensity measurements obtained from the at least one reference feature and light intensity measurements obtained from the test region.

34. The system of claim 31, wherein the reference feature comprises an encoding of position in the detection zone formed by a spatial arrangement of the immobilized test reagent in the test region.

35. The system of claim 31, further comprising a detection system operable to detect the reference feature, and wherein the data analyzer is operable to identify ones of the light intensity measurements obtained from the test region by correlating detection of the reference feature by the detection system with the obtaining of the light intensity measurements by the reader.

36. The system of claim 35, wherein the reference feature comprises an electrical conductor on a surface of the test strip.

37. The system of claim 35, wherein the reference feature comprises a mechanical feature having a different surface profile on the test strip than adjacent areas of the test strip.

38. The system of claim 37, further comprising a mechanical transducer configured to generate signals indicative of surface profile variations across the test strip.

39. The system of claim 31, wherein the at least one reference feature produces a series of contrast variations along the flow path, the reader is operable to obtain from the at least one reference feature a series of light intensity measurements encoding positions along the flow path, and the data analyzer is operable to decode the series of light intensity measurements into positions along the flow path and identify the ones of the light intensity measurements obtained

from the test region based on the positions decoded from the series of light intensity measurements.

40. The system of claim 31, wherein the reference feature is adjacent to the test region, and the data analyzer is operable to identify the ones of the light intensity measurements obtained from the test region based on light intensity measurements obtained from the reference feature.

41. The system of claim 31, wherein the reference feature is calibrated to provide at least one reference optical response to illumination with a specified wavelength range, and the data analyzer is operable to determine an amount of the analyte captured in the test region based on the at least one light intensity measurement obtained from the reference feature and at least one light intensity measurement obtained from the test region.

42. The system of claim 31, wherein:

the at least one reference feature comprises a first reference feature over the flow path upstream of and adjacent to the test region, and a second reference feature over the flow path downstream of and adjacent to the test region; and

the data analyzer is operable to determine a measurement calibration value from light intensity measurements obtained from the first and second reference features and to determine an amount of the analyte based on the light intensity measurements obtained from the test region and the determined measurement calibration value.

43. The system of claim 31, wherein the at least one reference feature comprises an illumination source calibration region, the reader comprises an illumination source operable to illuminate the test strip when the test strip is loaded in the port, and the data analyzer is operable to generate a signal for calibrating the illumination source based on the at least one light intensity measurement obtained from the illumination source calibration region.

44-55. -55. (canceled)