Test strips and method for reading test strips

• US 9,063,091 B2
• Filed: 03/13/2013
• Issued: 06/23/2015
• Est. Priority Date: 04/06/2012
• Status: Active Grant

• Current Assignee: iXensor Co., Ltd
• Original Assignee: iXensor Inc.
• Inventors: Chen, Yenyu, Tsai, Tungmeng, Chen, Chieh Hsiao
• Primary Examiner(s): Mui, Christine T
• Application Number:
  US13/798,175
• Publication Number:
  US 20130267032A1
• Time in Patent Office: 832 Days
• Field of Search: 436/95, 436/94, 436/93, 436/91, 436/164, 422/400, 422/50
• US Class Current: 1/1
• CPC Class Codes: G01N 2021/8488 the band presenting reference patches
• CPC Class Codes: G01N 21/78 producing a change of colour
• 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 33/48771 Coding of information, e.g. calibration data, lot number
• CPC Class Codes: G01N 33/5094 for blood cell populations red blood cells G01N33/80
• CPC Class Codes: G01N 33/52 Use of compounds or compositions for colorimetric, spectrophotometric or fluorometric investigation, e.g. use of reagent paper and including single- and multilayer analytical elements immunological elements G01N33/54386; involving labelled immunochemicals G01N33/58; for haemoglobin or occult blood G01N33/72
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose
• CPC Class Codes: G06F 18/22 Matching criteria, e.g. proximity measures
• CPC Class Codes: G06T 7/0012 Biomedical image inspection
• CPC Class Codes: G06T 7/90 Determination of colour characteristics
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A specimen test strip is provided to detect a characteristic of an analyte in a specimen sample. The specimen test strip includes a reaction area to receive the specimen sample and a color calibration area to determine a color, or a color and a color intensity, of the reaction area after receiving the specimen sample. The specimen test strip may further include a temperature indication area to correct a measurement of the characteristic of analyte.

Claims

1. A specimen test strip to detect a characteristic of an analyte in a specimen sample, comprising:

a reaction area to receive the specimen sample and change color based on the characteristic of the analyte in the specimen sample;

a color calibration area comprising one or more samples with known color characteristics to be used to determine a color of the reaction area under different lighting conditions; and

a temperature calibration area to change color based on its temperature to be used to adjust a measurement of the characteristic of the analyte.

2. The specimen test strip of claim 1, wherein the color calibration area is to be used to determine a color intensity in addition to the color of the reaction area after receiving the specimen sample.

3. The specimen test strip of claim 1, wherein the temperature calibration area comprises a plurality of temperature calibration parts.

4. The specimen test strip of claim 1, wherein the color calibration area surrounds the reaction area.

5. The specimen test strip of claim 4, wherein the color calibration area comprises a ring-shaped area.

6. The specimen test strip of claim 1, wherein the color calibration area comprises a dummy reaction area that comprises an enzyme in the reaction area but is devoid of a dye in the reaction area.

7. The specimen test strip of claim 1, wherein the color calibration area comprises a dummy reaction area that comprises a dye in the reaction area but is devoid of an enzyme in the reaction area.

8. The specimen test strip of claim 1, wherein the color calibration area comprises a color chart having known color samples or a gray card having a known reflectance.

9. The specimen test strip of claim 1, further comprising a timer capillary to receive the specimen sample, the timer capillary being marked off with time durations.

10. The specimen test strip of claim 1, further comprising a timer area to receive the specimen sample and to change color linearly in response to the specimen sample.

11. The specimen test strip of claim 1, further comprising a timer area to change color in response to light or humidity.

12. The specimen test strip of claim 1, further comprising an other reaction area to receive the specimen sample.

13. The specimen test strip of claim 12 wherein the reaction area detects glucose level and the other reaction area detects a hematocrit level.

14. The specimen test strip of claim 1, further comprising:

a hole in a path of the specimen sample;

a top opening of the hole being covered by a first film, the first film being transparent; and

a bottom opening of the hole being covered by a second film.

15. The specimen test strip of claim 14, wherein the second film is more reflective than the first film.