Method for reducing analyzer variability using a normalization target

• US 10,495,574 B2
• Filed: 05/09/2018
• Issued: 12/03/2019
• Est. Priority Date: 12/06/2013
• Status: Active Grant

• Current Assignee: Quidel Corporation
• Original Assignee: Quidel Corporation
• Inventors: Booker, David Dickson, Steadman, Jhobe
• Primary Examiner(s): Lee, Cheung
• Application Number:
  US15/975,686
• Publication Number:
  US 20180259453A1
• Time in Patent Office: 573 Days
• CPC Class Codes: G01N 21/274 Calibration, base line adjustment, drift correction
• CPC Class Codes: G01N 21/278 Constitution of standards
• CPC Class Codes: G01N 21/645 Specially adapted constructive features of fluorimeters
• CPC Class Codes: G01N 2201/068 Optics, miscellaneous
• CPC Class Codes: G01N 2201/10 Scanning
• CPC Class Codes: G01N 2201/12746 Calibration values determination
• CPC Class Codes: G01N 2201/12753 and storage
• CPC Class Codes: G01N 2201/12761 Precalibration, e.g. for a given series of reagents

Abstract

Disclosed herein is a method for improving the precision of a test result from an instrument with an optical system that detects a signal. The method comprises including in the instrument a normalization target disposed directly or indirectly in the optical path of the optical system. Also disclosed are instruments comprising a normalization target, and systems comprising such an instrument and a test device that receives a sample suspected of containing an analyte.

Claims

1. A method to improve precision of a test result from an instrument, comprising:

providing an optical instrument comprising a normalization target embedded in or on the instrument, the normalization target having an assigned normalization value based on its detected signal relative to detected signal associated with a calibration value stored in instrument memory;

scanning or imaging in a single scan;

(i) a test cartridge inserted into the instrument to obtain a test signal, and

(ii) the normalization target to obtain a current normalization value;

optionally adjusting the test signal by a scaling factor based on the current normalization value; and

obtaining a scaled test result with improved precision relative to the test signal.

2. The method of claim 1, wherein the normalization target is affixed in an optical pathway in the instrument.

3. The method of claim 2, wherein the normalization target is affixed to an element in the instrument that is capable of receiving a test strip.

4. The method of claim 1, wherein the normalization target is affixed to an element in the instrument that is capable of receiving a test strip.

5. The method of claim 1, wherein the scanning or imaging in a single scan comprises scanning by an optics module that detects emitted fluorescent light or emitted reflected light.

6. The method of claim 1, wherein the scanning or imaging in a single scan comprises imaging using a digital camera.

7. The method of claim 1, wherein the normalization target is comprised of a rhodamine.

8. The method of claim 7, wherein the rhodamine is selected from the group consisting of rhodamine B, rhodamine 6G and sulphorhodamine G.

9. A method to improve precision of a test result from an instrument, comprising:

providing an optical instrument comprising a normalization target embedded in or on the instrument, the normalization target comprised of a rhodamine and having an assigned normalization value based on its detected signal relative to detected signal associated with a calibration value stored in instrument memory;

scanning or imaging in a single scan;

(i) a test cartridge inserted into the instrument to obtain a test signal; and

(ii) the normalization target to obtain a current normalization value; and

optionally adjusting the test signal by a scaling factor based on the current normalization value, thereby obtaining a scaled test result with improved precision relative to test signal.

10. The method of claim 9, wherein the normalization target is affixed in an optical field in the instrument.

11. The method of claim 9, wherein the normalization target is affixed to an element in the instrument that is capable of receiving a test strip.

12. The method of claim 9, wherein the scanning or imaging in a single scan comprises scanning by a movable optics module that detects emitted fluorescent light or emitted reflected light.

13. The method of claim 9, wherein the scanning or imaging in a single scan comprises imaging using a digital camera.

14. The method of claim 9, wherein the rhodamine is selected from the group consisting of rhodamine B, rhodamine 6G and sulphorhodamine G.