Method for reducing analyzer variability using a normalization target

• US 9,989,466 B2
• Filed: 12/05/2014
• Issued: 06/05/2018
• 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:
  US14/562,060
• Publication Number:
  US 20150160134A1
• Time in Patent Office: 1,278 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 optical instrument previously calibrated with an external calibrant and having stored in instrument memory a calibration value, comprising:

providing the 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 the calibration value, the assigned normalization value stored in instrument memory;

inserting an external calibrant into the instrument;

collecting light emission data from the external calibrant and from the embedded normalization target in a single scan or image;

assigning an updated normalization value to the embedded normalization target;

scanning or imaging in a single scan;

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

(ii) the embedded 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.

2. The method of claim 1, wherein, if the assigned normalization value exceeds a predefined value or differs from the current normalization value by more than about 2%, the instrument issues a communication to the user.

3. The method of claim 2, wherein the communication advises that an updated normalization value should be assigned to the embedded normalization target.

4. The method of claim 1, wherein the scaling factor used to adjust the test signal is a ratio of the current normalization value to the assigned normalization value.

5. The method of claim 1, wherein the embedded normalization target and the external calibrant are constructed from the same material.

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

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

8. The method of claim 1, wherein the optical instrument comprises an optics module for detecting at least one of emitted fluorescent light or emitted reflected light.

9. The method of claim 1, wherein the optical instrument comprises a digital camera to collect light output data from a test device and normalization target.

10. A method to improve precision of a test signal from an optical instrument previously calibrated with an external calibrant and having stored in instrument memory a calibration value, comprising:

providing the 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 the calibration value, the assigned normalization 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 embedded 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.

11. The method of claim 10, wherein if the normalization value exceeds a predefined value, a communication to a user is generated by the instrument.

12. The method of claim 11, wherein the communication advises that the instrument requires re-normalization with the embedded normalization target.

13. The method of claim 11, wherein the communication advises that an updated normalization value should be assigned to the embedded normalization target.

14. The method of claim 10, wherein collecting light emission data comprises optically interrogating with an excitation wavelength between about 300-800 nm.

15. The method of claim 10, wherein the instrument does not adjust the test signal by the scaling factor.

16. The method of claim 10, wherein the embedded normalization target is affixed in an optical pathway in the instrument.

17. The method of claim 10, wherein the embedded normalization target is affixed to an element in the instrument that is capable of receiving a test strip.

18. The method of claim 10, wherein the optical instrument comprises an optics module for detecting at least one of emitted fluorescent light or emitted reflected light.

19. The method of claim 10, wherein the instrument comprises a digital camera to collect light output data from a test device and normalization target.