IP Library Granted Patent US 10,845,300
Granted Patent B2
US 10,845,300 · App. 16/670,228 · Granted Nov 24, 2020

Method for reducing analyzer variability using a normalization target

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Quick Facts
Patent No.
US 10,845,300
App. No.
16/670,228
Granted
Nov 24, 2020
Kind
B2
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 (18)

1. A method to improve precision of a test result from an instrument, comprising: providing an 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 for detection of vitamin D, the test cartridge inserted into the instrument to obtain a test signal indicative of presence or absence of vitamin D; 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 the embedded normalization target is affixed in an optical pathway in the instrument.

3. The method of claim 2 , wherein the embedded 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 embedded 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 embedded 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 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, the test cartridge comprising reagents for detection of vitamin D; 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.

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

11. The method of claim 9 , wherein the embedded 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.

Assignments (5)
SECURITY AGREEMENT Recorded Aug 22, 2025
From: CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; QUIDEL CARDIOVASCULAR INC.
To: BANK OF AMERICA, N.A., AS ADMINISTRATIVE AGENT
Reel/Frame 072526/0643 →
RELEASE (REEL 060220 / FRAME 0711) Recorded Aug 22, 2025
From: BANK OF AMERICA, N.A.
To: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
Reel/Frame 072577/0536 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 15, 2024
From: QUIDEL CORPORATION
To: ORTHO-CLINICAL DIAGNOSTICS, INC.
Reel/Frame 068657/0827 →
SECURITY AGREEMENT Recorded May 31, 2022
From: QUIDEL CORPORATION; BIOHELIX CORPORATION; DIAGNOSTIC HYBRIDS, INC.; QUIDEL CARDIOVASCULAR INC.; ORTHO-CLINICAL DIAGNOSTICS, INC.; CRIMSON U.S. ASSETS LLC; CRIMSON INTERNATIONAL ASSETS LLC; MICRO TYPING SYSTEMS, INC.
To: BANK OF AMERICA, N.A.
Reel/Frame 060220/0711 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 31, 2019
From: BOOKER, DAVID DICKSON; STEADMAN, JHOBE
To: QUIDEL CORPORATION
Reel/Frame 050899/0393 →