IP Library Granted Patent US 11,237,163
Granted Patent B2
US 11,237,163 · App. 16/083,486 · Granted Feb 1, 2022

Immunoassay controls and the use thereof

Inventors: Jonathan Gary (San Diego, CA); Scott Rongey (San Diego, CA); James Powell (San Diego, CA)
Assignee: Quidel Cardiovascular Inc.
G01N33/558C07K16/18G01N33/54393G16H40/63G01N33/6887G01N33/74G01N2333/4712G01N2410/00
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Quick Facts
Patent No.
US 11,237,163
App. No.
16/083,486
Granted
Feb 1, 2022
Kind
B2
Abstract

The present invention relates to compositions and methods use in designing immunoassay controls. In various aspects, the invention provides synthetic peptides comprising the sequence CPRRPYIL or an analog thereof; ELAGLGFAELQC or an analog thereof; and CDWRKNIDAL or an analog thereof; specific binding reagents that bind to a CPRRPYIL, ELAGLGFAELQC or CDWRKNIDAL peptide; methods of producing such reagents; and assays utilizing such reagents to provide assay controls signals that are unrelated to the measurement of the analyte or analytes of interest in that no reagents used in the analyte assay(s) contribute to the control signal.

Claims (19)

1. A device, comprising:

a substrate defining at least one diagnostic lane;

a sample application zone;

a dried reagent zone; and

a detection zone comprising at least one control zone and at least one assay zone;

wherein at least one of the dried reagent zone or the control zone comprises a peptide having 87.5% identify to SEQ ID No: 1.

2. The device of claim 1 , wherein the control zone comprises the peptide.

3. The device of claim 2 , wherein the peptide is immobilized in the control zone.

4. The device of claim 3 , wherein the dried reagent zone comprises an agent conjugated to a detectable label.

5. The device of claim 1 , wherein the dried reagent zone comprises the peptide.

6. The device of claim 5 , wherein the peptide is conjugated to a detectable label.

7. A device, comprising:

a substrate defining at least one diagnostic lane;

a sample application zone;

a dried reagent zone; and

a detection zone comprising at least one control zone and at least one assay zone;

wherein the at least one control zone comprises a peptide of SEQ ID NO: 1.

8. The device of claim 7 , wherein the peptide is immobilized in the control zone.

9. The device of claim 8 , wherein the dried reagent zone comprises an agent conjugated to a detectable label.

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 →
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 Feb 11, 2019
From: GARY, JONATHAN; RONGEY, SCOTT; POWELL, JAMES
To: QUIDEL CARDIOVASCULAR INC.
Reel/Frame 048299/0311 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 7, 2018
From: ALERE SAN DIEGO, INC.
To: QUIDEL CARDIOVASCULAR INC.
Reel/Frame 046821/0611 →