IP Library Granted Patent US 11,726,085
Granted Patent B2
US 11,726,085 · App. 17/549,725 · Granted Aug 15, 2023

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 11,726,085
App. No.
17/549,725
Granted
Aug 15, 2023
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 (SEQ ID NO: 1) or an analog thereof; ELAGLGFAELQC (SEQ ID NO: 4) or an analog thereof; and CDWRKNIDAL (SEQ ID NO: 8) or an analog thereof; specific binding reagents that bind to a CPRRPYIL (SEQ ID NO: 1), ELAGLGFAELQC (SEQ ID NO: 4) or CDWRKNIDAL (SEQ ID NO: 8) 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 (26)

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 either one of the dried reagent zone or the control zone comprises a peptide consisting of at least 87.5% homology to SEQ ID NO: 4.

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 2 , wherein the peptide consists of SEQ ID No: 4.

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

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

8. The device of claim 6 , wherein the peptide consists of SEQ ID NO: 4.

9. 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 either one of the dried reagent zone or the control zone comprises a peptide consisting of at least 87.5% homology to SEQ ID NO: 8.

10. The device of claim 9 , wherein the control zone comprises the peptide.

11. The device of claim 9 , wherein the peptide is immobilized in the control zone.

12. The device of claim 11 , wherein the dried reagent zone comprises an agent conjugated to a detectable label.

13. The device of claim 10 , wherein the peptide consists of SEQ ID No: 8.

14. The device of claim 9 , wherein the dried reagent zone comprises the peptide.

15. The device of claim 14 , wherein the peptide is conjugated to a detectable label.

16. The device of claim 14 , wherein the peptide consists of SEQ ID NO: 8 .

Assignments (7)
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 Dec 16, 2021
From: GARY, JONATHAN; RONGEY, SCOTT; POWELL, JAMES
To: ALERE SAN DIEGO, INC.
Reel/Frame 058525/0662 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2021
From: GARY, JONATHAN; RONGEY, SCOTT; POWELL, JAMES
To: ALERE SAN DIEGO, INC.
Reel/Frame 058525/0794 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2021
From: ALERE SAN DIEGO, INC.
To: QUIDEL CARDIOVASCULAR INC.
Reel/Frame 058525/0804 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 16, 2021
From: GARY, JONATHAN; RONGEY, SCOTT; POWELL, JAMES
To: QUIDEL CARDIOVASCULAR INC.
Reel/Frame 058525/0834 →