IP Library › Granted Patent US 12,123,875
Granted Patent B2
US 12,123,875 · App. 17/840,557 · Granted Oct 22, 2024

Antigen analogue for calibration of immunometric diagnostic assays

Inventors: Brett Hirsch (Raritan, NJ); Jian Zheng (Raritan, NJ); Stephen Daggett (Raritan, NJ)
Assignee: Ortho Clinical Diagnostics, Inc.
G01N33/566C07K7/08G01N2333/165G01N2333/58G01N2333/635
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Quick Facts
Patent No.
US 12,123,875
App. No.
17/840,557
Granted
Oct 22, 2024
Kind
B2
Abstract

An antigen with an increased half-life is provided for the formulation of more stable and consistent clinical diagnostic immunoassay controls and calibrators. An antigen analogue comprises a first and a second polypeptide which is identical or similar to corresponding terminal amino acid sequences of an antigen. The first and second polypeptides are connected with a PEG chain. Also provided are methods of calibrating assays using a compound disclosed herein.

Claims (15)

1. A compound of formula (I):

X—O—(CH 2 CH 2 O) n —Y  (I)

wherein

(i) X is RVEWLRKKLQDVHN (SEQ ID NO:1) and Y is EDNVLVESH (SEQ ID NO:2),

(ii) X is DLETSGLQEQRN (SEQ ID NO:3) and Y is PLQESPRPT (SEQ ID NO:4), or

(iii) X is GYYRRATRRIRGGDGKMKDLS (SEQ ID NO:5) and Y is QRQKKQQTVTLLPAADLDDFS (SEQ ID NO:6), and

n is an integer between 1 and 30.

2. The compound of claim 1 , wherein X is RVEWLRKKLQDVHN (SEQ ID NO:1) and Y is EDNVLVESH (SEQ ID NO:2).

3. The compound of claim 1 , wherein X is DLETSGLQEQRN (SEQ ID NO:3) and Y is PLQESPRPT (SEQ ID NO:4).

4. The compound of claim 1 , wherein X is GYYRRATRRIRGGDGKMKDLS (SEQ ID NO:5) and Y is QRQKKQQTVTLLPAADLDDFS (SEQ ID NO:6).

5. The compound of claim 1 , wherein n is an integer between 1 and 8.

6. A method of calibrating an immunometric diagnostic assay comprising measuring the intensity of light signals using the compound of claim 1 .

7. The method of claim 6 , wherein the assay is an intact parathyroid hormone (iPTH) immunometric diagnostic assay wherein X is RVEWLRKKLQDVHN (SEQ ID NO:1) and Y is EDNVLVESH (SEQ ID NO:2).

8. The method of claim 6 , wherein the assay is an N-terminal pro b-type natriuretic peptide (NTproBNP) immunometric diagnostic assay, wherein X is DLETSGLQEQRN (SEQ ID NO:3) and Y is PLQESPRPT (SEQ ID NO:4).

9. The method of claim 6 , wherein the assay is a severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunometric diagnostic assay, wherein X is GYYRRATRRIRGGDGKMKDLS (SEQ ID NO:5) and Y is QRQKKQQTVTLLPAADLDDF (SEQ ID NO:6).

Assignments (2)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 28, 2022
From: HIRSCH, BRETT; ZHENG, JIAN; DAGGETT, STEPHEN
To: ORTHO-CLINICAL DIAGNOSTICS, INC.
Reel/Frame 060655/0121 →