IP Library › Granted Patent US 11,327,077
Granted Patent B2
US 11,327,077 · App. 16/204,681 · Granted May 10, 2022

Pretreatment method for rapid detection of HCV core antigen

Inventors: Barbara Upmeier (Iffeldorf, DE); Toralf Zarnt (Penzberg, DE); Manfred Ginter (Wielenbach, DE); Ralf Bollhagen (Penzberg, DE)
Assignee: Roche Diagnostics Operations, Inc.
G01N33/5767G01N33/84
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 11,327,077
App. No.
16/204,681
Granted
May 10, 2022
Kind
B2
Abstract

The present disclosure relates to a method for detecting a core polypeptide of a hepatitis C virus (HCV) in a sample from a subject with the steps of (a) contacting the sample with a surfactant comprising a cationic detergent; (b) contacting the sample with a binding compound; and (c) detecting a core polypeptide of the HCV in the sample; wherein step a) is immediately followed by step b). The present disclosure further relates to a method for pre-processing a sample from a subject for detection of an HCV core polypeptide, involving (a) contacting the sample with a surfactant comprising a cationic detergent and, optionally, with an agent inducing a pH shift, immediately followed by (b) contacting the sample with a binding compound. Moreover, the present disclosure further relates to uses, devices, and analytical systems related to aforesaid methods.

Claims (21)

1. A method for detecting a core polypeptide of a hepatitis C virus (HCV) in a sample from a subject comprising:

(a) contacting said sample with a surfactant comprising a cationic detergent;

(b) contacting said sample with a binding compound; and

(c) detecting a core polypeptide of said HCV in said sample;

wherein step (a) is immediately followed by step (b), wherein immediately is a time frame of from one second to less than five minutes, wherein the time frame between steps (a) and (b) starts with adding said surfactant to said sample, and ends with adding said binding compound, and

wherein step (a) further comprises contacting said sample with an agent inducing a pH shift of at least 2 pH units.

2. The method of claim 1 , wherein said sample is contacted with said agent inducing a pH shift and with said surfactant simultaneously.

3. The method of claim 1 , wherein immediately is a time frame of less than 5 min.

4. The method of claim 1 , wherein said cationic detergent is a quaternary ammonium detergent.

5. The method of claim 1 , wherein said cationic detergent is a hexadecyltrimethylammonium salt.

6. The method of claim 1 , wherein said surfactant further comprises a non-ionic detergent.

7. The method of claim 1 , wherein said surfactant further comprises an alkyl-glycoside.

8. The method of claim 1 , wherein said binding compound is a detector compound.

9. The method of claim 1 , wherein said binding compound is a detector antibody.

10. The method of claim 1 , wherein said detecting a core polypeptide comprises capturing said core polypeptide to a solid surface by means of a capture compound.

11. The method of claim 1 , wherein said detecting said core polypeptide comprises detecting said core polypeptide in a sandwich immunoassay.

12. The method of claim 1 , wherein said agent inducing a pH shift is a base.

13. The method of claim 1 , wherein said agent inducing a pH shift is an acid.

14. A method for pre-processing a sample form a subject for detection of an HCV core polypeptide, comprising (a) contacting said sample with a surfactant comprising a cationic detergent and with an agent inducing a pH shift of at least 2 pH units, immediately followed by (b) contacting said sample with a binding compound, wherein the time frame between steps (a) and (b) starts with adding said surfactant to said sample, and ends with adding said binding compound.

15. The method of claim 1 , further comprising contacting said sample with an alkali metal halogenide selected from the group consisting of potassium chloride (KCl) and sodium chloride (NaCl).

16. The method of claim 1 , wherein detecting a core polypeptide of said HCV in said sample is detected using an analytic system comprising an evaluation device, the evaluation device comprises a microprocessor and an output unit, said microprocessor programmed to receive output data from the output unit and operable to perform logical operations to provide an evaluation of said output data.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2018
From: BOLLHAGEN, RALF; UPMEIER, BARBARA; ZARNT, TORALF; GINTER, MANFRED
To: ROCHE DIAGNOSTICS GMBH
Reel/Frame 047734/0085 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 11, 2018
From: ROCHE DIAGNOSTICS GMBH
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 047734/0136 →
Priority Claims (1)
EP 16172155 · May 31, 2016 · regional
Continuity (2)
Continuation PCTEP2017063077 · May 31, 2017
Related Publication 20190086413A1 · Mar 21, 2019