Pretreatment method for rapid detection of HCV core antigen

Patent metadata

Field	Value
Publication number	US-11327077-B2
Application number	US-201816204681-A
Country	US
Kind code	B2
Filing date	Nov 29, 2018
Priority date	May 31, 2016
Publication date	May 10, 2022
Grant date	May 10, 2022

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.

First claim

The invention claimed is:

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.

Assignees

• Roche Diagnostics Operations Inc

Inventors

• Upmeier Barbara
• Zarnt Toralf
• Ginter Manfred
• Bollhagen Ralf

Classifications

• G01N33/5767 Primary

  non-A, non-B hepatitis · CPC title

• G01N33/84

  involving inorganic compounds or pH · CPC title