Human factor XIII as a normalization control for immunoassays

Patent metadata

Field	Value
Publication number	US-9797902-B2
Application number	US-201715492905-A
Country	US
Kind code	B2
Filing date	Apr 20, 2017
Priority date	Jun 22, 2012
Publication date	Oct 24, 2017
Grant date	Oct 24, 2017

Abstract

The present disclosure provides compositions and methods that are useful for normalizing the amount of signal detected in an assay, such as an immunoassay. The compositions and methods are useful for improving the accuracy of immunoassays, such as immunoassays that detect whether a subject is infected with a retrovirus such as HIV.

First claim

What is claimed is:

1. A kit for determining whether a subject is infected with HIV or a stage of infection of a subject so infected, said kit comprising a normalization factor immobilized on a solid support, and a plurality of binding members, each binding member immobilized on a solid support, said plurality comprising:
(i) anti-p24 antibody,
(ii) HIV-1 envelope protein gp-160,
(ii) HIV-2 SPOH (RVTAIEKYLQDQARLNSWGCAFRQVC (SEQ ID NO:5)), and
(iv) HIV-O AFR (LNQQRLLNSWGCKGRLVCYTSV (SEQ ID NO:2));
said solid supports further bearing differentiation parameters selected such that all said supports bearing any one binding member of said plurality are differentiable from all said supports bearing other binding members of said plurality.

2. The kit of claim 1 , wherein the normalization factor does not bind an analyte from the biological sample.

3. The kit of claim 1 , wherein the normalization factor is hFXIII.

4. The kit of claim 1 , further comprising an antibody to human Factor XIII immobilized on a solid support.

5. The kit of claim 1 , further comprising tetramethylcadaverine rhodamine (TMRC) immobilized on a solid support.

6. The kit of claim 1 , wherein the solid supports are beads or magnetic beads.

Assignees

• Bio Rad Laboratories Inc

Inventors

• King David
• Link William F
• Del Rosario Renato
• Leos Michael

Classifications

• C12Y203/02013

  Protein-glutamine gamma-glutamyltransferase (2.3.2.13), i.e. transglutaminase or factor XIII · CPC title

• C12N9/1044

  Protein-glutamine gamma-glutamyltransferase (2.3.2.13), i.e. transglutaminase or factor XIII · CPC title

• G01N33/54393 Primary

  Improving reaction conditions or stability, e.g. by coating or irradiation of surface, by reduction of non-specific binding, by promotion of specific binding · CPC title

• C12N11/14

  Enzymes or microbial cells immobilised on or in an inorganic carrier · CPC title

• G01N33/56988 Primary

  HIV or HTLV · CPC title