Treponema pallidum triplet antigen

Patent metadata

Field	Value
Publication number	US-10125177-B2
Application number	US-201815865594-A
Country	US
Kind code	B2
Filing date	Jan 9, 2018
Priority date	Jan 13, 2011
Publication date	Nov 13, 2018
Grant date	Nov 13, 2018

Abstract

A Treponema pallidum triplet antigen construct is disclosed which includes three Treponema pallidum antigens (TP15, TP17, and TP47), as well as a ten amino acid leader sequence (tag 261) and human copper zinc superoxide dismutase (hSOD). This construct is optimized for in vitro diagnosis of syphilis infection. Plasmids containing DNA encoding the triplet antigen, host cells, production methods, detection methods, and kits are also disclosed.

First claim

The invention claimed is:

1. A Treponema pallidum triplet antigen comprising the amino acid sequence as shown in SEQ ID NO:10.

2. The Treponema pallidum triplet antigen of claim 1 labeled with a detectable marker.

3. The Treponema pallidum triplet antigen of claim 2 wherein the detectable marker is horseradish peroxidase.

4. A kit for detection of Treponema pallidum antibodies, the kit comprising:
the Treponema pallidum triplet antigen of claim 1 ; and
a second Treponema pallidum triplet antigen of claim 1 , the second Treponema pallidum triplet antigen labeled with a detectable marker.

5. The kit of claim 4 further comprising positive or negative controls.

6. The kit of claim 4 further comprising calibration samples.

7. The kit of claim 4 further comprising one or more of enzyme conjugate, substrate for enzyme conjugate, buffer solution, and washing solution.

8. A method of detecting the presence of Treponema pallidum antibodies in a sample, the method comprising:
contacting the sample with a first antigen which is immobilized on a solid support and which comprises the Treponema pallidum triplet antigen of claim 1 , wherein Treponema pallidum antibodies present in the sample bind to the Treponema pallidum triplet antigen forming an antibody/antigen complex; and
detecting the antibody/antigen complex, thereby detecting the presence of Treponema pallidum antibodies.

Assignees

• Ortho Clinical Diagnostics Inc

Inventors

• Zheng Jian
• Yura Renee
• Yang Jianping

Classifications

• G01N33/571

  for venereal disease, e.g. syphilis, gonorrhoea {(herpes G01N33/56994; chlamydia G01N33/56927)} · CPC title

• C07K2319/40

  containing a tag for immunodetection, or an epitope for immunisation · CPC title

• G01N33/56911

  Bacteria · CPC title

• C07K2319/00

  Fusion polypeptide · CPC title

• G01N2333/20

  from Spirochaetales (O), e.g. Treponema, Leptospira · CPC title