Soluble immunoreactive treponema pallidum TpN47 antigens
AssigneeRoche Diagnostics Operations, Inc.
InventorsElke Faatz, Peter Schaarschmidt, Urban Schmitt, Christian Scholz
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Abstract
The invention concerns soluble variants of Treponema pallidum antigen 47 (TpN47 antigen) comprising at least domain B, or at least domains A and B, optionally domain D of the complete TpN47 protein molecule with the proviso that all antigens lack domain C (amino acid residues 224 to 351) of TpN47. The Tpn47 antigens can be fused to a chaperone. Moreover, the invention covers DNA encoding the antigens, a method of producing these antigens as well as the use of these antigens in an immunodiagnostic assay for the detection of antibodies against Treponema pallidum in an isolated sample.
Claims15
A fusion protein comprising a soluble Treponema pallidum antigen 47 (TpN47 antigen), the TpN47 antigen comprising amino acid residues 418 to 529 (domain B) and lacking amino acid residues 579 to 706 (domain C) of SEQ ID NO. 1, and a chaperone.
A fusion protein comprising a soluble Treponema pallidum antigen 47 (TpN47 antigen), the TpN47 antigen comprising amino acid residues 381 to 578 (domains A+B) and lacking amino acid residues 579 to 706 (domain C) of SEQ ID NO. 1, and a chaperone.
A composition comprising at least two soluble Treponema pallidum antigen 47 (TpN47 antigen) antigens, the at least two soluble TpN47 antigens independently selected from the group consisting of a TpN47 antigen comprising amino acid residues 418 to 529 (domain B) and lacking amino acid residues 579 to 706 (domain C) of SEQ ID NO. 1 and a TpN47 antigen comprising amino acid residues 381 to 578 (domains A+B) and lacking amino acid residues 579 to 706 (domain C) of SEQ ID NO. 1, and at least one Treponema pallidum antigen selected from the group consisting of a Treponema pallidum antigen 17 (TpN17 antigen) and a Treponema pallidum antigen 15 (TpN15 antigen).
A method for detecting antibodies specific for Treponema pallidum in an isolated sample said method comprising:
- a) forming an immunoreaction admixture by admixing a body fluid sample with at least one Treponema pallidum antigen 47 (TpN47 antigen) selected from the group consisting of a TpN47 antigen comprising amino acid residues 418 to 529 (domain B) and lacking amino acid residues 579 to 706 (domain C) of SEQ ID NO. 1 and a TpN47 antigen variant comprising amino acid residues 381 to 578 (domains A+B) and lacking amino acid residues 579 to 706 (domain C) of SEQ ID NO. 1;
- b) maintaining said immunoreaction admixture for a time period sufficient for allowing antibodies that specifically bind to said TpN47 antigen present in the body fluid sample to immunoreact with said TpN47 antigen to form an immunoreaction product;
- and
- c) detecting the presence and/or the concentration of any of said immunoreaction product.
A reagent kit for detecting anti-Treponema pallidum antibodies, comprising at least one Treponema pallidum antigen 47 (TpN47 antigen) selected from the group consisting of a TpN47 antigen comprising amino acid residues 418 to 529 (domain B) and lacking amino acid residues 579 to 706 (domain C) of SEQ ID NO. 1 and a TpN47 antigen comprising amino acid residues 381 to 578 (domains A+B) and lacking amino acid residues 579 to 706 (domain C) of SEQ ID NO. 1.
Dependencies are inferred from the claim text.