Patent ID: 7771928

Claim:
An immunoassay device for detecting an anti-syphilis treponeme antibody in a specimen which comprises a matrix which can transfer a solution by capillarity, wherein the following are disposed on the matrix: (1) a specimen dotting zone, (2) a labeling reagent zone comprising a labeled genetic recombinant syphilis treponeme antigen, wherein the labeling reagent zone is downstream of the specimen dotting zone or the specimen dotting zone is provided on the labeling reagent zone, and the genetic recombinant syphilis treponeme antigen is at least one selected from the group consisting of a TP 15 antigen having a molecular weight of 15 kpa, a TP17 antigen having a molecular weight of 17 kDa, a TP42 antigen having a molecular weight of 42 kDa and a TP47 antigen having a molecular weight of 47 kDa and a fusion antigen of syphilis treponema in which two or more above syphilis treponeme antigens are fused, (3) at least two detection zones each comprising an immobilized genetic recombinant syphilis treponeme antigen which binds a complex formed between the anti-syphilis treponeme antibody and the labeled genetic recombinant syphilis treponeme antigen, wherein the detection zones are downstream of the labeling reagent zone and in one of the at least two detection zones, the genetic recombinant syphilis treponeme antigen is a TP47 antigen having a molecular weight of 47 kDa, and in the other of the at least two detection zones, the genetic recombinant syphilis treponeme antigen is at least one selected from the group consisting of a TP 15 antigen having a molecular weight of 15 kDa, a TP17 antigen having a molecular weight of 17 kDa, a TP42 antigen having a molecular weight of 42 kDa and a fusion antigen of syphilis treponema in which two or more above syphilis treponeme antigens are fused.