title: [Evaluation of the Fundamental Performance of 4 Latex Agglutination Reagents to Measure Anti-TP Antibody Concentration and Detailed Investigation of Decision-Mismatched Samples].
abstract: Serological diagnosis of syphilis can be made by using the serological test for syphilis (STS) method for detecting a lipid antibody and Treponema pallidum (TP) method for detecting the anti-TP-specific antibody. In STS and TP methods, the basis using latex agglutination reaction has been used in many facilities. However, in latex agglutination, false-positive results due to non-specific reaction have sometimes been obtained in reactions of a routine laboratory test reagent detecting the anti-TP antibody used in our medical laboratory. We evaluated the fundamental performance of 4 reagents to measure anti-TP antibody concentration using latex agglutination: Reagents A, B, C and D produced by SEKISUI MEDICAL, FUJI REBIO, DENKA SEIKEN and SHINO TEST, respectively. We examined the correlations between Reagent A (routine laboratory test reagent) and Reagents B, C, and D in sera from 68 patients, and we performed additional investigation by using a neutralization test, immunochromatography, Western blotting, FTA-ABS (IgG), and STS method by an automatic analyzer for 13 decision-mismatched samples. The fundamental performance of each reagent was as good as that previously reported. Eight of the 13 decision-mismatched samples were false positives due to non-specific reaction of Reagent A. In latex agglutination non-specific reaction is inevitable. However, this study strongly suggests that using a neutralization test and immunochromatography that can be performed quickly is sufficient to verify whether positive reactions are true or false.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Ito
authors.forename: Noriyasu
authors.initials: N
authors.lastname: Niizeki
authors.forename: Hitomi
authors.initials: H
authors.lastname: Kurose
authors.forename: Takatoshi
authors.initials: T
authors.lastname: Yonezawa
authors.forename: Rie
authors.initials: R
authors.lastname: Sasaki
authors.forename: Mineji
authors.initials: M
authors.lastname: Tachibana
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Tomoda
authors.forename: Shuichi
authors.initials: S
authors.lastname: Kino
authors.forename: Satoshi
authors.initials: S
authors.lastname: Fujii
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D005189:False Positive Reactions; D006801:Humans; D007841:Latex Fixation Tests / Q000379:methods*; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D013048:Specimen Handling; D013587:Syphilis / Q000175:diagnosis*; D013588:Syphilis Serodiagnosis / Q000379:methods*; D014210:Treponema pallidum / Q000276:immunology*
chemical_list: D000907:Antibodies, Bacterial; D011933:Reagent Kits, Diagnostic