title: Evaluation of new automated syphilis test reagents 'IMMUNOTICLES AUTO3' series: performance, biochemical reactivity, and clinical significance.
abstract: BACKGROUND
  Automated nontreponemal and treponemal test reagents based on the latex agglutination method (immunoticles auto3 RPR: ITA3RPR and immunoticles auto3 TP: ITA3TP) have been developed to improve the issues of conventional manual methods such as their subjectivity, a massive amount of assays, and so on. We evaluated these reagents in regards to their performance, reactivity to antibody isotype, and their clinical significance.
  
  
  METHODS
  ITA3RPR and ITA3TP were measured using a clinical chemistry analyzer. Reactivity to antibody isotype was examined by gel filtration analysis.
  
  
  RESULTS
  ITA3RPR and ITA3TP showed reactivity to both IgM- and IgG-class antibodies and detected early infections. ITA3RPR was verified to show a higher reactivity to IgM-class antibodies than the conventional methods. ITA3RPR correlated with VDRL in the high titer range, and measurement values decreased with treatment. ITA3RPR showed a negative result earlier after treatment than conventional methods. ITA3TP showed high specificity and did not give any false-negative reaction. Significant differences in the measurement values of ITA3RPR between the infective and previous group were verified.
  
  
  CONCLUSIONS
  The double test of ITA3RPR and ITA3TP enables efficient and objective judgment for syphilis diagnosis and treatments, achieving clinical availability.
authors.affiliation: Department of Medical Technology Science, Saitama Prefectural University, 820, San-Nomiya, Koshigaya-shi, Saitama, 343-8540, Japan. Electronic address: yukimasa-nobuyasu@spu.ac.jp.
authors.forename: Nobuyasu
authors.initials: N
authors.lastname: Yukimasa
authors.affiliation: R&D Unit, A&T Corporation, 2023-1, Endo, Fujisawa-shi, Kanagawa, 252-0816, Japan. Electronic address: miurak@alice.aandt.co.jp.
authors.forename: Keisuke
authors.initials: K
authors.lastname: Miura
authors.affiliation: R&D Unit, A&T Corporation, 2023-1, Endo, Fujisawa-shi, Kanagawa, 252-0816, Japan. Electronic address: miyagaway@alice.aandt.co.jp.
authors.forename: Yukiko
authors.initials: Y
authors.lastname: Miyagawa
authors.affiliation: Department of Clinico-diagnostic Pathology, Showa University, School of Medicine, 1-5-8, Hatanodai, Shinagawa-ku, Tokyo, 142-8666, Japan. Electronic address: kfukuchi@med.showa-u.ac.jp.
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Fukuchi
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D001331:Automation / Q000379:methods*; D001431:Bacteriological Techniques / Q000379:methods*; D006801:Humans; D007202:Indicators and Reagents; D007841:Latex Fixation Tests / Q000379:methods*; D013587:Syphilis / Q000175:diagnosis*; D014210:Treponema pallidum / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D007202:Indicators and Reagents
keywords: Automated test; Biochemical reactivity; Clinical significance; Diagnosis algorithm; Latex agglutination; Syphilis