Nobuyasu Yukimasa1, Keisuke Miura2, Yukiko Miyagawa3, Kunihiko Fukuchi4. 1. Department of Medical Technology Science, Saitama Prefectural University, 820, San-Nomiya, Koshigaya-shi, Saitama, 343-8540, Japan. Electronic address: yukimasa-nobuyasu@spu.ac.jp. 2. R&D Unit, A&T Corporation, 2023-1, Endo, Fujisawa-shi, Kanagawa, 252-0816, Japan. Electronic address: miurak@alice.aandt.co.jp. 3. R&D Unit, A&T Corporation, 2023-1, Endo, Fujisawa-shi, Kanagawa, 252-0816, Japan. Electronic address: miyagaway@alice.aandt.co.jp. 4. 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.
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.
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.