DIA-SYPH – Enzyme immunoassay test system for the detection of antibodies to the syphilis infectious agent Treponema pallidum

Method principle: «sandwich» ELISA Clinical materials: human serum or plasma Detection of specific IgG, IgM, IgA antibodies at early stages of syphilis infection under negative results in other serological reactions Recombinant proteins– analogues of рТр17 and рТр47 T. pallidum antigens are part of peroxidase conjugate and immunosorbent Packing configuration: strip (lockwell) or monolith microplate 96 or 192 tests TMB chromogen Incubation time: 1.5 hours Shelf life: 14 months Sensitivity – 100 % (275 serum samples form patients syphilis at different clinical stages, low titer panel PSS201, BBI, USA) Specificty – 99.1 % (2240 serum samples from blood donors and pregnant women)	Assay principle
		wells coated with monoclonal antibodies to HBsAg
		adding of controls, sera and conjugate incubation for 120 minutes, 37 °С
		adding of chromogen incubation for 30 minutes at 18-25°С reaction termination result reading

Dynamics of serological T. pallidum markers

Time after infection

DIA-IgG-IgM-Trep – the enzyme immunoassay test system for the detection of IgG and IgM classes antibodies against Treponema pallidum

Specificity – 99.3 % (1895 serum samples from blood donors and pregnant women)

DIA-Trep – the enzyme immunoassay test system for the detection of antibodies to the syphilis infectious agent Treponema pallidum

Method principle: two stage procedure based on indirect solid ELISA Clinical materials: human serum or plasma Immunosorbent – recombinant proteins – analogues of рТр 15, рТр17, рТр41 и рТр47 Treponema pallidum antigens Conjugate – monoclonal antibodies to human IgG conjugated with horseradish peroxidase Packing configuration: strip (lockwell) or monolith microplate TMB chromogen 96 or 192 tests Incubation time: 2 hours Shelf life: 12 months Sensitivity – 100 % (165 serum samples from patients with syphilis at different clinical stages, low titer panel PSS201, BBI, USA) Specificity – 99.4 % (2240 serum samples from blood donors and pregnant women)	Assay principle
		well coated with рТр15, рТр17, рТр41, рТр47 proteins
		adding of sera incubation for 60 minutes, 37°С
		adding of conjugate incubation for 30 minutes, 37°С
		adding of chromogen incubation for 30 minutes, 18-25°С reaction termination result reading

DIA-IgM-SYPH – Enzyme immunoassay for the detection of IgM class antibodies against Тreponema pallidum

The test kit is mainly intended for serological diagnostics of congenital syphilis and differential diagnostics of various syphilis stages Method principle: two stage ELISA procedure based on «IgM-capture» principle Clinical materials: human serum or plasma Immunosorbent – monoclonal antibodies to human IgM Conjugate – recombinant proteins – analogues of Тр17, рТр47 Treponema pallidum antigens conjugated with horseradish peroxidase Packing configuration: Strip microplate TMB chromogen 96 tests Incubation time: 1.5 hours Shelf life: 9 months	Assay principle
		wells coated with monoclonal antibodies to human IgM
		adding of sera incubation for 30 minutes, 37°С
		adding of conjugate incubation for 30 minutes, 37°С
		adding of chromogen incubation for 30 minutes, 18-25°С reaction termination result reading