DIAGNOSTICS of TоRCH-infections:  
  Toxoplasmosis, Rubella, Cytomegalovirus and Herpes Simplex Virus

Diaproph-Med manufactures the test kit  based on immunoassay  for serological diagnostics of TоRCH-infections, which includes the following test systems:
DIA-Toxo-IgG, DIA-Toxo-IgM, DIA-Rubella-IgG, DIA-Rubella-IgM, DIA-CMV-IgG, DIA-CMV-IgM, DIA-HSV ½-IgG, DIA-HSV ½-IgМ, DIA-HSV 2-IgG, DIA-HSV 2-IgМ

Test kits for diagnostics of toxoplasmosis

DIA-Toxo-IgG – Enzyme immunoassay for the quantitative detection of IgG class antibodies against Toxoplasma gondii.

DIA-Toxo-IgМ – Enzyme immunoassay for the detection of IgM class antibodies against Toxoplasma gondii.

DIA-Toxo-IgG Principle of the method: two stage procedure based on indirect solid ELISA Clinical materials: human serum or plasma Quantitative detection of the concentration of specific to Тoxoplasma gondii IgG antibodies in International Units (IU) Included calibrators in the test kit are tittered against 3 International standards Anti-Toxoplasma serum, Human Immunosorbent – purified specific antigens of Toxoplasma gondii. Conjugate – high specific monoclonal antibodies to human IgG antibodies conjugated with horseradish peroxidase Packing configuration: strip (lockwell) microplate TMB chromogen 96 tests Incubation time: 2 hours Shelf life: 12 months Assay principle wells coated with purified antigens of Toxoplasma gondii 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-Toxo-IgМ Principle of the method: two stage ELISA procedure based on «IgM-capture» principle Clinical materials: human serum or plasma Detection of specific to Toxoplasma gondii IgM antibodies Immunosorbent – monoclonal antibodies to human IgM Conjugate – purified membrane antigen of Toxoplasma gondii conjugated with horseradish peroxidase Packing configuration: strip (lockwell) microplate TMB chromogen 96 tests Incubation time: 2 hours Shelf life: 12 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 Results of testing on serum panels containing and not containing antibodies to Toxoplasma gondii in mixed titers - Anti-Toxoplasma Mixed Titer Performance Panel PTT201, manufactured by BBI (USA) and positive controls Accurun 135 Toxo IgG Positive Control (BBI, USA) and Accurun 136 Toxo IgМ Positive Control (BBI, USA) in DIA-Toxo-IgG and DIA-Toxo-IgМ test kits are correspond to the data sheets. Registration rate of IgG to T.gondii in different age groups Diagnostics of toxoplasmosis from pregnant women: strategy of monitoring (WHO recommendation) – initial testing. Table 2 Variant of investigation Result of IgG detection ( IU / ml ) Result of IgM detection Interpretation Recommendations Variant А Negative <6 Negative   Absence of i mmunity ( group of risk ) During pregnancy blood should be tested in each 4 weeks Variant В 1 Positive 6 < IU < 200 Negative   P rotective immunity ( after undergone infection ) Repeated investigation of serrum in 2-3 weeks for confirmatory of protective immunity Variant В 2 Positive >200 Negative   S uspicion of seroconversion Repeated investigation of serrum in 2-3 weeks for IgM , Ig А antibodie presence Variant В 3 Positive >6 Positive S uspicion of seroconversion Repeated investigation of serrum in 2-3 weeks Variant С Negative <6 Positive S uspicion of seroconversion Repeated investigation of serrum in 2-3 weeks Diagnostics of toxoplasmosis from pregnant women: strategy of monitoring (WHO recommendation) – repeated testing. Table 2 Variant of investigation Result of IgG detection ( IU / ml ) Result of IgM detection Interpretation Recommendations Variant Ва Positive ( increasing of the concentration in twice and more ) Positive Seroconversion Confirmation in others test kits and also IgA detection Variant В b Positive ( without changing of the concentration ) Positive P rotective immunity ( after undergone infection more than 2 months ago ) Investigate in 2- 3 weeks for the purpose of confirmation of protective immunity Variant Са Positive >6 Positive Seroconversion Confirmation in others test kits and also IgA detection Variant С b Negative <6 Positive Absence of i mmunity ( group of risk ) During pregnancy blood should be tested in each 4 weeks ( nonspecific antibodies ). * Dubins’ka G.M., Izums’ka О.М., Kozuk P.М., etc. Toxoplasmosis. Clinic, diagnostics and treatment. //Infectology. Guide of specialist. January, 2003, №1 (129).

Test kits for the diagnostics of rubella virus
DIA-Rubella-IgG – Enzyme immunoassay for the quantitative detection of IgG class antibodies against Rubella Virus
DIA-Rubella-IgМ – Enzyme immunoassay for the detection of IgM class antibodies against Rubella Virus

DIA-Rubella-IgG Principle of the method: two stage procedure based on indirect solid ELISA Clinical material: human serum or plasma Quantitative detection of the concentration of specific IgG antibodies to Rubella virus in International units (IU) Internal calibrators of the kit are titrated against 1 International standard Anti-Rubella Immunoglobulin, Human, RUBI-1-94 Immunosorbent – purified specific antigens of Rubella virus Conjugate – high specific monoclonal antibodies to human IgG antibodies conjugated with horseradish peroxidase Packing configuration: strip (lockwell) microplate TMB chromogen 96 tests Incubation time: 1,5 hours Shelf life: 12 months Assay principle wells coated with specific antigens of Rubella virus adding of sera and controls 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 DIA-Rubella-IgМ Principle of the method: two stage ELISA procedure based on «IgM-capture» principle Clinical materials: human serum or plasma Detection of specific to Rubella virus IgM antibodies Immunosorbent – monoclonal antibodies to human IgM Conjugate – purified antigen of Rubella virus conjugated with horseradish peroxidase Packing configuration: strip (lockwell) microplate TMB chromogen 96 tests Incubation time: 1,5 hours Shelf life: 12 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 Results on testing of serum panels containing antibodies to Rubella virus in mixed titers: anti-Rubella Mixed Titer Performance Panel PTR201, manufactured by BBI (USA) and positive controls Accurun 140 Rubella IgG Positive Control (BBI, USA) and Accurun 141 Rubella IgM Positive Control (BBI, USA) in DIA-Rubella-IgG and DIA-Rubella-IgМ test kits are correspond to the data sheets. Registration rate of IgG to T.gondii in different age groups

Test kit for the diagnostics of herpes virus infection and differential diagnostics of genital herpes virus.
DIA-HSV 1/2-IgG – Enzyme immunoassay for the qualitative and semiquantitative detection of IgG class antibodies against Herpes Simplex Virus 1 and 2 types
DIA-HSV 1/2-IgМ – Enzyme immunoassay for the detection of IgM class antibodies against Herpes Simplex Virus 1 and 2 types
DIA-HSV 2-IgG – Enzyme immunoassay for the qualitative and semiquantitative detection of IgG class antibodies against Herpes Simplex Virus 2 type
DIA-HSV 2-IgМ – Enzyme immunoassay for the detection of IgM class antibodies against Herpes Simplex Virus 2 type

Structure of Herpes Simplex Virus

DIA- HSV 1/2-IgG and DIA- HSV 2-IgG Principle of the method: two stage ELISA based on «IgM-cupture» principle Clinical materials: human serum or plasma DIA-HSV ½-IgM: Detection of specific IgM antibodies to herpes simplex virus 1 and 2 types DIA-HSV 2-IgM: Detection of specific IgM antibodies to herpes simplex virus 2 type Immunosorbent – monoclonal antibodies to human IgM Conjugate: DIA-HSV ½-IgM: specific purified recombinant antigens gG1 HSV1 and gG2 HSV2 conjugated with horseradish peroxidase; DIA-HSV 2-IgM: specific purified recombinant antigen of herpes simplex virus 2 (gG2) conjugated with horseradish peroxidase Packing configuration: strip (lockwell) microplate TMB chromogen 96 tests Incubation time: 2 hours Shelf life: 12 months Assay principle wells coated with antigens of herpes simplex virus 1 and 2 adding of sera and controls 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-HSV 1/2-IgМ and DIA-HSV 2-IgM Principle of the method: two stage ELISA procedure based on «IgM-capture» principle Clinical materials: human serum or plasma Detection of specific to Rubella virus IgM antibodies Immunosorbent – monoclonal antibodies to human IgM Conjugate – purified antigen of Rubella virus conjugated with horseradish peroxidase Packing configuration: strip (lockwell) microplate TMB chromogen 96 tests Incubation time: 1,5 hours Shelf life: 12 months Assay principle wells coated with monoclonal antibodies to human IgM 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 Results obtained during testing of serum panels containing of antibodies to herpes simplex virus 1 and 2 in mixed titers - Anti-HSV type 1and 2 Mixed Titer Performance Panel PTH201, manufactured by BBI (USA) and Accurun 150 HSV IgG Positive Control (BBI, USA) in DIA-HSV ½-IgG and DIA-HSV ½-IgМ kits are correspond to the data sheets. Dynamics of serological markers during herpes infection