DIA-HIV ½  (CE-Certificate) Enzyme immunoassay for the detection of antibodies to Hhuman Immunodeficiency Virus of 1 and 2 types (HIV-1, HIV-2)

Principle of the method: «sandwich» ELISA Clinical materials: human serum or plasma Detection of total viral specific IgG, IgM, IgA antibodies at the early stages of HIV-infection Recombinant proteins – analogues of HIV-1 antigens: env-1 (gp120, gp41), gag-1 (p24, p17) and HIV-2: env-2 (gp36) are part of immunosorbent and peroxidase conjugate Packing configuration: Strip (lockwell) or monolith microplate 96 or 192 tests TMB chromogen Incubation time: 2 hours Shelf life: 15 months

Dynamics of serological markers during HIV-infection

Assay principle Well coated with proteins env-1, env-2, gag-1		Sensitivity 100 % (873 HIV-1 positive samples, 132 HIV-2 positive samples, 37 seroconversion panels BBI, USA; AFSSAPS, France; МBC, Russia; Gromashevsky Institute of epidemiology and infectious diseases, Ukraine) Specificty 99,56 % (2 891 094 serum samples from blood donors) The test kit was evaluated at Institute of Tropical Medicine (Antwerpen, Belgium) – one of WHO collaborating centers (sensitivity 100%, specificity 98% on testing of inteferenting samples)
Adding of conjugate and sera Incubation for 90 minutes, 37°С
Adding of chromogen Incubation for 30 minutes, 18-25 °С Reaction termination Result reading

DIA-HIV-Ag/Ab - Fourth generation ELISA test kit for the   
  detection of specific antibodies to HIV 1/2 and HIV antigen (p24)

For screening and confirmatory investigations Clinical materials: human serum or plasma Detection of total viral specific IgG, IgM, IgA antibodies and p24 antigen at the early stages of HIV-infection Immunosorbent – recombinant proteins Env I and Env II and monoclonal antibodies to р24 antigen Conjugates – polyclonal antibodies labeled with biotin to p24; recombinant proteins Env I and Env II and streptavidine, conjugated with horseradish peroxidase Packing configuration: Strip (lockwell) or monolith microplate 96 or 192 tests TMB chromogen Incubation time: 1 hour 45 minutes Shelf life: 12 months Specificity 99,5 % (412 serum samples from blood donors and 220 serum samples from pregnant women) The test kit was evaluated at Institute of Tropical Medicine (Antwerpen, Belgium) (sensitivity - 100% under testing of 221 serum samples containing antibodies to HIV and antigen p24)	Assay principle
		wells coated with monoclonal antibodies to p24 and proteins - env1 and env2
		Adding of sera and the mixture of conjugates of antibodies and antigens Incubation for 60 minutes, 40-42 °С
		Adding of streptavidin conjugate Incubation for 15 minutes, 18-25 °С
		Adding of chromogen Incubation for 30 minutes, 18-25 °С Reaction termination Result reading

DIA-HIV-p24, DIA-HIV-p24-sensitive – Enzyme immunoassay for the quantitative detection of HIV 1 antigen (p24)

• Quality and quantitative assay
• Clinical materials: human serum or plasma
• Immunosorbent – monoclonal antibodies to р24 antigen
• Conjugates – polyclonal antibodies to p24 labeled with biotin and streptavidin conjugated with horseradish peroxidase
• Packing configuration:
  • Lockwell strip microplate
  • 96 tests
  • TMB chromogen
• Shelf life: 12 months
  
  

wells coated with monoclonal antibodies to р24 Adding of sera and conjugate Incubation for 120 minutes, 40-42 °С Adding of streptavidin conjugate Incubation for 15 minutes, 18-25 °С

DIA-HIV-p24 Adding of chromogen Incubation for 30 minutes, 18-25 °С Reaction termination Result reading Incubation time: 2 hours 45 minutes

DIA-HIV-p24-sensitive Adding of biotintyramine Incubation for 15 minutes, 18-25 °С Adding of streptavidin conjugate Incubation for 15 minutes, 18-25 °С Adding of chromogen Incubation for 30 minutes, 18-25 °С Reaction termination Result reading

Sensitivity: DIA-HIV-p24 – 20 pg/ml, DIA-HIV-p24-sensitive – 5 pg/ml

Specificity: DIA-HIV-p24 – 99,5 % (420 serum samples from blood donors), DIA-HIV-p24-sensitive – 98 % (270 serum samples from blood donors)

Sensitivity of DIA-HIV ½, DIA-HIV-Ag/Ab and DIA-HIV-р24 test kits at the early seroconversion stage during HIV-infection

   



* Results of testing in Abbott HIV 1/2 and Abbott HIV Ag test kits are shown from the data sheets