HIV Ag & Ab iClia

Intended Use

HIV Ag & Ab iClia is a Chemiluminescence microparticles immunoassay designed for in vitro qualitative detection of antibodies to HIV-1 and / or HIV-2 and HIV -1 P24 antigen in human serum or plasma and is used as a screening test for testing of collected blood prior to transfusion. This kit is only operational with J. Mitra CLIA Analyzer.

Salient Features

• 4^th Generation HIV Ag & Ab assay
• Based on Direct Sandwich Chemiluminescence Immunoassay
• Use of Envelope Antigens gp41, C terminus of gp120 for HIV-1 and gp36 for HIV-2 & simultaneously detection of p24 antigen with p24 monoclonal antibodies
• Detection of Group O & subtype C for HIV-1 prevalent in India
• Acridinium Ester (AE) based kit for more accurate results.
• Test results at 45 minutes.
• Sensitivity : 100 %
• Specificity: 100%
• Analytical Sensitivity: for p24 Antigen it is equal to 25.0 IU/ml.
• Long Shelf life: 12 months at 2-8°C.
• Onboard stability of reagents: 30 days at 2-8°C.
• Convenient Pack Size: 50 Test pack, 100 Test pack.
• Prompt Service back-up

Principle

HIV Ag & Ab iClia is chemiluminescence microparticle immunoassay based on the “Direct Sandwich” principle. The magnetic microparticles are coated with anti-HIV p24 antibody and HIV-1/-2 specific antigen. The samples are added in the wells followed by addition of AE conjugate (anti-HIV p24 antibody and HIV-1/ -2 specific antigen linked to acridinium ester). A sandwich complex is formed wherein HIV-1/2 antibody and / or HIV p24 antigen (from serum sample) is “trapped” or “sandwiched” between the microparticles coated anti-p24 antibody and HIV-1/2 antigen and anti-p24 & HIV-1/2 antigen labelled with AE conjugate. Unbound conjugate is then washed off with wash buffer. The amount of bound AE conjugate is proportional to the concentration of HIV-1/2 antibody and / or HIV p24 antigen present in the sample. Finally pre-trigger and trigger solution containing hydrogen peroxide and sodium hydroxide solution is added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative Light units (RLUs). There is a direct relationship between the amount of HIV-1/2 antibody and / or HIV p24 antigen present in the sample and the RLUs detected by the optical system. Results are calculated automatically based on the cutoff value.

Performance Characteristics

Diagnostic Sensitivity: 100 %

Diagnostic Specificity: 100%

Analytical Specificity: 100%

Analytical Sensitivity: for p24 Antigen it is equal to 25.0 IU/ml.

Precision:

1. The test results are repeatable with HIV Ag & Ab positive samples (Weak and strong) and kit controls in within run precision testing with CV <10%.
2. The test results are reproducible with HIV Ag & Ab positive samples (Weak and strong) and kit controls in between run precision testing with CV <15%.
3. The test results are reproducible with HIV Ag & Ab positive samples (Weak and strong) and kit controls in between instrument precision testing with CV <15%.

Ordering Information