HIV Microlisa 3.0

Intended Use

HIV Microlisa 3.0 is an in-vitro qualitative enzyme immunoassay for the detection of IgM, IgG & IgA antibodies to HIV-1 and / or HIV-2 in human serum or plasma. It is intended for screening of blood donors or other individuals at risk for HIV-1 and / or HIV-2 infection and for clinical diagnostic testing.

Salient Features

• 3rd Generation ELISA kit for detection of IgM,IgG & IgA antibodies to HIV -1& HIV-2 in Human serum /Plasma
• Use of Envelope Antigens gp41,C terminus of gp120 for HIV-1& gp36 for HIV-2
• Detection of Group O & subtype C for HIV-1 prevalent in India
• Color coded reagents to monitor procedural steps
• Assay procedure: 90 mins.
• Longer shelf life: 12 months at 2-8°C.
• Sensitivity 100% & Specificity 99.2%
• Approved by Drug Controller General of India (DCGI) for the usage in Blood Banks.

Principle

HIV Microlisa 3.0 test is an enzyme immunoassay based on Indirect ELISA. HIV envelope proteins proteins gp41, C terminus of gp 120 for HIV-1, and gp 36 for HIV-2 representing immunodominant epitopes are coated onto microtiter wells. Specimens and controls are added to the microtiter wells and incubated. Antibodies to HIV-1 and HIV-2 if present in the specimen, will bind to the specific antigens absorbed onto the surface of the wells. The plate is then washed to remove unbound material. Horseradish peroxidase (HRP) conjugated gp41, C ter of 120 of HIV-1 and gp36 of HIV-2 is added to each well.

This conjugate will bind to HIV antigen-antibody complex present. Finally substrate solution containing chromogen and hydrogen peroxide is added to the wells and incubated. A blue colour will develop in proportion to the amount of HIV-1 and / or HIV-2 antibodies present in the specimen. The colour reaction is stopped by a stop solution. The enzyme substrate reaction is read by EIA reader for absorbance at a wavelength of 450 nm. If the sample does not contain HIV-1 or HIV-2 antibodies then enzyme conjugate will not bind and the solution in the wells will be either colourless or only a faint background colour develops.

Ordering Information

Performance Characteristics

The performance of HIV MICROLISA 3.0 has been evaluated in house with fresh as well as frozen samples. The testing has been done with clinical samples, samples from random blood donors, cross reacting samples; RA, CRP, ASO and patients with diseases related to HIV. The results of in-house studies are as follows:

Sensitivity: 100%
Specificity: 99.92%