INTRODUCTION: Novala HIV-1 and HIV-2 Test Kit is a rapid, 3rd generation, qualitative, sandwich immunoassay designed for the simultaneous and differential detection of total antibodies (IgG, IgM, IgA, etc.) to HIV-1 and HIV-2 viruses in human serum/plasma.
SUMMARY AIDS is caused by at least two retroviruses, HIV-1 and HIV-2, collectively referred to as HIV-1/2. Individuals with AIDS, ARC, or at high risk of contracting AIDS often have antibodies to HIV-1 core protein p24, transmembrane protein (gp41), and/or antibodies to HIV-2 transmembrane protein (gp36) in their sera. Detection of these antibodies indicates exposure to the HIV-1/2 virus.
PRINCIPLE:
NOVALA HIV-1 and HIV-2 Test Kit utilizes the principle of agglutination of antibodies/antisera with their respective antigens in an immunochromatography format. Nano gold particles are used as the agglutination revealing agent. The membrane of the test kit contains highly purified antigens representing HIV-1 (gp41, gp120, and p24-O fusion polypeptide), HIV-1 group “O,” and synthetic peptide gp36 representing HIV-2. These antigens are coated as two separate test bands. An assay control forms the third band. Similar antigens are also coated on colloidal gold. A unique combination of synthetic peptides and recombinant antigens reduces cross-reactivity, enabling better discrimination between HIV-1 and HIV-2 samples.
During the test, the HIV-1/2 antigens-colloidal gold conjugate complexes with the HIV-1/2 specific antibodies in the specimen, and both travel on the membrane due to capillary action along with the rabbit globulin-colloidal gold conjugate. The complex is immobilized by the HIV-1/2 antigens coated on the membrane at two separate test regions for HIV-1 and HIV-2, forming colored bands. The presence of colored bands in the test regions indicates the presence of antibodies to HIV-1/2 in the specimen. The unreacted conjugate and unbound complex, along with the rabbit globulin-gold conjugate, move further on the membrane and are subsequently immobilized by the agglutinating sera for rabbit globulin coated on the membrane at the control region (C), forming a colored band. This control band acts as a procedural control and validates the results.
PRECAUTIONS:
- For in-vitro diagnostic use only.
- Do not use after the expiration date.
- Avoid eating, drinking, or smoking in the area where specimens and kits are handled.
- Handle all specimens as if they contain infectious agents. Follow established precautions against microbiological hazards and use proper disposable capillary tubes.
- Wear protective clothing such as laboratory coats, disposable gloves, and eye protectors during specimen handling.
- Be aware that humidity and temperature can affect test results.
- All positive results must be confirmed by an alternate method.
- Autoclave the cassette used for testing before disposal.
SPECIMEN COLLECTION AND PREPARATION:
- Collect samples following correct medical practices.
- For fingerprick whole blood samples, clean the finger with an alcohol swab, use a sterile blood lancet to puncture the center of the finger pad skin, hold the finger downward, and drip the blood into the test cassette’s sample well. Alternatively, draw the blood with a capillary tube if dripping is not possible.
- For venipuncture whole blood samples,