J. Mitra HIV Tri-Dot Kit

I. HIST Orical review and aetiology of aids (acquired immuno deficiency syndrome)
First confirmed case of Aids was identified in 1983 and by 1984 the etiologic agent, the Human Immunodeficiency Virus (HIV), subsequently named HIV-1 was isolated. Shortly afterwards in 1985 another retrovirus subsequently named HIV-2 was isolated in Africa. These two viruses belong to the retrovirus group and are slow viruses. The structure, gene organisation and serological behaviour of HIV-1 & HIV-2 and their complete nucleotide sequence has been determined. This knowledge has laid a foundation for the development of a new assay based on Recombinant DNA technology leading to the differential detection of antibodies to HIV-1 & HIV-2 (if present) in Human Serum or Plasma. Research has shown that antibodies produced against envelope gene are found in infected people as shown in graph, (Fig.-1).

HIV TRI-DOT has been developed and designed using gp41, C terminal of gp120 & gp36 representing the immunodominant regions of HIV-1 & HIV-2 envelope gene structure respectively. The device (an immunofiltration membrane) includes a "Built-in Quality Control DOT" which will develop colour during the test, thereby, confirming proper functioning of the device, reagents and correct procedural application. This Control dot is the "Built-in Quality Control." (Fig.2) HIV TRI-DOT has been specially researched, developed and engineered using several thousands of serum/plasma specimens. It has also been evaluated by UNAIDS (WHO) Geneva, using samples of European, Asian, Latin American & African origin. The Sensitivity and Specificity has been extremely high in these samples of diverse origin. The panel used for evaluation of HIV TRI-DOT by Institute of Tropical Medicine, WHO Collaborating Centre in AIDS, Belgium also included HIV-O Virus, which was found reactive with HIV TRI-DOT.

2. Intended use 

The HIV TRI-DOT Test is a visual, rapid, sensitive and accurate immunoassay for the differential detection of HIV-1 & HIV-2 antibodies (IgM, IgG & IgA) in Human Serum or Plasma using HIV-1 & HIV-2 Antigens immobilized on an immunofiltration membrane. The test is a screening test for anti-HIV-1 & antiHIV-2 and is for in vitro diagnostic use only.

3. Description of symbols used
The following are graphical symbols used in or found on J. Mitra diagnostic products and packing. These symbols are the most common ones appearing on medical devices and their packing. They are explained in more detail in the British and European Standard EN ISO 15223-1:2016.

4. Principle of the test
HIV antigens are immobilized on a porous immunofiltration membrane. Sample and reagents pass through the membrane and are absorbed into the underlying absorbent. As the patient''s sample passes through the membrane, HIV antibodies, if present, bind to the immobilized antigens. Conjugate binds to the Fc portion of the HIV antibodies to give distinct pinkish purple DOT(s) against a white background. (Fig.-3)