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 (IgG,IgM & 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 and HIV-2 and is for in vitro diagnostic use only.

Salient Features

• Rapid visual test ,based on Flow Through Technology.
• Differential detection of HIV-1 & HIV-2.
• Detection of group ‘O’ & subtype ‘C’.
• Use of envelop antigens gp41& C terminus of gp120 for HIV-1 & gp36 for HIV-2.
• 100% sensitivity & 100% specificity as per WHO Evaluation.
• Shelf life 24 months at 2-8°C
• Available in convenient pack sizes- 50 Tests and 100 Tests.
• Results within 3 minutes.
• No instrument required.
• In built quality control dot.

Principle

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.

This forms a pink band indicating the sample is reactive for HBsAg. To serve as a procedural control, an additional line of anti-mouse antibody (Control line) “C”, has been immobilized at a distance from the test line on the strip. If the test is performed correctly, this will result in the formation of a pink band upon contact with the conjugate.

Evaluations

• WHO Evaluation: Evaluation report from UNAIDS (WHO), CH-1211Geneva,Switzerland Aug 1999 the Sensitivity and Specificity of HIV TRI-DOT is 100 % .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.
• NIMHANS BANGALORE: Evaluation report from National HIV Reference Laboratories of Government of India , claiming Sensitivity and Specificity of HIV TRI-DOT to be 100 %.
• CMC VELLORE: Evaluated by Department of Clinical Virology, Christian Medical College & Hospital, Vellore and published in JCM, vol. 38, Issue 2000,claiming 99.5% sensitivity and 99.9% specificity.
• NARI PUNE: Evaluation Report from National AIDS Research Institute(NARI-Pune) claiming sensitivity & Specificity to be 100 %.
• Approved by Drug Controller General of India( DCGI) for the usage in Blood Banks.

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