Diagnos HIV BI-DOT

Intended Use

The Diagnos HIV BI-DOT Test is a visual, rapid, sensitive and accurate immunoassay for the 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 and HIV-2 and is for in vitro diagnostic use only.

Salient Features

• Rapid visual test ,based on Flow Through Technology.
• Detection of group ‘O’ & subtype ‘C’ strain of HIV-1 prevalent in Asian subcontinent.
• Use of Envelope antigen; gp41& C terminus of gp120 for HIV-1 & gp36 for HIV-2.
• Shelf life 24 Months at 2-8°C.
• 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 antibodies to give distinct pinkish purple DOT against a white background.

Ordering Information

Evaluations

• NARI PUNE: Performance of the test has been determined by National Aids Research Institute(NARI), Pune.The result are as follows:Sensitivity – 100 % and Specificity – 100 %
• Approved by Drug Controller General of India( DCGI) for the usage in Blood Banks.