The INSTI™ HIV-1/HIV-2* Rapid Antibody Test is a rapid in vitro qualitative test for the detection of antibodies to Human Immunodeficiency Virus Type 1 in human whole blood, serum or plasma. The test is intended for use by trained personnel in medical facilities, clinical laboratories, emergency care situations, and physicians' offices as a screening assay capable of providing test results in less than 60 seconds. The assay is packaged as a kit containing INSTI™ Membrane Units, Sample Diluent, Color Developer and Clarifying Solution, and is available in point-of-care use packaging, or packaging suitable for laboratory use.

1 Add 50µl of blood, serum or plasma with pipette to the Sample Diluent.

2 Pour the diluted sample into the Membrane Unit.

3 Re-suspend the Color Developer and add it to the Membrane Unit.

4 Add the Clarifying Solution.

FAST	Results in 60 seconds
SIMPLE	- All reagents in ready-to-use test vials - No measuring or drop counting - No contamination - No timing required - No additional material required
CONVENIENT	Utilizes EDTA whole blood, finger stick blood, serum or plasma
ACCURATE	Excellent correlation with Western Blot Test and ELISA Test
SENSITIVE & SPECIFIC	Recombinant HIV proteins offer a 99.96% combined accuracy

Built-in true human IgG control assures test validity.

• Built-in true human IgG control
• Use 50µl of EDTA whole blood, finger stick blood, serum or plasma
• Rapid results at a glance (60 seconds)
• Proven early antibody detection
• Large scale Canadian clinical trial data shows a 99.96% combined accuracy
• Easy to understand instructions
• No timing required
• No refrigeration required
  

The test is performed by adding the whole blood, serum or plasma specimen to the vial of Sample Diluent which lyses the red blood cells. This specimen/diluent solution is then poured onto the well of the Membrane Unit. HIV-1/HIV-2* antibodies, if present in the specimen, are captured by proteins on the filtration membrane. Color Developer is then added to the Membrane Unit. The Color Developer reacts with the captured antibodies to generate a distinct blue dot at the location of the control spot and, in the case that HIV-1/HIV-2* antibodies are present in the specimen, a blue dot also appears at the location of the test spot on the membrane. In the final step, the Clarifying Solution is then added to the membrane to decrease background color in order to make the control and test spots more distinct.

• Medical facilities by trained personnel
• Clinical laboratories
• Emergency care situations
• Physicians' offices
• Voluntary Counseling and Testing (VCT) programs
  

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