INSTI™ information

INSTI is a home HIV test kit. The test can determine the presence of HIV (Human Immunodeficiency Virus). NOW you can check for HIV at home in total privacy, your test results will be available to you within 60 seconds.
This product is certified and FDA approved.

General information
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 and Type 2 in human whole blood, fingerstick 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 as little as 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.

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 and Type 2 in human whole blood, fingerstick 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 as little as 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.


four simple steps

Collect 50µl of fingerstick blood, venous whole blood, serum or plasma and add bottle number 1, Sample Diluent, re-cap and invert 3-4 times.

 

1 Pour the entire contents of bottle number 1 into the center of the Membrane Unit well. HIV antibodies, if present, are captured at the test spot by proteins on the membrane.

 

2 Add the entire contents of bottle number 2, Colour Developer, into the center of the Membrane Unit well to generate a blue control spot and a second spot if HIV-1/HIV-2 antibodies are present.

 

3 Add the entire contents of bottle number 3, Clarifying Solution into center of the Membrane Unit well to reduce background colour and produce more distinct test and control spots. The control spot will appear only if human blood or blood component is present.



Advanced Diagnostic Technology

FAST

- Results in as little as 60 seconds

SIMPLE

- All reagents in ready-to-use test vials
- No measuring or drop-counting
- No timing required for test procedure
- Easy to interpret results
- No additional material required

CONVENIENT

- Utilizes fingerstick blood, venous whole blood, serum or plasma

ACCURATE

- Outstanding correlation with approved laboratory-based screening and confirmatory assays
- Unique recombinant HIV proteins yield test results of ≥ 99.8% sensitivity and ≥ 99.5% specificity

Built-in human IgG-capture control ensures test validity.



Special features of INSTI™

  • Human IgG-Capture control feature ensures proper sample addition
  • Test can be performed with human fingerstick blood, venous whole blood, serum or plasma
  • Highly accurate test results in as little as 60 seconds
  • Proven early antibody detection
  • Simple test procedure - no counting of drops, measuring or timing
  • Easy-to-interpret test results
  • Kit includes all materials necessary to perform test in any setting
  • Long shelf life, no refrigeration required


Procedure

Read the entire Package Insert (Instructions for Use) prior to beginning the test procedure.


The test is performed by adding the fingerstick blood, venous 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 into the center of the well of the Membrane Unit. HIV-1/HIV-2 antibodies, if present in the specimen, are captured by proteins on the HIV proteins on the filtration membrane. Colour Developer is then added to the Membrane Unit. The Colour Developer reacts with the captured antibodies to generate a distinct blue spot at the location of the control spot and, in the case that HIV-1/HIV-2 antibodies are present in the specimen, a blue spot also appears at the location of the test spot on the membrane. In the final step, the Clarifying Solution is added to the membrane to decrease background colour in order to make the control and test spots more distinct.


Intended for use by trained personnel in:

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




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