HIV-1/HIV-2 Rapid Antibody Test

Health Canada approved in Canada
FDA approved in the United States
CLIA Complexity: Waived
Prequalified by World Health Organization
CE Mark Certification in the European Union*

*and other countries that accept CE mark certification.

The world’s fastest HIV test.

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, 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.

Benefits

  • Rapid: Test yields results in as little as 60 seconds
  • Flexible: Its rapid results makes it easy to include in a variety of workflow models
  • Compatible: INSTI works with most testing algorithms
  • Convenient: Stored at room temperature 15-30°C (59-86°F)

Features

  • Unique immunofiltration “flow-through” design
  • Built-in IgG capture procedural control
  • Proprietary HIV antigen
  • Lancet, pipette and alcohol swab included
  • No timers required
  • Spill-free membrane

Accuracy

Sample Type Sensitivity Specificity
Venous Whole Blood 99.9% 100%
Plasma 99.9% 100%
Fingerstick Blood 99.8% 99.5%
CLIA Fingerstick Blood* 100% 99.8%
References and Footnotes
* Galli RA, Green KF, La Marca A, et al. Evaluation of the accuracy and ease of use of a rapid HIV-1 Antibody Test performed by untrained operators at the point of care. J Clin Virol 2013;58 Suppl I:e65-9.


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IgM 2015 IAS Conference Poster

IAS 2015_IgM Poster


Results from INSTI’s Canadian Clinical Studies

Canadian Clinical Studies Results


Results from INSTI’S US Clinical Studies

US Clinical Studies Results


CLIA Poster from 2012 AIDS Conference

AIDS 2012_CLIA Poster


Number Description
90-1019 INSTI® HIV-1/HIV-2 Antibody Test: Box of 50 with Support Materials
90-1031 INSTI® HIV-1/HIV-2/HIV Negative Controls
Support Materials comprise of an alcohol swab, lancet and pipette.

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