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*
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.
For more information, visit insti.com
Sample Type | Sensitivity | Specificity |
---|---|---|
Venous Whole Blood | 99.4% | 99.7% |
Plasma | 99.5% | 99.96% |
Fingerstick Blood | 99.6% | 99.3% |
Serum | 99.0% | 100% |
Canadian Clinical Studies Results
Number | Description |
---|---|
90-1008 | INSTI® HIV-1/HIV-2 Antibody Test: Box of 50 with Support Materials |
90-1034 | INSTI® HIV-1/HIV Negative Controls |
90-1035 | INSTI® HIV-1/HIV-2/HIV Negative Controls |