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.
|Venous Whole Blood||99.4%||99.7%|
|90-1012||INSTI® HIV-1/HIV-2 Antibody Test: Box of 50 with Support Materials|
|90-1022||INSTI® HIV-1/HIV-2 Antibody Test: Box of 48 Tests with Support Materials|
|90-1021||INSTI® HIV-1/HIV-2 Antibody Test: Box of 48 Tests without Support Materials|
|90-1034||INSTI® HIV-1/HIV Negative Controls|
|90-1035||INSTI® HIV-1/HIV-2/HIV Negative Controls|