The Geenius™ HIV 1/2 Supplemental Assay is a single-use immunochromatographic assay for the confirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum, or plasma samples (EDTA, heparin, and sodium citrate).
The Geenius™ HIV 1/2 Supplemental Assay is intended for use as an aid in the diagnosis of infection with HIV-1 and/or HIV-2. It is intended for use as an additional, more specific test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens found to be repeatedly reactive by diagnostic screening procedures. The assay may also be used to confirm the presence of antibodies to HIV-1 and/or HIV-2 in pediatric subjects (i.e., children as young as 2 years of age).
The results of the Geenius™ HIV 1/2 Supplemental Assay are read and interpreted only by the Geenius™ Reader with dedicated software.
- Sale of the Geenius™ HIV 1/2 Supplemental Assay is restricted to clinical laboratories that have an adequate quality assurance program, including planned systematic activities to provide adequate confidence that requirements for quality will be met and where there is assurance that operators will receive and use the instructional materi- als.
- The Geenius™ HIV 1/2 Supplemental Assay is approved for use only by an agent of a clinical laboratory.
- The Geenius™ HIV 1/2 Supplemental Assay is not approved for testing of specimens from blood, plasma, cell, or tissue donors that are repeatedly reactive on HIV-1/2 donor screening assays.
Geenius™ HIV 1/2 Supplemental Assay is a complete system for HIV-1 and HIV-2 antibody confirmation and differentiation in serum, plasma or whole blood (venous and fingerstick), providing automated reading and interpretation of the results in 30 minutes.