Geenius HIV 1/2 Supplemental Assay

INTENDED USE

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, CPD, and sodium citrate). For donor testing, the assay is intended for use only with serum or plasma samples.

RESTRICTIONS

Sale of the Geenius HIV 1/2 Supplemental Assay is restricted to clinical testing laboratories that have an adequate quality assurance program, include planned systemic activities that provide confidence that quality requirements are met, and ensure that operators receive and use instructional materials.

Results of the Geenius HIV 1/2 Supplemental Assay are read and interpreted only with the Geenius Reader with dedicated software.