Geenius HIV 1/2 Confirm. Assay,kit/20

General Description:
Geenius HIV 1/2 Confirmatory Assay is a single-use immunochromatographic test 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. Geenius HIV 1/2 Confirmatory Assay is intended for use as an additional test to confirm the presence of antibodies to HIV-1 and HIV-2 for specimens found to be repeatedly reactive by screening assays.

Technical specifications:
Technology: Immunochromatic Assay
Format: Cassette, 20 tests
Sample type: Serum, plasma, venous whole blood, capillary whole blood
Sample volume: 15 μl
Sensitivity : 100%
Specificity : 100%
Time to result: 27 mins

Manufacturer product reference: 72460

Kit content:
1.Test device, individually packed and sealed with a desiccant, 20
2.Buffer (5 ml), 1
3.Microtubes (15 μl), 20
4.Instruction for use, 1

Materials required, provided separately:
Geenius HIV 1/2 Confirmatory Controls (Product Reference: 72329)

Items required, but not supplied:
1.Disposable gloves
2.Biohazard disposal containers
3.Clock, watch or other timing device
4.Precision pipette capable of delivering 5 μl (serum/plasma) and 15 μl (venous blood) of specimen
5.Geenius Reader with dedicated software

Shelf life:
24 months

Storage and transportation:
2 - 30 °C.

General recommendations:
1.Only initiate testing when all components of kit reach the temperature of the environment in which the test will be performed.
2.Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
3.Do not substitute reagents from other kits/batches.
4.Note that serum or plasma samples require supporting equipment and supplies, therefore a laboratory environment is recommended with adequately trained staff.

Material Safety Data Sheet (MSDS):
No environmental hazards.