Genie Fast HIV 1/2, kit/50

General description:
Genie Fast HIV 1/2 Assay is a rapid immunochromatographic assay intended for the detection of antibodies to HIV-1 and HIV-2 in capillary whole blood, venous whole blood, serum or plasma all of human origin. It is a qualitative assay used as an aid to diagnose HIV infection.

Intended Use:
The test is suitable for use in multi-test algorithms designed for the validation of rapid HIV test results. When multiple rapid HIV tests are available, this test can be used in
appropriate multi-test algorithms.

Technical specifications:
Rapid Immunochromatographic assay.
Test format: Cassette.
Sensitivity: 100%
Specificity: 98.5%
Invalid rate: 0.1%
Specimen type: Venous whole blood, capillary whole blood, serum, or plasma specimens.
Specimen volume: 80μl
Time to results: 11 mins.

Manufacturer product reference:
Bio-Rad, 72330.

QMS/Regulatory information:
·ROW (Rest-of-World)
·ISO 13845:2016
·WHO Pre-Qualified product

Items supplied with:
50 x Test device pouch containing: 1 test device and 1 desiccant.1 Diluent bottle (5.0ml)
50 x Disposable transfer pipettes, plastic
1 x IFU.

Items required, but not supplied:
Safety lancet, alcohol swab, micro safe for fingerstick protocol, clock or timer, specimen collection container, centrifuge, biohazard waste container.

Shelf life:
15 months

Weight and Volume:
Estimated Weight: 0.577 kg.
Estimated Volume: . 7.25 dm3.

Storage and temperature instructions:
2 to 30°C (the kit and every item in the kit).

Packaging and labeling:
Primary packaging: All contents of Genie Fast HIV 1/2 test 50 tests.
Secondary packaging: One kit Genie Fast HIV 1/2 test, 50
tests.

General recommendations:
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).
Do not use any other specimen than those specified.
Apply standard biosafety precautions when handling and disposing of potentially infectious material.

Useful links:
Public reports of WHO prequalified in vitro diagnostic products.