ONE STEP Anti-HIV (1&2) w/o acc, kit/25

General description:
The ONE STEP Anti-HIV (1&2) Test is a colloidal gold enhanced, rapid immunochromatographic assay for qualitative detection of antibodies to Human Immunodeficiency Virus (HIV) in human whole blood (venous and fingerstick), serum or plasma. This test is intended for healthcare professionals and trained healthcare workers to use as an aid in HIV infection diagnosis of adult healthcare patients.

Technical specifications:
Sensitivity: 100.0%
Specificity: 100.0%
Invalid rate: 0%
Time to result: 15-20 minutes
Specimen type: Serum, plasma, venous whole blood, capillary whole blood

Manufacturer product reference: InTec PRODUCTS, INC., ITPW02152-TC25

Items supplied with:
·Test cassette, foil pouch sealed with a desiccant, 25
·Dropper, 25
·Sample diluent bottle (2ml), 3
·Instructions for Use (IFU), 1

Items required, but not supplied:
Sterile lancets, alcohol pads, blood sampling tools (sterile gauze pad, venous puncture device, collection tube with EDTA/heparin sodium/sodium citrate for whole blood or plasma, collection tube with no anticoagulant for serum) timer, disposable protective gloves, biohazard waste container

Shelf life:
24 months from the date of manufacturing; do not use beyond its expiry date.

Weight and volume:
Estimated weight: 0.29 kg
Estimated volume: 0.0015 m³

Storage and transportation condition:
Between 2 to 30 °C. Protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of ONE STEP Anti-HIV (1&2) without accessories for 25 tests
Secondary packaging: One kit ONE STEP Anti-HIV (1&2) without accessories, 25 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:
WHO list of prequalified in vitro diagnostic products: