One Step HIV1/2, nonsafetylancet,kit/25T

General description:
One Step HIV 1/2 Whole Blood/Serum/Plasma is a rapid, in vitro immunochromatographic direct binding test for detection of HIV 1/2 antibodies in human venous whole blood, fingerstick whole blood, serum or plasma, aid to diagnosis of HIV infection. It is intended for use by trained users (in either laboratory or point-of-care settings).

Technical specifications:
Technology: Lateral flow immunochromatographic assay
Specimen type: Serum, plasma, venous and capillary whole blood
Clinical sensitivity: 100.0%
Clinical specificity: 100.0%
Time to result: 15 minutes. Do not wait more than 30 minutes.

Manufacturer product reference: Guangzhou Wondfo Biotech Co., Ltd, W006-P0045

Items supplied with:
·Individual pouches, each contains: 1 test cassette, 1 dropper and 1 desiccant, 25
·Assay buffer bottle (5 ml), 1
·Sterile non-safety lancets, 25
·Alcohol swabs, 25
·IFU, 1

Items required, but not supplied:
Specimen collection containers, centrifuge (for serum/plasma specimen only), capillary tube (for fingerstick whole blood only), timer, protective gloves, specimen and test waste container

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

Weight and volume:
Estimated weight: 0.26kg
Estimated volume: 1.792dm³

Storage and transportation condition:
The test kit and sample diluent should be stored at 2 to 30°C. Protect against humidity and direct sunlight. Do not freeze.

Packaging and labeling:
Primary packaging: All contents of One Step HIV1/2 Whole Blood/Serum/Plasma Test with sterile non-safety lancet for 25 tests
Secondary packaging: One kit One Step HIV1/2 Whole Blood/Serum/Plasma Test with sterile non-safety lancet, 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.
·Do not use the kit if pouch is punctured or not well sealed.
·Do not mix buffer/test devices from different kit lots.
·Apply standard biosafety precautions when handling and disposing of potentially infectious material.

Useful links:
WHO PQ Public report