Diagnostic kit for HIV (1+2)Ab,Kit/50

General Description:
Diagnostic Kit for HIV (1+2) Antibody (Colloidal Gold) V2 is an in vitro, visually read test for the qualitative determination of antibodies against HIV-1 and HIV-2 in human serum, plasma, venous and capillary whole blood. This product is intended for use as an aid to detect antibodies against HIV (1+2) from individuals suspected to be infected by HIV. It is intended to be used by laboratory professional and health care workers at point-of-care

Technical specifications:
Technology: Immunochromatographic technology
Format: Cassette, 50 tests
Sample type: Whole blood, serum and plasma
Sample volume: 40µl
Sensitivity: 100%
Specificity: 100%
Invalid rate: 0%
Reading time: 15-25 mins

Manufacturer product reference: R-401-50-C-2

Components of the test kit:

1.50, test cassettes
2.1, sample diluent bottle (4 ml)
3.50, safety lancets
4.50, alcohol swabs
5.50, disposable transfer pipettes
6.1, IFU - Instructions for use

Items required, but not supplied:
Timer, specimen transfer device (graduated), tips (pipettes), collection tube, biohazard waste container and gloves.

Shelf life:
24 months for test cassettes and sample diluent bottle from the date of manufacturing.
18 months for accessories (safety lancets, alcohol swabs and disposable transfer pipettes) from the date of manufacturing.

Weight and Volume:
Estimated Volume: 0.0054 m3
Estimated Weight: 0.84 kg

Storage and transportation:
Between 4 - 30°C

Packaging and labeling:
Primary packaging: All contents of Diagnostic Kit for HIV (1+2) Ab for 50 tests

Secondary packaging: One kit Diagnostic Kit for HIV (1+2) Ab, 50 tests

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

Useful links:
WHO list of prequalified in vitro diagnostic products