Alere HIV Combo, kit/100

General Description:
Alere HIV Combo is an in vitro, visually read, rapid qualitative immunoassay, for the detection of antibodies to HIV-1 and HIV-2 and the detection of non-immunocomplexed (free) HIV-1 p24 antigen in human serum, plasma, and capillary and venous whole blood.

Technical specifications:
Technology: Lateral immunochromatographic assay
Format: Test cards, 100 tests
Sample type: Whole blood, serum, plasma
Sample volume: 50µl
Sensitivity: 100%
Specificity: 99.4%
Time to result: Minimum of 20 mins and up to 40 mins

Manufacturer product reference: Alere Medical, 7D2843

Kit content:
·10 test cards of 10 tests each
·1 Instructions for use

Items required, but not supplied:
·Sterile lancets, chase buffer and EDTA capillary tubes (for fingerstick samples)
·Plain/dry vacuum tube (for serum samples), EDTA vacuum tube (for plasma samples), vacuum tube needle, needle holder and centrifuge.
·Disposable gloves, sterile gauze, alcohol swabs, timer, container for biohazard disposables

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

Storage and transportation:
Between 2 - 30°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of Alere HIV Combo for 100 tests
Secondary packaging: One kit Alere HIV Combo, 100 tests

Weight and volume:
Estimated weight: 0.33 Kg
Estimated volume: 0.50 dm³

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:
http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/