Alere Determine HIV 1/2, kit/100

General Description:
Alere Determine HIV 1/2, is an in vitro, rapid qualitative immunoassay, for the detection of antibodies to HIV-1 and HIV-2 in human serum, plasma, and whole blood.

Technical specifications:
Technology: Lateral immunochromatographic assay
Format: Test cards
Sample type: Whole blood, serum, plasma
Sample volume: 50µl
Sensitivity: 100%
Specificity: 98.93%
Time to result: Minimum of 15 mins and up to 60 mins

Manufacturer product reference: Alere Medical, 7D2343

Kit content:
1.10-test cards, 10
2.Instructions for use, 1

Items required, but not supplied:
1.Lancets, chase buffer and EDTA capillary tubes (for fingerstick samples)
2.Plain/dry vacuum tube (for serum samples), EDTA vacuum tube (for plasma samples), vacuum tube needle, needle holder and centrifuge.
3.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 Determine HIV 1/2 for 100 tests
Secondary packaging: One kit Alere Determine HIV 1/2, 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: