SDBioline HIV1/2, 3.0 wsafetylnct,kit/25

General Description:
SD Bioline HIV 1/2, 3.0, is a rapid immunochromatographic assay, for the detection of antibodiesto all isotypes (IgG, IgM, IgA) specific to HIV-1 including subtype-O and HIV-2 simultaneously.
Minimum order quanity is 2,000 kits.

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Lateral flow cassette, 25 tests
Sample type: Whole blood, serum, plasma
Sample volume: 20µl
Sensitivity: 100%
Specificity: 99.8%
Time to result: 10 - 20 mins

Manufacturer product reference: Standard Diagnostics (SD), 03FK17.

Items supplied with:
1.Cassettes individually foil pouched with a desiccant, 25
2.Assay diluent 4 ml (buffer), 1 bottle
3.Specimen transfer devices (20µl) , 25
4.Safety lancets, 25
5.Alcohol swabs, 25
6.Instructions for use, 1

Items required, but not supplied:
1.Plain/dry vacuum tube (for serum samples), EDTA vacuum tube (for plasma samples), vacuum tube needle, needle holder, centrifuge and precision pipette plus tips (if whole blood is collected by venipuncture)
2.Disposable gloves, sterile gauze, anti-septic swabs, absorbent paper, protective glasses, timer, container for biohazard disposables and disinfectant (for surfaces).

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

Weight and Volume:
Estimate Weight: 0.308 kg
Estimate Volume: 1.686 dm3

Storage and transportation:
Between 1 - 30°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of SD Bioline HIV 1/2, 3.0 with safety lancet for 25 tests
Secondary packaging: One kit SD Bioline HIV 1/2, 3.0 with safety lancet, 25 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:
http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/