SD Bioline HIV 1/2, 3.0, kit/30

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

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Lateral flow cassette, 30 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), 03FK10.

Items supplied with:
1.Cassettes individually foil pouched with a desiccant, 30
2.Assay diluent 4 ml (buffer), 1 bottle
3.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), safety lancet, alcohol swab, specimen transfer device.
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: 0.304 kg
Estimate Volume: 1.615 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 for 30 tests
Secondary packaging: One kit SD Bioline HIV 1/2, 3.0, 30 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/