ABON HIV 1/2/O Tri-Line, kit/40

General Description:
ABON HIV 1/2/O Tri-Line, is a rapid immunochromatographic assay, HIV1/2/O tri-line for the qualitative detection of antibodies to HIV-1,including subtype O, and HIV-2.

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Lateral flow cassette, 40 tests
Sample type: Venous and capillary whole blood, serum and plasmaspecimens
Sample volume: 25µl (serum/plasma); 50µl (whole blood)
Sensitivity: 100%
Specificity: 99.7%
Time to result: 10 mins

Manufacturer product reference: ABON Biopharm Hangzhou Co., Ltd.,IHI-T402WA

Kit content:
1.Pouched test devices with desiccant, 40
2.Specimen droppers, 40
3.Buffer, 2 bottles (3 ml/vial)
4.Instructions for use, 1

Items required, but not supplied:
Specimen collection equipment and containers; disposable gloves; sterilesingle-use lancets; alcohol swabs; heparinized capillary tubes with 50μLmark line; timer; biohazard waste containers for sharps and non sharps;centrifuge

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

Storage:
Between 2 – 30°C, protected against humidity and direct sunlight. Do notfreeze reagents.

Packaging and labeling:
Primary packaging: All contents of ABON HIV 1/2/O Tri-Line for 40 tests
Secondary packaging: One kit ABON HIV 1/2/O Tri-Line, 40 tests

Weight and volume:
Estimated weight: 0.38 Kg
Estimated volume: 2.06 dm³

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

Useful links:
WHO list of prequalified in vitro diagnostic products:
http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/