Sure Check HIV 1/2, kit/25

General Description:
Sure Check HIV 1/2, is a rapid immunochromatographic assay, for the detection of antibodies to HIV Types 1 and 2.

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Lateral flow cassette, 25 tests
Sample type: Fingerstick whole blood, venous whole blood, serum or plasma
Sample volume: 2.5µl
Sensitivity: 99.8%
Specificity: 99.9%
Time to result: 15 mins

Manufacturer product reference: Chembio Diagnostic Systems, HIV201.

Items supplied with:
1. - 25 Pouches, with each pouch containing 1 test strip, 1 buffer vial attached to the sampler (~350 μl), 1 sterile lancet, 1 bandage, and 1 desiccant packet
2. - 2. Disposable Rack for holding Buffer Vials upright, 1
3. - Insert for the Disposable Rack, 1
4. - Instructions for use, 1

Items required, but not supplied:
Plain/dry vacuum tube (for serum samples), EDTA vacuum tube (for plasma samples), pipettor capable of delivering 2.5μL of sample, Disposable gloves, sterile gauze, anti-septic swabs, container for biohazard disposables, clock, watch.

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

Storage and transportation:
Between 8- 0°C, protected against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of Sure Check HIV 1/2 for 25 tests
Secondary packaging: One kit Sure Check HIV 1/2, 25 tests

Weight and volume:
Estimated weight: 0.5Kg
Estimated volume: 3.53dm³

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_l ist/en/