Oraquick HIV self-test, Kit/50

General Description:
The OraQuick® HIV Self-Test is an in-vitro diagnostic medical device (IVD) that is used for self-testing of antibodies for HIV-1 and HIV-2 in oral fluid. This test is intended as an aid to detect antibodies to HIV-1 and HIV-2 from infected individuals.

Technical specifications:
Sensitivity: 100%
Specificity: 99.1%
Time to result: 2 0 mins and not after 40 mins
Specimen type: Oral fluid

Manufacture product reference code: OraSure Technologies Inc., 5X4-1000

Supplied with:
50 pouched kits: Each pouched kit contains:
•1 divided pouch with - a single use test device; and - a desiccant; and - a developer solution vial containing 1ml of phosphate buffer saline solution containing polymers and an antimicrobial agent
•1 test stand
•1 instructions for use
•1 disposal bag

Items required but not provided:
Clock, watch, or timing device

Shelf Life:
30 months from the date of manufacturing.

Weight and Volume:
Estimated weight: 2.00 Kg
Estimated volume: 0.030 m³

Storage condition:
Between 2 to 30 °C. Protect against humidity and direct sunlight. Do not freeze reagents.

Packaging and labeling:
Primary packaging: All contents of Oraquick HIV self-test for 50 tests

Secondary packaging: One kit Oraquick HIV self-test, 50 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:
https://extranet.who.int/pqweb/vitro-diagnos tics/prequalification-reports/whopr