OraQuick HIV1/2,kit/100

General description:
OraQuick HIV-1/2 Rapid Antibody Test is a qualitative, in vitro immunoassay. It detects antibodies to the human immunodeficiency virus types 1 and 2 (HIV-1/2) in human oral fluid, whole blood, serum or plasma (EDTA).

Intended use:
It is intended for use in a near patient care setting by trained health care workers
.

Technical specifications:
·Technology: Rapid immunochromatographic assay.
·Format: Lateral flow cassette, 100 tests.
·Sample type: Serum, plasma (EDTA), venous whole blood (EDTA, Sodium heparin and sodium citrate), capillary whole blood, oral fluid.
·Number of steps: 2 without precision required.
·Sample volume: 70µl (oral fluid); 5µl (others)
·Sensitivity:
Plasma/Serum specimen: 99.1%
Oral fluid specimen: 99.1%
·Specificity:
Plasma/Serum specimen: 99.8%
Oral fluid specimen: 100%
·Invalid rate plasma/serum: 0.1%
·Invalid rate oral specimen: 0%
·Time to result: 20 mins

Manufacturer product reference:
Orasure Technologies, 5X4-0010

QMS/Regulatory information:
·ROW (Rest-of-World)
·ISO 13845:2016
·WHO Pre-Qualified product

Kit content:
·100 x Test device pouch containing: 1 test device, 1 desiccant and 1 developer solution (1.0ml) vial
·10 x Test stands
·5 x Specimen collection loops (5ul)
·1 x IFU

Items required, but not supplied:
·Consumables, for testing on fingerstick whole blood specimen: Alcohol swabs and Sterile Lancet
·Equipment: Timer and Watch

Accessories:
OraQuick ADVANCE Rapid HIV-1/2 Antibody Test Kit Controls (Product code: 1001-0077)
(Vial 1 - 1x HIV-1 positive control; Vial 2 - 1x HIV-2 positive control; and Vial 3 - 1x Negative control. Sufficient to run approximately 25 tests.)
Unopened expiry date: 12-months.

Loop:
Package of 5 (Product code: 1001-0144)
Package of 25 (Product code: 1001-0145)

Test Stand:
Package of 5 (Product code: 004-0002)

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

Storage and transportation:
Between 2 to 30°C, protected against humidity and direct sunlight. Do not freeze reagents.
Note: This test should be performed at temperatures in the range of (15 to 37 °C).
If stored in a refrigerator, ensure that the Divided Pouch is brought to operating temperature (15 to 37 °C) before performing testing.

Packaging and labelling:
Primary packaging: All contents of OraQuick HIV 1/2 for 100 tests.
Secondary packaging: One kit OraQuick HIV 1/2, 100 tests.

Weight and volume:
Estimated weight: 2.4 Kg
Estimated volume: 0.03 m3

General recommendations:
Public reports of WHO prequalified in vitro diagnostic products can be found here:
Follow strictly manufacturer instructions for use of the test procedure (especially adherence to reading time).