STANDARD Q HIV1/2Ab 3-Linew/oacc,kit/25

General Description:
STANDARD™ Q HIV 1/2 Ab 3-Line Test is a rapid chromatographicimmunoassay for the qualitative detection of antibodies specific toHIV-1 including subtype O and HIV 2 in human serum, plasma or venous andcapillary whole blood. The test is for in vitro diagnostic use andintended as an aid to diagnosis of HIV in symptomatic, asymptomaticpopulations and persons at risk of HIV infection. The test is notintended for use on neonates or infants below 2 years. To be used bytrained healthcare or laboratory professionals or other health careworkers who have received appropriate training and can be used bytrained lay providers operating in point-of-care settings.

Technical specifications:
Technology: Rapid chromatographic immunoassay.
Format: Test cassette, 25 tests.
Sample type: Serum, plasma or venous and capillary whole blood.
Sample volume: Serum, Plasma 10µl/whole Blood 20 µl.
Sensitivity: Plasma (99.78&) Serum (99.4&), Whole Blood (100) &Capillary whole Blood (100).
Specificity: Plasma 100. Serum (99.92%) & venous whole blood (100%)
Time to result: Minimum of 10 minutes.

Manufacturer product reference: SD Biosensor, 09HIV30DM

Kit content:
·1x 25 test device individually in a foil pouch with desiccant.
·1×1 Buffer Bottle, 4 ml.
·1×1 IFU.

Items required, but not supplied:
General Lab equipment’s:
·Anti-coagulant tube containing heparin, EDTA or sodium citrate.
·Micropipette and tip.
·Sterile lancet.
·Sterile swab.
·PPE (Personal Protective Equipment).
·Biohazard container.
·Capillary whole blood collection tool.

Shelf life:
24 months.

Storage and transportation:
Store the kit unopened at 2-40°C/36-104°F, out of direct sunlight.

Packaging and labeling:
Primary packaging: STANDARD Q HIV 1/2 Ab 3-Line Test for 25 tests.
Secondary packaging: One kit STANDARD Q HIV 1/2 Ab 3-Line Kit/25T.

Weight and volume:
Estimated weight: 0.245 Kg.
Estimated volume: 1.45 dm3.

General recommendations:
1.Carefully read the instruction for using the STANDARD Q HIV 1/2 Ab3-Line Test.
2.Check the expiry date at the back of the foil pouch. Use anotherlot, if expiry date has passed.
Open the foil pouch and check the test device and the colour indicatordesiccant pack in foil pouch

Useful links:
WHO list of prequalified in vitrodiagnostic products: