Bioline HBsAg WB w/o accessories,kit/30

General description:
Bioline HBsAg WB is an in vitro immunochromatographic, rapid assay designed for the qualitative detection of Hepatitis B surface antigen, in human serum, plasma (heparin, EDTA and sodium citrate) or venous whole blood (heparin, EDTA and sodium citrate).

Intended use:
Bioline HBsAg WB is intended only for professional use as an aid to diagnosis. Reactive specimens should be reflexed for additional testing, either by Enzyme immunoassay (EIA) to identify current HBV infection. This test may not be suitable for diagnosis of early infection or blood donation screening. The performance of Bioline HBsAg WB in infants or children has not been validated.

Technical specifications:
Technology: Lateral immuno-chromatographic test.
Format: Cassette, 30 tests.
Sample type: Venous whole blood, plasma, serum.
Sample volume: 100µl.
Number of steps: 1 with precision required
Sensitivite:100%.
Specificity: 99%.
Invalid rate: 0.2%.
Reading time: 20 mins.

Manufacturer product reference:
Abbott Diagnostics Korea Inc., 01FK10W.

Items supplied with:
·30 x Test device pouch containing: 1 test device, 1 desiccant.
·1 x IFU

Items required, but not supplied:
Blood sample collection devices, Disposable gloves, timer, container for biohazard disposables, micropipette.

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

Weight & volume:
Estimated weight: 0.2kg.
Estimated volume: 18.2 x 12.5 x 7.1 cm3.

Storage & transportation condition:
The test kit should be stored at 1°C to 40°C, protect against humidity and direct sunlight. Do not freeze reagents.

Packaging & labelling:
Primary packaging: All contents of Bioline HBsAg WB without accessories, kit for 30 tests
Secondary packaging: One kit Bioline HBsAg WB without accessories, 30 tests

Useful links:
Public reports of WHO prequalified in vitro diagnostic products.