Determine HBsAg2 withaccessories,kit/100

General Description
Determine HBsAg 2 is an in vitro, visually read, qualitative immunoassay for the detection of Hepatitis B Surface Antigen (HBsAg) in human capillary and venous whole blood, plasma or serum.

Intended Use:
The test is intended as an aid in the diagnosis of HBV infection through detection of HBsAg from infected individuals. The test is not intended for screening blood donors. The test is for professional use only.

Technical specifications:
Technology: Rapid immunochromatographic assay.
Number of steps: 1 with precision (serum/plasma) or 2 with/without precision (venous/capillary whole blood).
Format: Lateral flow test cards.
Sample type: Venous and capillary whole blood, serum, plasma (EDTA).
Sample volume: 50µl.
Sensitivity: 100%.
Specificity: 100%.
In-use stability of reagents: The test should be used within 2 hours after removing the protective foil cover from the test strip.
Time to result: 15 minutes. (Read the result within a maximum of 30 minutes.)

Manufacturer product reference: Abbott Diagnostics Medical Co.,
Ltd, 7D2943SET.

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

Items supplied with:
·10 Determine HBsAg test cards, 10 tests/card.
·1 x Chase buffer bottle (2.5ml)
·100 x EDTA capillary tubes - Jiangsu Kehua Medical Instrument, China ,
·100 x Sterile non-safety lancets - CE Marked, Tianjin Huahong Technology Co. China
·1 x IFU.

Items required, but not supplied:
New pair of disposable gloves, timer, micropipette capable of delivering 50μl, alcohol swabs, gauze pad

Shelf life:
18 months from the date of manufacturing.

Weight & volume:
Estimated weight: 0.33kg.
Estimated volume: 16.2 x 6.1 x 21.3 cm.

Storage & transportation condition:
The test kit should be stored at 2 - 30°C, protect against humidity and direct sunlight.

Packaging and labeling:
Primary packaging: All contents of Determine HBsAg 2 with accessories for 100 tests.
Secondary packaging: One kit Determine HBsAg 2 with accessories, 100 tests.

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