Determine HBsAg2 withaccessories,kit/100

General description:
Determine HBsAg 2 is an in vitro, immunochromatographic test for the qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human capillary and venous whole blood, plasma or serum. The test is intended as an aid in the diagnosis of HBV infection through detection of HBsAg from infected individuals. The test is for professional use only.

Technical specifications:
Technology: Rapid immunochromatographic assay
Format: Lateral flow cassette, 100 tests
Sample type: Whole blood, serum, plasma
Sample volume: 50µl
Sensitivity: 100%
Specificity: 100%
Invalid rate: 0.12%
Time to result: 15 minutes, read the result within a maximum of 30 minutes

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

Items supplied with:
·Determine HBsAg 2 test cards, 10 cards of 10 tests/card
·Chase buffer (2.5ml), 1 bottle
·EDTA capillary tube, 1 pack for 100 tests
·Sterile lancets, 1 box for 100 tests
·IFU, 1

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: 0.330kg
Estimated volume: 0.0021m3

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:
WHO list of prequalified in vitro diagnostic products for Hepatitis B:
https://www.who.int/diagnostics_labor atory/evaluations/pq-list/hbsag/public_report/en/