Determine HBsAg 2 w/o accessories,kit/20

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, 20 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, 7D2942

Items supplied with:
•Determine HBsAg 2 test cards, 2 cards of 10 tests/card
•IFU, 1

Items required, but not supplied:
•For testing Whole Blood Samples: Chase Buffer (7D2243) 1 Bottle (2.5 mL) containing phosphate buffered saline, preservative and antimicrobial agent
•For testing Whole Blood Samples (fingerstick assay): Single use sterile lancet and EDTA capillary tube (7D2222)
•New pair of disposable gloves, timer, micropipette capable of delivering 50μl, alcohol swabs

Shelf life:
18 months from the date of manufacturing.

Weight & volume:
Estimated weight: 0.072kg
Estimated volume: 0.00036m3

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 without accessories for 20 tests
Secondary packaging: One kit Determine HBsAg 2 without accessories, 20 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/