INFECTIOUS DISEASES

FACT SHEET

DETERMINE HBsAg 2 ™

PRODUCT DESCRIPTION SPECIMEN TYPE STORAGE CONDITIONS

Determine™ HBsAg 2 is an In Vitro, visually Human serum, plasma or whole blood • Storage temperature : 2-30 ˚C
read, qualitative immunoassay for the • Store serum and plasma specimens at
detection of Hepatitis B Surface Antigen PERFORMANCE 2-8 °C and run the test within 7 days of
(HBsAg) in human serum, plasma or whole • Analytical sensitivity of 0.1 IU/mL collection. If testing is delayed more than 7
blood. The test is intended as an aid to detect or 0.19 ng/mL (French ng). days, the specimens should be frozen (-20
HBsAg from infected individuals. The test is • Specificity : 99.6 % °C or colder).
professional use only. • Avoid repeated freeze/thaw cycles.
* Sensitivity and Specificity are extracted
• For whole blood collected by venipuncture,
from the Instructions for use.
PRODUCT CODES store at 2-8 °C. Do not freeze whole blood
• 7D2946: Determine™ HBsAg 2 (20 Tests, CE) specimens. Run the test within 2 days (48
RUNNING TIME FOR TEST RESULT hours) of collection.
• 7D2947: Determine™ HBsAg 2 (100 Tests, CE)
• 7D2942: Determine™ HBsAg 2 (20 Tests, INTERPRETATION • For whole blood collected by fingerstick,
Non-CE) 15-30 minutes test immediately.
• 7D2943: Determine™ HBsAg 2 (100 Tests,
Non-CE) QUALITY CONTROL SHELF LIFE
• 7D2943SET: Determine™ HBsAg 2 SET To ensure assay validity, a procedural control 18 months
(Non-CE) Includes 100 Tests, Chase Buffer, system is incorporated in the device. A red
100 EDTA Capillaries, 100 Sterilized Blood control bar will appear in the window. If
Lancets the control bar does not appear by assay
• 7D2243: Chase Buffer (2.5 mL, 100 Tests) completion, the test result is invalid. Repeat
• 7D2227: EDTA Capillaries (100 Tests, CE) the test using a new test strip.
• 7D2222: EDTA Capillaries (100 Tests, Non-CE)
PACKING INFORMATION
KIT CONTENTS 100 tests per kit (pouch)
Determine™ HBsAg 2 Test Cards: • Dimensions: (length x width x height) 272 x
2 or 10 cards (containing 10 tests/card), 160 x 20 mm
sufficient to perform 20 tests or 100 tests • Volume: 800 cm3
• Weight: 150 g
ACCESSORIES 20 tests per kit (pouch)
For testing Whole Blood Samples: • Dimensions: (length x width x height) 272
• Chase Buffer 1 Bottle (2.5 mL) containing x 160 x 9 mm
phosphate buffered saline, preservative and • Volume: 360 cm3
antimicrobial agent. • Weight: 66 g
For testing Whole Blood Samples
(fingerstick assay): SHIPPING CARTON
• Lancet 100 tests per kit, 50 kits per carton
• EDTA capillary tube • Dimensions: 460 x 340 x 270 mm
• Volume: 42,228 cm3
Materials Required But Not Provided: • Weight: 8,800 g
• Disposable gloves
• Timing device 20 tests per kit, 90 kits per carton
• Micropipette capable of delivering 50 μL • Dimensions: 460 x 340 x 270 mm
(not required for fingerstick method) • Volume: 42,228 cm3
• Alcohol swab, gauze pad • Weight: 7,280 g

Alere Medical Co., Ltd.

357 Matsuhidai, Matsudo-shi, Chiba, 270-2214 Japan
Tel +81 47 311 5750 | abbott.com/poct

© 2019 Abbott. All rights reserved. Determine is a trademark of the Abbott group of companies. All trademarks referenced are trademarks of their respective owners.
120005009-02, 03/19