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Africa

GLOBAL POINT OF CARE

Determine™ HBsAg 2

The world's most sensitive rapid diagnostic test for detection of hepatitis B surface antigen for use with serum, plasma or whole blood.1,2,3

WHO performance evaluations show that the analytical sensitivity of most rapid tests ranges from 2-10 IU/mL2 No rapid test for use with plasma, serum and whole blood has been reported to meet the minimum EU and WHO requirements of analytical sensitivity of 0.13 IU/mL,3 until now.

Determine™ HBsAg 2, with an analytical sensitivity of just 0.1 IU/mL, is a highly sensitive, easy to use rapid lateral flow test that enables quick, accurate identification of HBsAg positive patients, increasing HBV case finding and facilitating fast and appropriate linkage to care in a wide variety of healthcare settings.

Product not available in all countries. Not approved for sale in the USA.

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Determine™ HBsAg 2 Determine™ HBsAg 2 Determine™ HBsAg 2
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Benefits
  • Increase case finding
  • Detecting infection earlier leads to better patient outcomes
  • Rapid turnaround time helps reduce patients lost to follow up
  • Simple procedure with no special expertise or lab equipment required
  • Flexibility of multiple sample types
  • Detects major HBsAg mutants (refer to Product Insert)
  • Ideal for use in a wide variety of healthcare settings

Analytical sensitivity
of 0.1 IU/mL

Helpful Documents

PRODUCT DOCUMENTS

SPECIFICATIONS

  • Analytical sensitivity: 0.1 IU/mL
  • Specificity: 99.6%
  • Sample volume: 50µl
  • Time to result: 15 min
  • Sample types: Serum/Plasma, Fingerstick Whole Blood, Venipuncture Whole Blood
  • Detect major vaccine escape mutants (refer to Product Insert)
  • Shelf life: 18 months
  • Storage conditions: 2-30°C
  • 20 tests or 100 tests format

PRODUCT CODE

Determine™ HBsAg 2Code

Determine HBsAg 2 (CE) 20 Tests

7D2946
Determine HBsAg 2 (CE) 100 Tests7D2947
Determine HBsAg 2 (Non-CE) 20 Tests7D2942
Determine HBsAg 2 (Non-CE) 100 Tests7D2943
Determine HBsAg 2 SET 100 Tests7D2943 SET
Chase Buffer (2.5 mL, 100 Tests)7D2243
EDTA Capillaries (CE) 100 Tests7D2227
EDTA Capillaries (Non-CE) 100 Tests7D2222
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View References

  1. Downing RG., Forssten C., Kabbale P., Newton R., Robins T., Tamanoue Y. (2019, February). Determine™ HBsAg 2: A novel rapid test for the detection of hepatitis B virus infection. Poster session presented at: 28th Conference of Asian Pacific Association for the Study of the Liver; 2019 February 20-24; Manila, Philippines; based on package inserts or other company-produced material in public domain.

  2. World Health Organisation. WHO performance evaluation acceptance criteria for HBsAg In vitro diagnostics in the context of WHO prequalification. Available at: <a adhocenable="false" Accessed 29 January 2019.

  3. Amini A, Varsaneux O, Kelly H et al. Diagnostic accuracy of tests to detect hepatitis B surface antigen: a systematic review of the literature and meta-analysis. BMC Infect Dis 2017; 17(Suppl 1):698-716.

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