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.
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.
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.
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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