global point of care
Uit prestatiebeoordelingen van de WHO blijkt dat de analytische gevoeligheid van de meeste sneltesten tussen de 2 en 10 IU/mL ligt.2 Er is geen sneltest voor gebruik in plasma, serum en volbloed bekend die voldoet aan de door de EU en WHO vastgestelde minimale vereisten voor analytische gevoeligheid van 0,13 IU/mL.3 Tot nu toe.
De Determine™ HBsAg 2, met een analytische gevoeligheid van slechts 0,1 IU/mL, is een uiterst gevoelige, gebruiksvriendelijke sneltest waarmee via laterale flow snel en nauwkeurig kan worden vastgesteld of een patiënt HBsAg-positief is. Op deze manier kunnen meer gevallen van HBV worden opgespoord en patiënten sneller worden gekoppeld aan de juiste zorg en behandeling in een breed scala van gezondheidszorginstellingen.
Product niet in alle landen beschikbaar. Niet goedgekeurd voor verkoop in de Verenigde Staten.
Analytische gevoeligheid van 0,1 IU/mL
| Determine™ HBsAg 2 | Code |
|---|---|
| Determine HBsAg 2 (CE) 20 Tests | 7D2946 |
| Determine HBsAg 2 (CE) 100 Tests | 7D2947 |
| Determine HBsAg 2 SET 100 Tests | 7D2943 SET |
| Chase Buffer (2,5 mL, 100 tests) | 7D2243 |
| EDTA-capillairen (CE) 100 tests | 7D2227 |
| EDTA-capillairen (niet-CE) 100 tests | 7D2222 |
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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