GLOBAL POINT OF CARE
GLOBAL POINT OF CARE
Les évaluations de performance de l'OMS montrent que la sensibilité analytique de la plupart des tests rapides varie de 2 à 10 UI/ml.2 Aucun test rapide qui utilise comme échantillon du plasma, du sérum et du sang total ne s'est avéré répondre aux exigences minimales de l'UE et de l'OMS qui requièrent une sensibilité analytique de 0,13 UI/ml.3 Jusqu’à maintenant.
Grâce à une sensibilité analytique de seulement 0,1 UI/ml, Determine™ HBsAg 2 est un test rapide à migration latérale, très sensible et facile à utiliser. Il permet une identification rapide et précise des patients positifs à l'AgHBs, augmentant ainsi le dépistage des cas de VHB pour une prise en charge thérapeutique rapide et adaptée dans de nombreux contextes médicaux.
*Ce produit n’est pas disponible dans tous les pays. Vente non autorisée aux États-Unis.
Sensibilité analytique de 0,1 UI/ml
| Determine™ HBsAg 2 | Code |
|---|---|
| Determine HBsAg 2 (CE) 20 tests | 7D2946 |
| Determine HBsAg 2 (CE) 100 tests | 7D2947 |
| Determine HBsAg 2 (Non-CE) 20 tests | 7D2942 |
| Determine HBsAg 2 (Non-CE) 100 tests | 7D2943 |
| Determine HBsAg 2 SET 100 tests | 7D2943SET |
| Chase Buffer (2,5 ml, 100 tests) | 7D2243 |
| Tubes capillaires EDTA (CE) 100 tests | 7D2227 |
| Tubes capillaires EDTA (hors 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: http://www.who.int/diagnostics_laboratory/evaluations/hepb/161125_who_performance_criteria_hbsag_ivd.pdf?ua=1. 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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