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Determine HBsAg 2

用於檢測血清、血漿或全血 B 型肝炎表面抗原的全球最靈敏快速診斷檢測法。1,2,3

分析靈敏度 > 1 IU/mL,可降低對於無症狀 HBV 感染的檢測法能力需求。4 世界衛生組織性能評估表明,大多數快速檢測法的分析靈敏度範圍為 2-10 IU/mL。2 在此之前,沒有任何血漿、血清及全血的快速檢測法被報告符合歐盟和世界衛生組織要求的最低分析靈敏度 0.13 IU/mL。3

Determine™ HBsAg 2 的分析靈敏度僅為 0.1 IU/mL,是一種高靈敏度、易於使用的快速側流式檢測法,能夠快速、準確地識別 HBsAg 陽性患者,發現更多的 HBV 病例,並能幫助患者在任何醫療環境中快速地獲得適當照護。

僅在選定的市場出售。尚未獲准在美國銷售。

檢視參考資料

  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: http://www.who.int/diagnostics_laboratory/evaluations/hepb/161125_who_performance_criteria_hbsag_ivd.pdf?ua=1. 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.
  4. Khuroo et al, Accuracy of Rapid Point-of-Care Diagnostic Tests for Hepatitis B Surface Antigen--A Systematic Review and Meta-analysis J Clin Exp Hepatology 2014.

   

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