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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

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，並能幫助患者在各種醫療環境中快速地獲得適當照護。

產品僅在部分國家/地區提供。尚未獲准在美國銷售。

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助益
  • 發現更多的病例
  • 早期檢測出感染病例，改善患者的治療效果
  • 較短的檢測週期，有助於減少患者失訪
  • 操作簡單，無需特殊的專業知識或實驗室設備
  • 多種樣本類型，較好的靈活性
  • 檢測主要的 HBsAg 突變體（參見產品說明書）
  • 適合各種醫療環境下使用

分析靈敏度為 0.1 IU/mL

詳細資訊

說明文件

產品規格

  • 分析靈敏度︰0.1 IU/mL
  • 特異性：99.6%
  • 樣本量：50µl
  • 讀取時間：15-30 分鐘
  • 樣本類型：血清/血漿、指尖全血、靜脈穿刺全血
  • 檢測主要的疫苗逃逸突變體（參見產品說明書）
  • 保存期：18 個月
  • 儲存條件：2-30°C
  • 20 次檢測或 100 次檢測設計

 

品項

Determine™ HBsAg 2
代碼
Determine HBsAg 2 (CE) 20 次檢測7D2946
Determine HBsAg 2 (CE) 100 次檢測7D2947
Determine HBsAg 2（非 CE 認證）20 次檢測7D2942
Determine HBsAg 2（非 CE 認證）100 次檢測7D2943
Determine HBsAg 2 套件 100 次檢測7D2943 套件
Chase Buffer（2.5 mL、100 次檢測）7D2243
EDTA 毛細管 (CE) 100 次檢測7D2227
EDTA 毛細管（非 CE）100 次檢測7D2222
相關產品

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.

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