C型肝炎抗體對照血清組之製備

Preparation of Reference Panels for Anti-HCV Diagnostic Kits

杜慧珍(Huey-Jen Duh) ； 傳淑卿(Shu-Ching Fu) ； 紀長文(Chang-Wen Chi) ； 柳逸照(Yi-Chao Liu) ； 賴秀芸(Show-Yun Lai) ； 楊若英(Ruoh-Ing Yang) ； 陳作琳(Tso-Ling Chen) ； 林嘉伯(Chia-Po Lin)

《藥物食品檢驗局調查研究年報》 24號 (2006/12) Pp. 110-120

https://doi.org/10.6946/ASRNL.200612.0110

摘要

C型肝炎病毒(Hepatitis C virus, HCV)主要經由直接接觸該病毒污染之血液傳染，至今尚未有C型肝炎疫苗問世，因此加強確保血源與血液製劑產品之病毒安全性，實為主要有效控制C型肝炎病毒感染方式之一。本局參照世界衛生組織之指導方針及相關文獻所載之製備方法，以自中華血液基金會取得正常及C型肝炎抗體陽性之血源，研製可供國內各體外診斷試劑製造廠，進行C型肝炎抗體體外診斷試劑效能品質評估及管控使用之對照血清組。總計完成150組對照血清組(Reference panel)，每組包含陽性與陰性反應血清共12支。
本研究邀集所有於國內領有C型肝炎抗體體外診斷試劑許可證之製造廠或輸入代理商參與此對照血清組之共同標定試驗，以制定該對照血清組之檢驗規格；另由本局進行該血清組之即時安定性試驗以評估其儲存安定性。依據共同標定試驗結果制可該對照血清組之檢驗規格，分別為5支C型肝炎抗體陽性反應血清，3支可能檢測為陽性反應血清及4支陰性反應血清；即時安定性試驗結果顯示該對照血清組於-80±5℃與-20±5℃安定性至少達一年，5±3℃安定性至少達六個月，23±2℃安定性至少達四週，故此對照血清組具良好的安定性。

關鍵字

C型肝炎病毒 ； C型肝炎病毒抗體 ； 對照血清組 ； 即時安定性試驗

並列摘要

The main infection route of Hepatitis C virus (HCV) is through blood contamination. Since Hepatitis C vaccine is currently unavailable, the most effective way to prevent infection is to confirm the viral safety of blood source material and blood products. In 2003, we produced 150 sets of anti-HCV reference panel (Lot No.9201) based on WHO's guideline and other references. Each set of reference panel (containing 12 members with anti-HCV positive and negative) was provided for diagnostic kits manufacturers to do the performance test for their products.
To establish the specification and evaluate stability of the anti-HCV reference panel, we invited domestic and foreign manufacturers of anti-HCV diagnostic kits to make a co-laboratory study. The anti-HCV reference panel was defined as 5 anti-HCV positive, 4 anti-HCV negative, and 3 border line sera. The result of real time stability evaluation showed that the panel was stable for at least 9 months at -20~-80℃, 6 months at 4℃, and one month at 25℃. The stability evaluation at -80℃ and -20℃ is still ongoing for determing the shelf life of the reference panels.

並列關鍵字

Hepatitis C virus ； Anti-HCV ； Reference panel ； Real time stability evaluation