| 中文摘要 |
用於製造血液製劑之混合血漿（Plasma pool）將被要求應以核酸擴增技術（Nucleic acid amplification techniques, NAT）檢測parvovirus B19 DNA 且需低於規定含量，為因應該項政策之實施，本局業已建立Parvovirus B19 核酸國家標準品與工作標準品，將可供B19 NAT 分析方法品質控管與定量參考物質之用。為使該標準品具客觀性與公信力，包括本局實驗室在內，國內外總計有來自7 個國家10 個相關機構參與共同標定研究，以WHO B19 核酸國際標準品標定我國國家標準品，參與機構以該實驗室例行使用之NAT方法分析B19 候選標準品與WHO 國際標準品，各機構均進行三次獨立試驗標定候選標準品含量，統計分析結果顯示參與實驗室間之標定數據一致性極佳，遂訂定此國家標準品含量為1.9 × 106 IU/mL，工作標準品含量為2 × 104 IU/mL。安定性評估研究結果顯示該二項標準品於25°C 4 週, 4°C 8 週,-20°C 及-80°C 至少18 個月的條件下均相當穩定。" |
| 英文摘要 |
Mandatory requirements for plasma pools containing a maximum concentration of human parvovirus B19 DNA will be established in Taiwan in the near future. To facilitate the implementation of the policy, a National Standard and working reagent were established for human parvovirus B19 DNA nucleic acid amplification techniques (NAT). The standards are intended to be used for the quality control of B19 NAT assays and as a quantitative reference material for B19 NAT testing. A collaborative study, including 10 laboratories from seven countries, was done in order to establish the National Standard and working reagent for B19 DNA NAT assays by calibration, in International Units (IU), against the WHO International Standard for B19 (99 /800). Participants were requested to test the candidate materials and the WHO International Standard by the NAT assay in routine use in the laboratory. The mean B19 DNA content of the standards was determined by each laboratory in three independent assays and the results were analyzed statistically. Overall, a high level of agreement among results was achieved from different laboratories. Consequently, the first National Standard and working reagent for B19 DNA NAT assays with an assigned value of 1.9 × 106 IU/mL and 2.0 × 104 IU/ mL, respectively, were established. The results of the stability analysis indicated that both reagents were stable for 4 weeks at 25°C, for 8 weeks at 4°C, for at least 18 months at -20°C or -80°C. |
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