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題 名 | 新上市流感快篩試劑之檢測效能評估=Performance Evaluation of a Novel Rapid Influenza Test |
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作 者 | 楊季融; 郭權益; 林昭樺; 吳和生; 劉銘燦; | 書刊名 | 疫情報導 |
卷 期 | 30:22 2014.11.25[民103.11.25] |
頁 次 | 頁443-450 |
分類號 | 412.4 |
關鍵詞 | 流感病毒; 流感快篩試劑; Influenza virus; Rapid test; Sofia FIA; |
語 文 | 中文(Chinese) |
中文摘要 | 流行性感冒 (Influenza) 病毒為全世界重要之呼吸道病原體,每年皆可引起人類嚴重感染及死亡。早期診斷是防治流感疫情的重要利器,早期使用克流感等抗病毒藥物亦可大幅提升患者治療效果。由於流感病毒活躍時,國內各級醫院及各地區診所往往為診斷患者的第一線場所,為協助臨床醫師於診間快速檢測流感病毒,以達早期用藥之效,並探討此種快篩試劑對疾病管制署(簡稱疾管署)防疫業務的實質幫助,本研究以 73件臨床檢體,針對目前新上市流感快篩試劑 Sofia FIA之檢測靈敏度及特異性進行評估,並與real-time RT-PCR的檢驗結果比較。評估結果顯示,與 real-timeRT-PCR相比,Sofia快篩試劑對 A型流感的整體檢測靈敏度為 68.2%;對 B型流感則為 45.5%。當檢體為 A型流感陽性且 real-time RT-PCR之檢測 Cp值小於 30時,Sofia FIA的檢測靈敏度可達 85%以上 (對 H1N1pdm09病毒為 92%;對 H3N2病毒為 85%);B型流感陽性且Cp值小於30時,Sofia檢測靈敏度則為69%。特異性評估結果則為100%,並無偽陽性現象產生。綜合上述發現,Sofia FIA快篩試劑對於 A型流感的檢測能力較 B型流感為高,且表現較傳統型流感快篩試劑佳。此種新式流感快篩試劑應可有效幫助不具專業流感檢測實驗室之醫療機構進行患者初步檢測;同時可協助疾管署於機場或港口的邊境檢疫業務,防堵新型流感(如 H5N1或 H7N9等)藉由境外移入方式侵襲我國。 |
英文摘要 | Influenza is an annually occurred infectious disease, causing severe infection and death among humans. Rapid influenza diagnostic tests (RIDTs) can facilitate appropriate prescription of antivirals for influenza treatment, reduce the need for unnecessary testing and allow the implementation of infection control measures. In this study, a novel Sofia influenza A+B fluorescent immunoassay (FIA) was evaluated for its detection ability for both influenza A and B viruses and compare with real-time RT-PCR assay. A total of 73 throat swab specimens were tested; the results showed that Sofia FIA exhibits detection sensitivity of 68.2% and 45.5% for influenza A and B viruses, respectively, comparing with real-time RT-PCR. If Cp (cycle of crossing point) value of real-time RT-PCR was set lower than 30, the sensitivity for influenza A and B viruses reached to 85% and 69% by Sofia kit. Moreover, the evaluated specificity of Sofia FIA was 100%. These results indicate that this novel RIDT has greater detection ability toward influenza A than influenza B viruses and the entire performance is better than traditional RIDTs, highlighting the future applications for clinical diagnosis and control of influenza. |
本系統中英文摘要資訊取自各篇刊載內容。