C型肝炎病毒抗體快篩試劑的運用

Rapid diagnostic tests for detection of antibodies to hepatitis C virus

楊雯雯(Wen-Wen Yang) ； 吳慧敏(Grace Hui-Min Wu) ； 劉嘉玲(Chia-Ling Liu) ； 鄭國本(Kuo-Pen Cheng) ； 余明隆(Ming-Lung Yu) ； 蒲若芳(Raoh-Fang Pwu) ； 盧勝男(Sheng-Nan Lu) ； 簡榮南(Rong-Nan Chien)

《台灣公共衛生雜誌》 42卷6期 (2023/12) Pp. 594-611

https://doi.org/10.6288/TJPH.202312_42(6).112031

摘要

慢性C型肝炎病人可能在沒有症狀或是沒有特異性症狀的狀態下持續數十年，等到症狀出現，病情往往已惡化到威脅生命的肝硬化或是肝癌階段。及早發現C型肝炎病毒（HCV）感染，對於防治後續併發症是十分重要的。傳統先經實驗室檢驗C肝抗體（anti-HCV）陽性，再以核酸檢驗來確認C肝病毒是否存在的兩階段檢定步驟，被認為是發掘及診斷HCV病毒感染的關鍵挑戰。除了傳統實驗室的血清抗體檢驗外，世界衛生組織亦建議以快篩試劑作為anti-HCV檢驗分析方法之一，並認為快篩將可改善篩檢到後續照護與治療的連結。2020年以來，C肝抗體快篩試劑的敏感度及特異度已有提升；目前我國已有3項C肝抗體快篩試劑取得上市許可證，依據文獻回顧結果，其敏感度及特異度分別至少都在92.8%及92.6%以上。本文蒐集文獻並彙整C肝抗體快篩試劑的檢驗效能和國際運用情境文獻，希望有助於提升國人對C肝快篩檢試劑的認識，並討論其在台灣推動C肝消除的可能應用。

關鍵字

C肝篩檢 ； C肝抗體快篩試劑 ； 快篩 ； 敏感度 ； 特異度

並列摘要

Most patients with chronic hepatitis C often remain asymptomatic or experience nonspecific symptoms for decades, and by the time symptoms manifest, the disease has deteriorated to life-threatening stages such as cirrhosis or liver cancer. Early detection of hepatitis C virus (HCV) infection is crucial for preventing and managing subsequent complications. The conventional two-step diagnostic process, involving initial enzyme immunoassay testing for HCV antibodies (anti- HCV) followed by nucleic acid testing in the laboratory to confirm the presence of HCV, presents a significant challenge in the discovery and diagnosis of HCV virus infection. In addition to traditional laboratory-based serum antibody testing, the World Health Organization recommends the use of rapid diagnostic tests (RDTs) as one of the methods for analyzing anti-HCV antibodies, with the potential to improve access and linkage to care and treatment. Since 2020, the studies have shown that both the specificity and sensitivity of the anti-HCV RDTs have been improved. Three anti-HCV RDTs in Taiwan have received market approval, each demonstrating a sensitivity and specificity of at least 92.8% and 92.6%, respectively, as indicated by literature reviews. This article collects and summarizes existing literature on the diagnostic performance of anti-HCV RDTs and their implementation scenarios. It aims to enhance awareness across various sectors regarding the utility of anti-HCV RDTs and to discuss their potential applications in accelerating hepatitis C elimination efforts in Taiwan.

並列關鍵字

hepatitis C screening ； anti-HCV rapid diagnostic test ； RDT ； sensitivity ； specificity

參考文獻

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