A型流行性感冒病毒快速診斷試劑效能評估調查研究

Post-Market Surveillance for the Performance of Influenza a Rapid Test in Vitro Diagnostic Devices

林佳蓓(Chia-Pei Lin) ； 高明輝(Ming-Hui Kao) ； 方怡雅(Yi-Ya Fang) ； 王德原(Der-Yuan Wang) ； 羅吉方(Chi-Fang Lo)

《食品藥物研究年報》 2期 (2011/12) Pp. 281-287

https://doi.org/10.6945/ARFDR.201112.0283

摘要

2009年一種新型流感病毒於美洲爆發，並散播至世界各國造成大流行。為了有效監控病情與防疫，醫療單位利用流行性感冒病毒快速診斷試劑以進行篩檢與監控。國內現行之流行感冒快速檢測試劑列為第一級醫療器材，上市販售前只需文件審查。本研究以先前執行「B型肝炎表面抗原」、「C型肝炎抗體」等血液病毒篩選用之第三等級體外診斷試劑效能評估之模式運用於流行性感冒病毒快速診斷試劑之效能評估；因A型流行感冒病毒之變異較快，症狀亦較為嚴重，故本研究著重於「A型流行性感冒病毒快速診斷試劑效能評估調查研究」之品質調查。99年度抽驗22品項，共45件市售流感快速診斷檢測試劑。本研究將流感病毒與血凝素（HA）標準品稀釋至各特定濃度，並依據各產品仿單進行操作，以檢示產品對不同濃度標準品之靈敏度反應。實驗結果顯示，其中有44件產品之靈敏度檢驗結果與其仿單標示不相符。上述結果顯示，利用快速診斷試劑進行篩檢雖可立即獲得檢驗結果，但可能因檢驗產品本身效能的不足而造成檢驗結果的不精確，進而導致流感防疫之漏洞。

關鍵字

流感病毒 ； 快速診斷試劑 ； 後市場調查

並列摘要

Influenza, commonly referred to as the flu, is an infectious disease that affects birds and mammals. Influenza spreads around the world in seasonal epidemics, resulting in thousands of deaths of people every year, up to millions in some pandemic years. In April 2009, an A (H1N1) influenza virus of swine lineage was detected in humans in the USA, and in just over a month has infected over 10,000 people in more than 40 countries. The type A viruses are the most virulent among all influenza types and cause severe disease. There are primarily two influenza A virus subtypes (H3N2 and H1N1) infecting humans worldwide during the past several decades.For the patient's well being and for the prevention of virus spread throughout the community, an early influenza diagnosis is required. Influenza A rapid test in-vitro diagnostic devices are the fastest diagnostic tools for the detection of influenza viruses currently. However, the Influenza rapid test in-vitro diagnostic devices were categorized into class 1 (low risk) medical devices in Taiwan. The registration and approval procedures for class 1 medical device imports in Taiwan are not as strict as that for other classes.We have evaluated the performance of several widely available influenza rapid test in-vitro diagnostic devices in Taiwan. Swine lineage A (H1N1) and the human seasonal influenza strain (H3N2) were cultured, and the cultured viruses and influenza hemagglutinin (HA) were diluted to specific infectivity titres. Viral and HA dilutions were assayed using the rapid test in-vitro diagnostic devices. The study indicated that most of the products detected virus or HA only when they were presented at high concentrations. Early diagnosis of infection can assist in the rapid management. However, the tests are not as sensitive as PCR assays and as such, negative results should be verified by a laboratory test.

並列關鍵字

influenza virus ； rapid test in vitro diagnostics ； post-market surveillance