2022-01-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/652321以具高特異性與敏感性單源抗體，開發可檢測具感受性物種動物、各種亞型別禽流感病毒非結構蛋白NS1與核蛋白抗原檢測方法或套組；本新建立檢測工具可做為新發禽流感疫情的早期偵測利器，扮演早期預警系統的重要成員角色。為達到研發與生產Strip (Immunochromatographic) 快篩 (Rapid test) 型態試劑，俾應用於現場，冀即時檢測、即時處理疫情的預定目標，111年以發展檢測NP抗原試劑為主軸，檢測NS1抗原試劑為輔，與合作廠商彼此配合，已完成NP及NS1抗原試劑組「Strip原型」各兩式，於包含六種A型流感病毒亞型(H1N1/H1N2/H3N1/H5N2/H6N1/H7N9)，包含其模擬、試驗感染生材共八種的敏感性(Sensitivity, Sn)及(Specificity, Sp)測試，兩式NP Strip原型檢測抗原的敏感性皆遠高於NS1 Strip原型；兩式NP Strip原型都具不與SPF、IBV反應之特異性結果，可供合作廠商最終能取得單源抗體關鍵生材的完整使用權，將「NP Strip原型」擴為量產型生產上市，做為田間檢測新發禽流感疫情的篩檢工具。To develop avian influenza virus (AIV) nucleoprotein and non-structural protein NS1 detecting method or kit which will be based on highly specific and sensitive monoclonal antibody against NP and NS1. The diagnostic method is capable of applying on all susceptible animals and all AIV subtypes. Also, the method can be an early detection tool of AIV infection and play an important role of disease early warning system. To reach the goal of obtaining the chromatographic based rapid test kit, the Strip, for the field application of real-diagnosis and real-implementation of disease control measures, the second year of this two-year project aims for the work with the cooperated company on the development of NP Strip and supplemented by the development of NS1 Strip. Finally, two NP and NS1 「Strip prototype」each have been completed and examined on eight test bio-samples to obtain the sensitivity (Sn) and specificity (Sp) this year. Those bio-samples include six subtype of IAV, H1N1/H1N2/H3N1/H5N2/H6N1/H7N9 cell lysates, experimentally infected chicken swab and IBV. The Sn of both NP 「Strip prototype」are all far-higher than that of the NS1「Strip prototype」. Also, both NP 「Strip prototype」show the absolute Sp from samples of IBV and SPF. Based on the result, the cooperator should get the full access of the key bio-materials, six different monoclonal antibodies, after the cooperation period. The massive productionof the「 NP Strip」can be adjusted then, and marketed to apply on the surveillance of animal influenza in the field.禽流感病毒奈米金抗原快篩試劑單源抗體免疫色層分析試片Avian influenza virusGold nanoparticlesAntigen rapid testMonoclonal antibodyImmunochromatographic strip