SARS 抗體診斷試劑國家標準套組之製備   全文下載

Establishment of a Serological Panel for In Vitro Diagnostics of Severe Acute Respiratory Syndrome

嚴重急性呼吸道症候群（Severe Acute Respiratory Syndrome, SARS）為高致死率的傳染性疾病。由於SARS從疫情開始至結束僅約一年的時間（約91年11月至92年7月），無足夠的研究數據可供SARS體外診斷試劑之開發。為了因應未來SARS疫情再度流行時快速篩選可疑病患，SARS抗體診斷試劑國家標準套組為防疫上不可或缺的角色。在本篇研究中，作者利用疾病管制局（Taiwan CDC）所提供的20支SARS癒後血清與20支SARS陰性血清來製備SARS抗體診斷試劑國家標準套組。SARS國家標準套組可供未來食品藥物管理局（Taiwan FDA）於SARS抗體診斷試劑上市前審核時，作為效能評估之標準。SARS國家標準套組抗體反應性試驗利用SARS冠狀病毒（SARS-CoV）蛋白質萃取物、合成性SARS-CoV胜?片段及基因重組SARS-CoV蛋白來評估其免疫活性。結果顯示，SARS國家標準套組對於SARS-CoV蛋白質萃取物及合成性SARS-CoV胜?片段具有較佳的免疫活性，針對基因重組SARS-CoV蛋白則活性較差。此外，在ELISA及免疫螢光的實驗數據中顯示，SARS國家標準套組對於人類冠狀病毒229E 株不具交叉反應性，而對於人類冠狀病毒OC43 株則有弱反應性。基於上述結果，本研究所建立之SARS國家標準套組能適用於未來SARS抗體診斷試劑效能評估之用。"

Severe acute respiratory syndrome (SARS) is an infectious disease with a high mortality rate. Because SARS suddenly disappeared after an approximately 1-year-long pandemic period (November 2002 to July 2003), insufficient data was available for the development of in vitro diagnostics for SARS (SARS IVD). To rapidly identify cases in the event of future epidemics, it is necessary to establish a SARS serological panel. In this study, 20 SARS convalescent sera and 20 normal sera from the Taiwan CDC were used to establish a SARS sero-logical panel. This can be used as a standard for the Taiwan FDA to evaluate the effectiveness of SARS IVDs during the premarket approval process. To characterize the immunological activity, protein extracts containing SARS coronavirus (SARS-CoV) proteins, synthetic viral peptide fragments and recombinant viral proteins, were used to detect antibody reactivity. Results demonstrated that synthetic S, M, N peptide fragments and whole SARS-CoV protein extracts had stronger antigenicity than individual recombinant viral proteins. Moreover, results of the ELISA and the immunofluorescence assay indicated that our SARS panel had no cross-reactivity with the human coronavirus 229E, and displayed weak cross-reactivity with human coronavirus OC43. These findings suggested that our SARS serological panel is suitable for evaluating SARS IVDs.