SARS-CoV-2核酸國家標準品暨呼吸道病毒套組建立   全文下載

Establish the National Standard for SARS-CoV-2 and Respiratory Virus panel for Nucleic Acid Amplification Techniques (NAAT)

全球嚴重特殊傳染性肺炎（COVID-19）疫情嚴峻，現行實驗室大多以核酸擴增技術檢測方式篩檢嚴重急性呼吸系統症候群冠狀病毒2（SARS-CoV-2），參據衛生福利部食品藥物管理署（下稱食藥署）公告「因應新型冠狀病毒疫情緊急使用，核酸檢測試劑申請專案製造參考文件」，須有相對應標準品評估產品之效能，為扶植國內產業研發量能，食藥署國家實驗室旋即著手建立臺灣SARS-CoV-2核酸國家標準品以及呼吸道病毒套組。SARS-CoV-2核酸國家標準品透過細胞培養製備病毒原液，並以0.01%福馬林去活化，經初步定量，共製備SARS-CoV-2候選核酸國家標準品共324管（0.5 mL/管）。為增加標準品的客觀性及公信力，邀集國內外7機構進行共同標定研究，涵蓋4種不同分析方法及3個目標基因，經統計分析濃度訂定為6.35 log copies/mL。另，呼吸道病毒套組蒐集常見之呼吸道病毒HCoV-OC43、HCoV-229E、HCoV-NL63、Influenza A/B、Adenovirus、Respiratory syncytial virus、Rhinovirus以及Parainfluenza共9種病毒經適當方式去活化及定量，並於分裝後逐項供應。建立完成之SARS-CoV-2核酸標準品與呼吸道病毒套組已全數對外供應，提供業界作為核酸診斷試劑之研發及品質控管之依據，增加國內取得標準品之管道，加速我國產業相關試劑研發量能，守護國人健康。

In respond to the public health event of global SARS-CoV-2 epidemic, most laboratories use nucleic acid amplification techniques to screen for SARS-CoV-2. In reference to Taiwan Food and Drug Administration (TFDA), proclamation on manufacturing document for nucleic acid testing reagents in respond to coronavirus emergency usage, it is required to use the corresponding reference materials for evaluateing the products' efficiency. To support the domestic research and development industry, TFDA emergently made the SARS-CoV-2 national standards and respiratory relevant virus panel. The SARS-CoV-2 nucleic acid national standard was prepared by cell culture and inactivated with 0.01% formalin. The inactivated stock was divided into 324 vials (0.5 mL/vial) candidate National Standard (Lot: 109-03). To enhance the objectivity and credibility, the international collaborative study for the SARS-CoV-2 National Standard was held with 7 institutes, covering 4 different analytical methods and 3 target genes. The mean contents of the candidate National Standard was 6.35 log copies/mL. In addition, the respiratory virus panel collected 9 respiratory viruses including HCoV-OC43, HCoV-229E, HCoV-NL63, Influenza A/B, Adenovirus, Respiratory syncytial virus, Rhinovirus, and parainfluenza, which were inactivated and quantified by appropriate methods. The established SARS-CoV-2 nucleic acid standards and respiratory virus panel had all been provided to the manufacturer, which served as a basis for the research and development and quality control of IVD kits.