出大包了?藍委驚爆:福吉美原廠說明書 寫驗不出Omicron
https://www.chinatimes.com/realtimenews/20220602001781-260407

出大包了?藍委驚爆:福吉美原廠說明書 寫驗不出Omicron - 政治

高端疫苗副董事長陳燦堅創立的福又達公司,日前高速取得唾液快篩「福吉美」進口許可,引發在野黨質疑。國民黨立院黨團今開記者會踢爆,「福吉美」原廠說明書上就寫說驗不出Omicron,衛福部在Omicron高峰期緊急核准這

https://www.chinatimes.com/realtimenews/20220602001781-260407
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國內有以Omicron做檢測,結果符合規定;食藥署也緊急澄清,強調無論原廠產品說明書是否列出可測得變異株種類,皆要求業者評估產品檢測變異株的性能,並檢附相關報告,確認可檢測Omicron變異株才核准。

食藥署考量病毒株持續變異,無論原廠產品說明書是否列出可測得變異株種類,皆要求業者應根據病毒突變、變異株的發生率,評估產品檢測新出現的突變和變異株性能,並檢附變異株性能的評估報告,經審查確認可檢測Omicron變異株,才得以獲得核准。

References

https://www.upmedia.mg/news_info.php?Type=24&SerialNo=146163

福吉美唾液快篩驗不出Omicron? 陳時中:經國內檢驗,符合規定--上報

國民黨立院黨團今天(2日)舉行記者會,指控日前短時間取得進口許可的「福吉美」唾液快篩竟驗不出Omicron。......

https://www.upmedia.mg/news_info.php?Type=24&SerialNo=146163

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