長江生命科技(00775.HK)分銷10分鐘快速檢測新型肺炎試劑盒
長江生命科技(00775.HK)公布,已與新加坡Biolidics簽訂協議,分銷以血清學診斷為基礎之新型冠狀病毒肺炎(COVID-19)快速檢測試劑盒。
公司於兩周前公布分銷一項由新加坡科技研究院及陳篤生醫院共同研發之RT-PCR檢測試劑盒,連同是次與Biolidics簽訂的協議,長江生命科技現已引進兩項COVID-19檢測方案可供香港選擇。
公司指,Biolidics的快速檢測試劑盒易於使用,可於10分鐘內偵測血清、血漿或全血樣本中之SARS-CoV-2 IgM及IgG抗體,與COVID-19臨床診斷進行驗證比較之準確度逾95%。該快速檢測試劑盒的生產符合ISO 13485標準,並已獲得新加坡健康科學局之臨時認可,以及菲律賓食品及藥物管理局批准。該產品亦成功取得歐洲合格認證CE標記,可在歐盟市場進行銷售。同時,產品正透過美國食品及藥物管理局申請向醫療機構進行分銷、推廣及銷售,有關程序快將完成。
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