<p class="ql-block">譯文：美國監(jiān)管機構(gòu)警告說，由于突變（例如最近發(fā)現(xiàn)的B.1.1.7病毒變種），對SARS-CoV-2進行分子檢測可能會導(dǎo)致假陰性結(jié)果的潛在風險。</p><p class="ql-block">美國食品和藥物管理局（FDA）周五向臨床實驗室工作人員和臨床醫(yī)生發(fā)出警報。該機構(gòu)警告說，如果通過該檢測方法評估的病毒基因組部分發(fā)生突變，則任何用于檢測SARS-CoV-2的分子檢測均可能出現(xiàn)假陰性結(jié)果。</p><p class="ql-block">該機構(gòu)表示，這些突變會影響總體測試準確性的風險很低，但FDA正在采取其他措施以確保授權(quán)測試保持準確。其中包括與測試開發(fā)人員合作以及繼續(xù)進行數(shù)據(jù)分析以評估所有當前授權(quán)的分子測試。</p><p class="ql-block">FDA說，與所有病毒一樣，SARS-CoV-2有望隨時間發(fā)生突變，就像B.1.1.7變種的出現(xiàn)一樣。</p> <p class="ql-block">原文：</p><p class="ql-block">US regulators warned about the potential risk for false negative results with molecular tests for SARS-CoV-2 due to mutations such as a recently detected B.1.1.7 variant of the virus.</p><p class="ql-block">The US Food and Drug Administration (FDA) on Friday issued an to clinical laboratory staff and clinicians. The agency warned that false negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus's genome assessed by that test.</p><p class="ql-block">The risk that these mutations will affect overall testing accuracy is low, but the FDA is taking additional actions to ensure authorized tests remain accurate, the agency said. These include working with test developers and continuing data analysis to evaluate all currently authorized molecular tests.</p><p class="ql-block">Like all viruses, SARS-CoV-2 was expected to mutate over time, as seen with the emergence of the B.1.1.7 variant, the FDA said.</p> <p class="ql-block">而且一半以上的感染由無癥狀帶毒者傳播：</p> <p class="ql-block">盡量避免感染機會，釆用物理化學(xué)生化的方法應(yīng)該可大幅度降低風險。比狼更狠的都來了，基因需要營養(yǎng)......</p>