<p class="ql-block">译文:美国监管机构警告说,由于突变(例如最近发现的B.1.1.7病毒变种),对SARS-CoV-2进行分子检测可能会导致假阴性结果的潜在风险。</p><p class="ql-block">美国食品和药物管理局(FDA)周五向临床实验室工作人员和临床医生发出警报。该机构警告说,如果通过该检测方法评估的病毒基因组部分发生突变,则任何用于检测SARS-CoV-2的分子检测均可能出现假阴性结果。</p><p class="ql-block">该机构表示,这些突变会影响总体测试准确性的风险很低,但FDA正在采取其他措施以确保授权测试保持准确。其中包括与测试开发人员合作以及继续进行数据分析以评估所有当前授权的分子测试。</p><p class="ql-block">FDA说,与所有病毒一样,SARS-CoV-2有望随时间发生突变,就像B.1.1.7变种的出现一样。</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无症状带毒者传播:</p> <p class="ql-block">尽量避免感染机会,釆用物理化学生化的方法应该可大幅度降低风险。比狼更狠的都來了,基因需要营养......</p>