发错了，撤回？质量问题测出“假阳性”，澳公司召回20万个售美新冠检测盒
编辑:段敬裕来源:中国日报 2021-10-06 19:24
来源：中国日报 转载编辑：段敬裕
10月5日，美国食品药品监督管理局（FDA）发布通知称，澳大利亚埃卢姆公司出售给美国的部分家用新冠检测盒可能出现“虚假阳性结果”。
FDA要求使用了埃卢姆检测盒检测出阳性结果的人尽快联系医生复查，并敦促购买了质量问题检测盒的人们进行更换。People who used an Ellume kit and received a positive result were instructed to contact their healthcare provider for a follow-up. Everyone who owns a kit is urged to check the Ellume-provided list of problematic lots, sent out between April and August this year, and request a replacement after submitting receipts.作为首个可以完全在家进行的非处方新冠病毒检测工具，埃卢姆公司在去年12月获得FDA紧急使用授权后，已经向美国运送了大约350万个新冠检测盒。Ellume has shipped approximately 3.5 million test kits to the US after receiving FDA emergency use authorization in December as the first over-the-counter completely at-home Covid-19 test.
▲ Ads picture of Ellume Covid-19 home test kits
埃卢姆公司CEO肖恩·帕森斯对此回应称，大约有42.7万个测试盒受到了质量问题的影响，其中有一些还提供给了美国国防部。一半的测试盒已经被使用，测出了4.2万个阳性结果，目前还不确定这些阳性结果中有多少是假的。
About 427,000 test kits, including some provided to the US Department of Defense, were affected by the problem, Dr Sean Parsons, Ellume's chief executive, said in a phone interview. Roughly half have already been used, yielding about 42,000 positive results. As many as a quarter of those positives may have been inaccurate, Dr Parsons said, although he stressed that it would be difficult to determine exactly how many.
肖恩·帕森斯还提到，埃卢姆公司早先已经注意到了特定产品批次的虚假阳性结果，并查明了原因。不过，他以商业秘密为由，拒绝详细说明造成问题的原因。The company, which detected the problem in mid-September, traced the issue to variations in the quality of one of the raw materials used in the test kit. Dr Sean Parsons declined to specify the material in question, citing a desire not to publicly disclose precisely how the test kits work.
▲ Covid home test kits at the Ellume laboratory in Brisbane, Australia.
目前，埃卢姆公司正在召回有质量问题的检测盒。虽然没有公布具体数量，但《纽约时报》透露，埃卢姆召回的检测盒数量约为20万个，相当于售出总数的5.6%。While neither the FDA nor Ellume gave the exact amount of kits that are being recalled, the New York Times said the number was "nearly 200,000". That represents about 5.6 percent of the approximately 3.5 million test kits Ellume has shipped to the United States.
