COVID-19:中国制造的电晕检测工具包也有缺陷:制造了BGI基因组学
BGI基因组学产品:
在瑞典,检测到约3700例假阳性。
如果样本包含少量病毒,将无法区分阳性和阴性,从而导致“假阳性”。
瑞典公共卫生服务:
8月25日,它发生在从中国进口的新型冠状病毒感染检测试剂盒中。
宣布有成千上万的“假阳性(即使没有感染也显示出阳性反应)”。
公共卫生声明:
有问题的PCR测试试剂盒是由一家中国大型基因组分析公司生产的。
由BGI Genomics制造,隶属于“大中华”集团。
正常质量控制检查:
在两个实验室的定期检查和质量控制检查中,发现发生了误报。
当样品中包含的病毒数量极少时,无法区分阳性(感染)和阴性(未感染)。
这两个实验室分析了从日本10个地区收集的样本。
结果是,
首都斯德哥尔摩
西约塔兰省
盖夫堡县,
西博滕省,
Vasteras,
达拉纳
Vasternorrland县,
南曼德县
布莱金厄县,
发现在九个区域中获得了不正确的测试结果。
美国也已于三月批准使用。
欧盟当局和世界卫生组织(WHO):
该套件从中国出口到包括瑞典在内的许多国家。
瑞典公共卫生部已将此案告知欧盟当局和世界卫生组织(WHO)。
新闻周刊日本版网站
https://www.newsweekjapan.jp/stories/world/2020/08/3700-1.php
WHO says it is in talks with China’s BGI on Covid test kit after Swedish complaint
The WHO
said it had asked the maker for a “root cause analysis”.China’s BGI Genomics
said on Wednesday its diagnostic coronavirus testing kit has “relatively high accuracy”, a day after Sweden said about 3,700 people received false positive results due to a fault in the company’s product.The WHO, which has approved the tests for emergency use,
said in reply to a Reuters query:
“WHO was notified and has activated the complaint procedure for in vitro diagnostics … to gauge if the observed irregularities were due to the way the test was used.-
world news – Hindustan Times
Sweden uncovers 3,700 false positives from COVID-19 test kit
https://medicalxpress.com/news/2020-08-sweden-uncovers-false-positives-covid-.html
Thousands of Swedes Got False Positive COVID-19 Result Due to Test Kit Fault – The New York Times