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

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

https://www.hindustantimes.com/world-news/who-says-it-is-in-talks-with-china-s-bgi-on-covid-test-kit-after-swedish-complaint/story-UkxjxicneEzIQGGAtwNVDJ.html

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

https://www.nytimes.com/reuters/