COVID-19: Corona Inspection Kit Made in China Also Defect: BGI Genomics Manufactured
BGI Genomics Products:
In Sweden, about 3700 false positives were detected.
If the number of viruses contained in the sample is small, it will not be possible to distinguish between positive and negative, resulting in “false positives”.
Swedish Public Health Service:
On August 25, it occurred in a new coronavirus infection test kit imported from China.
Announced that there were thousands of “false positives (a positive reaction was shown even though there was no infection)”.
Public Health Statement:
The PCR test kit in question was manufactured by a major Chinese genome analysis company.
Manufactured by BGI Genomics, which is under the umbrella of the “Greater China” group.
Normal quality control check:
In the regular and quality control checks of the two laboratories, it was found that false positives occurred.
It was not possible to distinguish between positive (infected) and negative (non-infected) when the number of viruses contained in the sample was extremely low.
The two laboratories analyzed samples collected from 10 regions in Japan.
as a result,
Stockholm, the capital
Västra Götaland County,
Gävleborg County,
Vasterbotten County,
Vasteras,
Dalarna,
Vasternorrland County,
Sodermanland County,
Blekinge County,
It was found that incorrect test results were obtained in nine areas.
The US has also approved use in March.
EU Authorities and World Health Organization (WHO):
This kit is exported from China to many countries including Sweden.
The Swedish Public Health Department has informed EU authorities and the World Health Organization (WHO) of this case.
Newsweek Japan version site
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