Sweden: Defective test kit misdiagnosed 3700 people
Wrong diagnosis for COVID-19
Some 3.700 people in Sweden were misinformed about being infected with a coronavirus due to a faulty test kit COVID-19 from China, the public health service announced today.
Folkhälsomyndigheten announced that the PCR test kits were made in China by BGI Genomics and distributed worldwide. The kit could not distinguish between very low levels of the virus and negative results, the service said.
The test kits were used in Sweden by people who took tests at home from March to August, according to the service.
"These are mainly people who had mild or no symptoms during the test, and received false positive results," the agency said in a statement.
These people are expected to be informed this week and the number of cases in Sweden will be adjusted accordingly, Folkhälsomyndigheten added.
"The supplier needs to adjust the performance required to use this test," said Karin Tegmark Wiesel, head of the agency's microbiology department.
The kit has been widely exported to other countries, he added, but could not give further details.
BGI Genomics, two of whose subsidiaries have been blacklisted by US companies involved in human rights abuses related to the treatment of Uighurs by China, was not immediately available for comment.
BGI Genomics was licensed for coronavirus testing kits by the US authorities in March and by the World Health Organization in May.
The defect in the test kit was detected by two laboratories during systematic quality controls. The Swedish service was not able to say how many tests were performed using the kit, but only a minority of cases appeared to be involved when the virus is at very low levels.
The Swedish authorities stressed that the wrong results had a marginal effect on the data of infections in the Scandinavian country.
Today, Tuesday, the public health service reported that since the first case was identified COVID-19 in the country, there were 86.891 confirmed cases in Sweden and 5.814 deaths.
Cases, admissions to intensive care units and deaths have dropped in recent weeks. The agency will present its strategy for easing some remaining restrictive measures at public events, such as football matches, next Tuesday.