Sweden's public health authority says BGI's COVID-19 test returned thousands of false positive results, according to Reuters.
BGI's COVID-19 test received an Emergency Use Authorization from the US Food and Drug Administration in March and an Emergency Use Listing from the World Health Organization in May, Reuters adds. It is a real-time fluorescent RT-PCR-based assay to detect SARS-CoV-2.
Sweden's Public Health Agency says 3,700 people there were erroneously told they had COVID-19 based on the test, Reuters says. It adds that the test appears to not be able to distinguish between samples with low virus levels and no virus.
"The supplier must adjust the performance that is required for this test to be used," Karin Tegmark Wisell, the head of microbiology at Sweden's Public Health Agency, tells it. The news agency adds that the Swedish labs using the test have adjusted their methodology.
There have been 87,072 COVID-19 cases and 5,817 deaths in Sweden, according to the Johns Hopkins University COVID-19 dashboard.