WHO says it is in talks with China’s BGI on test kit after Swedish complaint

Reading Time: < 1 minute

The World Health Organization said on Thursday it was looking into whether “observed irregularities” in a COVID-19 PCR swab test made by China’s BGI Biotechnology (Wuhan) Co, Ltd were linked to how it was used in Sweden.

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.

“Specifically, WHO has contacted the manufacturer and requested a root cause analysis… We are continuing the work with BGI to determine if further action is required,” it said.