COPENHAGEN (Reuters) – Denmark has asked for a new supply of a quarter million antibody test kits from Chinese diagnostics firm Livzon after a batch of tests proved too inaccurate, healthcare authorities said in a statement on Wednesday.
Demand for antibody test kits, which show whether a person has previously been infected by COVID-19, has soared since the virus outbreak, prompting large pharmaceutical firms to ramp up production.
Denmark has ordered a total of 1.4 million kits from Chinese supplier Livzon to be used for research purposes, said Danish Regions, a government organisation tasked with ensuring the quality of the Danish healthcare system.
“The Regions are awaiting a response from the Chinese supplier, which delivered a batch of antibody tests with too high sensitivity deviation,” it said in a press release.
Livzon was not immediately available for comment.
Testing for antibodies could give countries a measure of immunity in society, although it remains unclear whether a presence of antibodies to the coronavirus means permanent immunity.
But test kits vary in so-called sensitivity, a measure of how accurate they are.
In late April, health authorities in India recommended not using testing equipment bought from two Chinese suppliers due to quality issues, including kits from Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics.
Livzon responded in a statement at the time saying it regretted the decision of the Indian authorities, and that its SARS-CoV-2 antibody test complies with regulation and quality control requirements.
Danish Regions has asked for a batch of around 250,000 tests to be replaced, which it said showed only a sensitivity of 69%, lower than a previous batch with an acceptable sensitivity of 82%. It said quality tests were being performed on the remaining batches.
One test cost around $6, it said.
(Reporting by Nikolaj Skydsgaard; Editing by Chizu Nomiyama)
