Earlier this year, the federal government in Belgium bought one million serological test kits for Covid-19 – tests which turn out to be unreliable, according to a study carried out in Denmark.
The tests were ordered by the Federal Agency for Medicines and Health Products (FAMHP), with director-general Hugues Malonne claiming “a sensitivity and specificity of 100%” – a claim even the manufacturers themselves did not make.
The agency ordered one million test kits from the Italian manufacturer DiaSorin, at a cost of €7 million, which were then delivered unsolicited to laboratories. Serological tests are mainly used to determine which medical personnel have sufficient antibodies to be able to be deployed safely to Covid-19 facilities.
Now a comparative study by Danish researchers has revealed that the DiaSorin test is unreliable. The study tries the tests on 150 samples of Covid-19 infected blood, as well as a control group of 586 samples of uninfected blood.
The DiaSorin test managed to identify the presence of Covid-19 in 97.2% of samples – considerably lower than the 99% minimum demanded. And it was the only one of the 15 tests to fail the specificity test.
On the question of sensitivity – whether the test can identify the presence of antibodies in a given sample – the result of 84.6% success was described as “disappointing”.
Philippe De Backer (Open VLD), the government minister charged with procuring materials needed for the Covid-19 epidemic, said “two correctly conducted validation studies confirm the performance of the DiaSorin test”.
The intention in April, he said, had been to secure tests of sufficient quality for the Belgian market to avoid future shortages, and not to select the best test.
In addition, in the difficult circumstances and with limited supply, a large number of tests had to be purchased quickly, he said.