The results of a major comparative study in Denmark on the reliability of sixteen Covid-19 serological tests represent bad news for Belgium. The kit ordered to a million copies by the Belgian authorities is the only one failed by the study. Belgium therefore finds itself with a large quantity of unreliable test kits, according to a joint survey by Knack and Le Vif / L’Express magazines.
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In early April, Hugues Malonne, Director General of the Federal Agency for Medicines and Health Products (FAMHP), assured that the DiaSorin test kit had “a sensitivity and specificity of 100%”, an affirmation that the manufacturer gave him – even did not support. Hugues Malonne then qualified his remarks.
The latter had ordered a million test kits for Belgium which had been immediately delivered to Belgian laboratories, without their having requested it. Serological tests are used in particular to screen medical personnel who have developed antibodies and who can therefore work in Covid services.
But a new study by 38 scientists from several university hospitals and research centers in Denmark disputes the reliability of the tests. With a specificity (the degree to which a test correctly identifies blood samples without antibodies) of 97.2%, the DiaSorin test is the only kit that does not meet the minimum target of 99%. The sensitivity (degree of detection of blood samples containing antibodies) of 84.6% is also disappointing.
Minister Philippe De Backer underlines that “two correctly conducted validation studies confirm the performance of the DiaSorin test”. He adds that the intention at the beginning of April was to “secure tests of sufficient quality for the Belgian market in order to avoid future shortages” and “not to select the best test”. Due to difficult circumstances and a limited supply, a large number of tests had to be purchased quickly.
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