COVID-19: MHRA takes action to halt sales of finger-prick coronavirus antibody testing kits

29 May 2020

The MHRA is asking all providers of laboratory-based COVID-19 antibody testing services that use capillary blood collected by a finger-prick instead of venous blood samples, to temporarily stop providing this service until home collection of this sampling has been properly assessed, and validated, for use with these laboratory tests. This does not affect rapid, point of care tests or laboratory tests performed using venous blood samples.

According to the MHRA’s updated guidance, two manufacturers (Abbott and Roche) have issued statements about the intended use of their COVID-19 antibody tests. When these manufacturers developed the laboratory test, they validated it against venous blood samples. They do not yet have evidence to confirm a finger-prick blood sample will give reliable results.

 

Read the full details of the MHRA guidance, and the PHE guidance on use of rapid point-of-care tests for use in community pharmacies or at home, using the links below: