Published May 29, 2020
As you may now be aware, all UK laboratories who carry out SARS-CoV-2 antibody testing on home self-collecting devices have been contacted by the MHRA. There is a national review being carried out by the MHRA on self-collecting devices for blood samples ‘finger prick samples’ for SARS-CoV-2 antibody testing. This review does not affect the testing of for SARS-CoV-2 antibody testing performed on venous drawn samples (SST / Serum or EDTA plasma samples) or for SARS-CoV-2 RT-PCR RNA swab testing. We have been notified by some customers that their samples were venous drawn samples and are in communication with our lab to discuss this on an individual basis.
Our lab has been in communication with the MHRA to establish the critical elements of the review of the service for serum derived from finger prick testing for SARS-CoV-2. We are working closely with the MHRA to resolve this issue and believe that it can be quickly resolved and are working with all interested parties to resume testing. We would like to reiterate that results from venous blood are valid.
Please accept our apologies for the interruption of your service by circumstances outside of our control.