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MHRA Action Taken To Halt Sales Of Fingerprick Coronavirus (COVID-19) Antibody Test Kits

MHRA action taken to halt sales of fingerprick coronavirus (COVID-19) antibody test kits

MHRA have taken action to halt the sales of fingerprick antibody tests for coronavirus (COVID-19), utilising capillary bloody, due to concerns regarding reliability.

MHRA have asked providers of laboratory-based COVID-19 antibody testing services using capillary blood collected by a fingerprick, to temporarily stop providing this service until home collection of this sample type has been properly assessed and validated for use with these laboratory tests.

Using unvalidated sample types may lead to unreliable results and as such MHRA are working closely with the service providers, laboratories and test manufacturers to resolve the regulatory and patient safety issues.

Recently, MHRA updated their guidance on home antibody testing kits to ensure that the public and industry have the latest information on the reliability of test results and what they mean.

Please note that this does not affect rapid, point of care tests or laboratory tests performed using blood taken from the vein. Also people who have purchased one of these sampling kits, and received an antibody test result, should not consider the result to be reliable and should not take any action based on it. 

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