UK regulator tells retailers to halt Covid-19 antibody test deliveries

UK regulator tells retailers to halt Covid-19 home antibody test deliveries
// MHRA warns unvalidated samples using finger prick may lead to unreliable results
// PHE has approved the testing kits for use by health professionals the NHS, but not for use at home

UK regulators have told retailers to halt the sale and deliveries of home testing kits for coronavirus antibodies as doubts persist over their accuracy.

The Medicines and Healthcare products Regulatory Agency (MHRA) said labs must stop processing the blood samples derived from finger prick tests while it examines how well they actually work.

MHRA devices director Graeme Tunbridge, said the use of unvalidated samples may lead to unreliable results.

READ MORE: Superdrug the first retailer to offer DIY Covid-19 antibodies testing kit

“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 on it,” he said.

Retailers in the UK that have started selling home antibody tests include Superdrug and Babylon.

The testing kits are made by the healthcare technology firm Abbott and have been approved by Public Health England (PHE) for the NHS to use for frontline health and care workers.

The MHRA is questioning if a home blood sample, via a finger prick, sent in the mail to the lab provides a result that is as accurate as one taken within a clinic, where a healthcare professional draws blood from a vein.

PHE has not approved any for use at home.

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  1. Pune based OptraLABS announced that it has received approval from ICMR towards its COVID-19 rapid test kits named ‘Optra-Shield’. Based on studies conducted at the National Institute of Virology (NIV) Pune, Optra-Shield test kits showed 99 per cent specificity and 95 per cent sensitivity to detect immunity post-COVID-19 infection


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