Regulator ‘following up’ Boots’ provision of rapid point of care COVID-19 antigen test

The General Pharmaceutical Council is looking into Boots’ roll-out of a rapid antigen test for COVID-19, with Public Health England guidance advising that such tests should not be provided by community pharmacies.

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The rapid antigen test Boots is offering will be available in a number of the multiple’s stores to customers who do not have symptoms

The General Pharmaceutical Council (GPhC) is to “follow up” Boots’ announcement that the multiple plans to roll out a rapid point of care antigen test for COVID-19 in “the next few weeks”.

Government guidance is that such tests should not be provided by community pharmacies, and the GPhC said it will follow up the announcement with the chain and “other key stakeholders”.

The test will use a device manufactured by LumiraDx, which processes swab samples to give results in 12 minutes.

Boots said in a statement on 26 October 2020 that the devices will be rolled out to “selected stores” and will be used only for customers who do not have symptoms.

“This way of testing will help customers to quickly get peace of mind, revolutionising the speed of testing across the UK and reducing inappropriate use of the Government testing programme,” the statement said.

However, guidance published by Public Health England (PHE) in May 2020 advises against using rapid point of care tests for both COVID-19 antigens and antibodies.

“The current view by PHE is that use of products that give a very rapid result is not advised; some of these products look for virus, while others look for the body’s immune response to the virus,” the guidance says.

“Such tests are very rapid and can work on a range of specimens including serum, plasma or finger-prick whole blood.”

PHE told The Pharmaceutical Journal that it would not be updating its guidance in this area.

Pharmacies have previously been warned by the GPhC against providing rapid point of care antibody tests in light of this guidance.

When asked how the multiple’s new offering sits within this guidance, Boots said the device has been tested and authorised by the Food and Drug Administration in the United States and has achieved CE marking for use in Europe.

The company added that the LumiraDx has been tested in clinical trials on more than 500 patients and provides accurate results — over 97% of tests agree with the outcome of a PCR comparator — within 12 minutes from individuals at risk of, or with symptoms of, COVID-19, as part of the trial.

Seb James, managing director of Boots, said the multiple “has supported the government’s COVID-19 testing programme from the very start and offering this new in-store service is the next step in our efforts to fight against the pandemic”.

“We hope that, by offering this testing option in local community stores, Boots can help ease pressure on the NHS and the government by providing additional access to testing and crucial reassurances for people across the UK.”

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Citation
The Pharmaceutical Journal, October 2020;Online:DOI:10.1211/PJ.2020.20208486