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Regulation of private Covid tests ‘vital’, says RPS

private covid tests

By Isabel Shaw

07 May 2021

All private Covid-19 tests must undergo quality and accuracy checks to ensure they meet all safety requirements before they are sold in pharmacies, the Royal Pharmaceutical Society (RPS) has said.

In a submission to the Department of Health and Social Care (DHSC) consultation on how to make sure all Covid tests in the UK market meet a satisfactory quality, RPS highlighted the need for a transition period so tests that are already available can be validated.

The consultation was launched in April after only 25% of privately-made lateral flow devices assessed through the Department of Health and Social Care’s lateral flow validation scheme were considered ‘of sufficient quality for procurement’.

As it stands, there are no legal requirements or independent validation of private Covid-19 tests, as there is for NHS provided tests.

Gino Martini, RPS Chief Scientist, said that it is ‘vital’ that all private tests go through the same independent validation process as those available on the NHS.

‘Patients need reassurance that the Covid-19 tests they use have met high levels of checks for safety, accuracy and effectiveness,’ he explained.

‘Without this process, we can’t be certain of the complete reliability of these tests. As a result, this can impact on how people act on the results of their tests, which could potentially put themselves and others at risk.

‘Pharmacists are well placed to support patients with Covid-19 testing, and we recommend that tests are only made available from regulated healthcare sites, such as a pharmacy.’

He added: ‘This means that vital interventions can be made to ensure the safety of the patient and advice is given on social distancing and isolation measures they may need to take.

‘The public and healthcare teams need appropriate guidance that will help them understand to only use and distribute tests that have undergone the required validation procedures.’

In February, The General Pharmaceutical Council (GPhC) announced it would no longer advise community pharmacies against providing rapid point of care/near person antibody tests for Covid-19 after reviewing updated guidance from Public Health England (PHE).

The regulator said it will expect pharmacies who do supply the tests to ‘carefully consider the PHE guidance’ and all ‘other relevant guidance’ when deciding which tests are appropriate.

The GPhC initially said in July last year that it was ‘not appropriate’ for pharmacy teams to be selling or recommending rapid antibody tests in line with advice published by PHE at the time.

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