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Exclusive: PHE Covid-19 antibody test advice ‘out-of-date’ and ‘inappropriate’, says test distributor


By Isabel Shaw
Reporter

22 Jul 2020

Advice from Public Health England (PHE) that community pharmacy teams should not supply patients with rapid Covid-19 antibody tests is ‘out-of-date’ and ‘inappropriate,’ as it takes ‘no account of recent developments,’ test distributor Pharmadoctor has said.

In a letter sent to the General Pharmaceutical Council (GPhC), seen by the Pharmacist, Graham Thoms – the Chief Executive Officer of Pharmadoctor – addressed a communication from the GPhC to pharmacy contractors yesterday (21 July) stating that the regulating body ‘does not regard it as appropriate for community pharmacy to be selling and recommending rapid antibody test kits’.

In line with advice published by PHE in March, Duncan Rudkin, chief executive of the GPhC has asked pharmacies to ‘support public health’ by not offering the test to the public, despite it being legal to do so.

According to Mr Thoms, many pharmacists are ‘raging’ at the advice GPhC has now issued, as it makes them feel that the body ‘doesn’t trust them to deliver a professional service’.

‘The PHE advice takes a one-size-fits-all approach, conflating several very different sorts of tests and testing procedures’, Mr Thoms said in his letter to the GPhC. ‘As a result, the use of reliable rapid antibody tests is being stifled to the detriment of healthcare professionals and the public.’

He added: ‘When we look at the PHE advice, it does not seem to be relevant to the tests we are supplying to pharmacies, nor the antibody testing service being provided in hundreds of UK pharmacies.’

The tests distributed by Pharmadoctor are ‘highly sensitive and specific at identifying Covid-19 IgG antibodies with results comparable to the lab-based antibody tests which have been validated by PHE and are on open sale,’ he said.

Mr Thoms acknowledged the regulator’s concern that the public may not understand that the presence of Covid-19 antibodies is not a guarantee of immunity to the virus. The GPhC said in their advice: ‘During this ongoing national public health crisis, any activity that may contribute to false results or assurances that then impact on public behaviour should not be supported.’

However, Mr Thoms suggested that community pharmacists ‘are best placed to communicate this by providing a professional antibody testing service to members of the public who want to know their antibody status’.

As of today (22 July), the supplier has provided 513 pharmacies across the UK with Biopanda COVID-19 Rapid Test Kits.

The test uses a sample of blood from a finger prick test and produces results in 10 minutes. It should only be performed and evaluated by a healthcare professional such as a pharmacist or pharmacy technician and cannot be sold directly to the public.

Earlier this month, evidence emerged from a report on Covid-19 antibody testing – presented to the government’s Scientific Advisory Group for Emergencies (SAGE) – which said ‘commercial tests that have come to market more recently are performing well’.

While PHE recognised the improvements in test performance, the body told the Pharmacist that it is not updating guidance on the tests at this time (22 July), as the SAGE report also describes the potential for false-positive and false-negative results. It also highlights the continued areas of uncertainty around the presence of antibodies and immunity.


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