EU watchdog passes first blood test for diagnosing long Covid

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EU passes first blood test for diagnosing long Covid, though British patients will have to wait for UK regulator approval

Trials have shown the test detects immune system cells specific to long Covid Brussels has given the incellKINE Long Covid In Vitro Diagnostic test a CE mark  Patients from across the EU will be able to take the test from early next month British patients will have to wait for the UK regulator before the test is available

By Jonathan Neal For The Mail On Sunday

Published: 17:00 EDT, 3 September 2022 | Updated: 18:15 EDT, 3 September 2022

The first blood test for long Covid has been approved by European regulators, raising hopes for the millions of Britons suffering from the debilitating condition.

Trials have shown the test detects immune system cells specific to long Covid, helping doctors to differentiate it from other diseases with similar symptoms.

The incellKINE Long Covid In Vitro Diagnostic test has now received a CE mark, giving it approval for use in the European Union, after authorities accepted data from a study suggesting it was more than 90 per cent accurate across all Covid strains.

EU regulators have granted permission for a Long Covid test to be supplied from next month

Prevalence of long Covid is increasing in the UK and Europe – the World Health Organisation estimated that up to one in five patients infected with the virus go on to suffer a variety of mid- and long-term effects after recovering from the initial illness. Commonly reported symptoms include fatigue, breathlessness and brain fog

Dr Stephanie de Giorgio, a Kent GP focused on tackling long Covid, cautiously welcomes the test.

She says: ‘One of the problems that will remain is that we don’t have any treatments. But if this proves effective, it could give people some answers as to why they feel so rubbish.’

Its maker, IncellDx, plans to launch the test in Europe this month but will need to seek approval from UK watchdog, the Medicines and Healthcare Products Regulatory Agency, before it can go on sale here.

Prevalence of long Covid is increasing in the UK and Europe – the World Health Organisation estimated that up to one in five patients infected with the virus go on to suffer a variety of mid- and long-term effects after recovering from the initial illness.

Commonly reported symptoms include fatigue, breathlessness and brain fog.

Figures from the Office for National Statistics last week showed an estimated two million people – roughly three per cent of the population – were reporting problems lasting for more than four weeks after initial infection.

Of those, 22 per cent said their symptoms had persisted for at least two years. Despite this, the condition is little understood.

Dr Bruce Patterson, the chief executive of California-based IncellDx, says: ‘Long Covid presents a significant diagnostic and treatment challenge.’

Many of the symptoms, he adds, which include a wide range of cardiovascular issues, can easily be mistaken for painful conditions such as post-treatment Lyme disease syndrome, myalgic encephalomyelitis/chronic fatigue syndrome, fibromyalgia or even the common cold.

He adds: ‘Having an effective and objective tool to diagnose long Covid is absolutely essential.’

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