First Diagnostic Test for Long COVID Provides More Than 90% Accuracy

The prevalence of long COVID is thought to be increasing across the UK and Europe, with significant impact both to individuals and to the economy. In April the European Commission said that between 60% and 80% of the EU population was estimated to have been infected with acute COVID-19, while the World Health Organization estimates long COVID affects up to 20% of patients infected with acute COVID. A recent study found that six in 10 patients had at least one persistent COVID-19 symptom, and that patients whose symptoms have not resolved by 15 weeks are likely to experience symptoms for at least a year. Now, the first diagnostic designed to identify patients with long COVID has received CE-IVD marking in Europe and is ready for formal launch in countries accepting the designation in September of this year.

IncellDx (San Carlos, CA, USA) has developed a simple blood test that can help to objectively diagnose patients suffering from Post-Acute Sequelae of COVID-19 (PASC), commonly known as long COVID. The test was developed based on clinical studies published in the peer reviewed journal Frontiers in Immunology, which showed that IncellDx researchers generated credible, objective disease scores for long COVID using machine learning and artificial intelligence to measure and analyze sets of inflammatory markers called cytokines and chemokines. The studies also demonstrated that patients with previous COVID-19 infection and lingering symptoms were found to have a distinct immunologic profile characterized by patterns of inflammatory marker expression. In a subsequent publication, IncellDx found SARS CoV-2 S1 spike protein in monocytic reservoirs of long COVID patients up to 15 months after acute infection.

“Long COVID presents a significant diagnostic and treatment challenge for patients. Many of the symptoms that are associated with long COVID, including fatigue, brain fog, shortness of breath, insomnia, and a wide range of cardiovascular issues, can easily be mistaken for other conditions like post-Lyme, ME-CFS, Fibromyalgia, or even the common cold,” said Bruce Patterson, MD, CEO of IncellDx. “Having an effective - and importantly an objective - tool to diagnose the condition is absolutely essential. An objective test that can detect immune signatures specific to long COVID is vital for effective diagnosis and to enable patients to seek effective treatment.”

“With an estimated 200 million worldwide suffering, and established negative impact to health systems and economies in Europe, the US, India and South America, long COVID is already becoming the world’s next global public health crisis,” Patterson said. “We are pleased that CE marking was granted for the IncellDx incellKINE long COVID test in Europe, and that the test will be made widely available to physicians and their patients soon.”

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