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Scientists in the United Kingdom say they have developed a blood test who can diagnose myalgic encephalomyelitis,chronic fatigue syndrome ,Me/CFS) with 96% accuracy – first of its kindThis will be exciting news for many people living with a debilitating condition.
Despite affecting millions of people worldwide, the condition is poorly understood. It is characterized by persistent fatigue that does not improve even with rest, and malaise after exertion – worsening of symptoms after even minor physical or mental activity.
Yet with no reliable tests, many people wait years for a diagnosis. This usually depends on the symptoms meeting certain diagnostic criteria. But diagnostic criteria can be controversial because they vary around the world, and many are outdated.
An accurate blood test can be a game-changer for diagnosis.
So, how excited should we be? Here’s what we know.
How does diagnosis work without testing?
Currently, you can only receive a diagnosis if you experience disabling fatigue, accompanied by malaise after exertion, for at least six months – which is one of the major symptoms according to most diagnostic criteria.
But people with the condition often experience a wide range of other symptoms, including headaches, muscle or joint pain, sleep disturbances, dizziness, racing heart, and problems with memory, thinking, and decision-making.
Therefore, physicians must also rule out other conditions with overlapping symptoms.
This means that diagnosis largely depends on the physicians’ knowledge of ME/CFS and their willingness to listen to the patient’s complex symptom history. This process can take years – and delaying diagnosis has real consequences.
Evidence suggests that early intervention is key to recovery. Rest during the early stages of the illness is likely to improve long-term outcomes, as has been suggested for a clinically similar illness, Long COVID.
One study showed that delayed ME/CFS diagnosis was associated with worse outcomes, meaning the chances of recovery were lower and the chances of developing more severe symptoms were increased.
Without a definitive diagnosis, patients routinely face disbelief about their illness and have limited access to information, health care services, and medical benefits.
Frequent delays in diagnosis may contribute to the condition’s low recovery rate, estimated at only 1–10%.
What was seen in the new study
To develop a diagnostic test, the new study identified biomarkers that may be specific to people with the condition.
In this case, the biomarkers relate to epigenetics – changes in the structure of a person’s chromosomes, affecting which genes can be turned on or off.
These changes are caused by environmental influences such as stress, infection, and exercise. So, when someone develops ME/CFS, the disease may change the structure of their chromosomes – but until now, researchers have not identified what this would look like.
About the author
Sarah Annesley is a Senior Postdoctoral Research Fellow in Cell and Molecular Biology at La Trobe University.
This article is republished from Conversation Under Creative Commons license. read the original article,
Researchers examined blood samples from people they knew had ME/CFS and identified nearly 200 such biomarkers. These changes created a specific biological “signature” that was not present in the blood of healthy participants in the comparison group.
This signature was very accurate in correctly identifying which samples were from people with the condition and which were from a comparison group.
According to the researchers, the sensitivity of the test was 92% – that is the probability that someone will see a positive result if they have the condition. Its specificity was 98%, meaning it could reject negative cases.
This resulted in an overall diagnostic accuracy of 96%.
So, is it a success?
This research is promising, but it is still early days. This was a proof-of-concept study, meaning small-scale research to initially test whether an idea could work.
In this case, researchers explored the idea that structural changes in chromosomes could be used as a biomarker of ME/CFS. Their results show they can do so.
However, there were several limitations. The study included a relatively small number of people: 47 participants with severe ME/CFS and 61 participants in a healthy “control” group.
The ME/CFS group had more women, and its participants were so severely affected that they had to stay home. So perhaps their activity levels were lower than the control group.
We know that a person’s gender and activity level can affect these chromosomal changes, so this may affect the results.
ME/CFS symptoms
NHS
There are 4 main symptoms of ME/CFS:
- Feeling extremely tired (fatigue) all the time, which may make daily activities such as bathing, or going to work or school difficult
- Sleep problems, including insomnia, sleeping too much, feeling like you haven’t slept enough, and feeling tired or groggy when you wake up
- Problems with thinking, concentration, and memory (brain fog)
- Symptoms become worse after physical or mental activity, and possibly take several weeks to recover (also called post-exercise discomfort or PEM).
To develop a diagnostic test that can be widely used, several important steps remain.
There is a need to determine how much an individual’s gender and exercise level affect these biomarkers. Biomarkers will also need to be validated in larger, more diverse groups, including people with less and more severe symptoms and from different backgrounds than in this study.
To confirm that these biomarkers are truly specific to ME/CFS, they need to be compared to other conditions that share similar symptoms, such as multiple sclerosis and fibromyalgia.
Finally, it is also important that if a test is developed, it should be cheap and accessible.
ME/CFS remains a severely underdiagnosed condition, and the lack of reliable testing is leading to delays in care and poor outcomes. Identifying biomarkers, as was the aim of this study, is a promising first step.