News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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University of Oxford Researchers Use Spectroscopy and Artificial Intelligence to Create a Blood Test for Chronic Fatigue Syndrome

Spectroscopic technique was 91% accurate in identifying the notoriously difficult-to-diagnose disease suggesting a clinical diagnostic test for CFS may be possible

Most clinical pathologists know that, despite their best efforts, scientists have failed to come up with a reliable clinical laboratory blood test for diagnosing myalgic encephalomyelitis (ME), the condition commonly known as chronic fatigue syndrome (CFS)—at least not one that’s ready for clinical use.

But now an international team of researchers at the University of Oxford has developed an experimental non-invasive test for CFS using a simple blood draw, artificial intelligence (AI), and a spectroscopic technique known as Raman spectroscopy.

The approach uses a laser to identify unique cellular “fingerprints” associated with the disease, according to an Oxford news release.

“When Raman was added to a panel of potentially diagnostic outputs, we improved the ability of the model to identify the ME/CFS patients and controls,” Karl Morten, PhD, Director of Graduate Studies and Principal Investigator at Oxford University, told Advanced Science News. Morton led the research team along with Wei Huang, PhD, Professor of Biological Engineering at Oxford.

The researchers claim the test is 91% accurate in differentiating between healthy people, disease controls, and ME/CFS patients, and 84% accurate in differentiating between mild, moderate, and severe cases, the new release states.

The researchers published their paper in the journal Advanced Science titled, “Developing a Blood Cell-Based Diagnostic Test for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Using Peripheral Blood Mononuclear Cells.”

Karl Morten, PhD

“This could be a game changer as we are unsure what causes [ME/CFS] and diagnosis occurs perhaps 10 to 20 years after the condition has started to develop,” said Karl Morten, PhD, Director of Graduate Studies and Principal Investigator at Oxford University. “An early diagnosis might allow us to identify what is going wrong with the potential to fix it before the more long-term degenerative changes are observed.” Though this research may not lead to a simple clinical laboratory blood test for CFS, any non-invasive diagnostic test would enable doctors to help many people. (Photo copyright: Oxford University.)

Need for an ME/CFS Test

The federal Centers for Disease Control and Prevention (CDC) describes ME/CFS as “a serious, long-term illness that affects many body systems,” with symptoms that include severe fatigue and sleep difficulties. Citing an Institute of Medicine (IoM) report, the agency estimates that 836,000 to 2.5 million Americans suffer from the condition but notes that most cases have not been diagnosed.

“One of the difficulties is the complexity of the disease,” said Jonas Bergquist, MD, PhD, Director of the ME/CFS Research Center of Uppsala University in Sweden, told Advanced Science News. “Because it’s a multi-organ disorder, you get symptoms from many different regions of the body with different onsets, though it’s common with post viral syndrome to have different overlapping [symptoms] that disguise the diagnosis.” Bergquist was not involved with the Oxford study.

One key to the Oxford researchers’ technique is the use of multiple artificial intelligence models to analyze the spectral profiles. “These signatures are complex and by eye there are not necessarily clear features that separate ME/CFS patients from other groups,” Morten told Advanced Science News.

“The AI looks at this data and attempts to find features which can separate the groups,” he continued. “Different AI methods find different features in the data. Individually, each method is not that successful at assigning an unknown sample to the correct group. However, when we combine the different methods, we produce a model which can assign the subjects to the different groups very accurately.”

Without a reliable test, “diagnosis of the condition is difficult, with most patients relying on self-report, questionnaires, and subjective measures to receive a diagnosis,” the Oxford press release noted.

But developing such a test has been challenging, Advanced Science News noted.

How Oxford’s Raman Technique Works

Raman spectroscopy uses a laser to determine the “vibrational modes of molecules,” according to the Oxford press release.

“When a laser beam is directed at a cell, some of the scattered photons undergo frequency shifts due to energy exchanges with the cell’s molecular components,” the press release stated. “Raman micro-spectroscopy detects these shifted photons, providing a non-invasive method for single cell analysis. The resulting single cell Raman spectra serve as a unique fingerprint, revealing the intrinsic and biochemical properties and indicating the physiological and metabolic state of the cell.”

The researchers employed the technique on blood samples from 98 subjects, including 61 ME/CFS patients, 16 healthy controls, and 21 controls with multiple sclerosis (MS), Advanced Science reported.

The Oxford scientists focused their attention on peripheral blood mononuclear cells (PBMCs), as previous studies found that these cells showed “reduced energetic function” in ME/CFS patients. “With this evidence, the team proposed that single-cell analysis of PBMCs might reveal differences in the structure and morphology in ME/CFS patients compared to healthy controls and other disease groups such as multiple sclerosis,” the press release states.

Clinical Laboratory Blood Processing and the Oxford Raman Technique

Oxford’s Raman spectroscopic technique “only requires a small blood sample which could be developed as a point-of-care test perhaps from one drop of blood,” the researchers wrote. However, Advanced Science News pointed out that required laser microscopy equipment costs more than $250,000.

In their Advanced Science paper, the researchers note that the test could be made more widely available by transferring blood samples collected by local clinical laboratories to diagnostic centers that have the needed hardware.

“Alternatively, a compact system containing portable Raman instruments could be developed, which would be much cheaper than a standard Raman microscope, and [which] incorporated with microfluidic systems to stream cells through a Raman laser for detection, eliminating the need for lengthy blood sample processing,” the researchers wrote.

They noted that the technique could be adapted to test for other chronic conditions as well, such as MS, fibromyalgia, Lyme disease, and long COVID.

“Our paper is very much a starting point for future research,” Morten told Advanced Science News. “Larger cohorts need to be studied, and if Raman proves useful, we need to think carefully about how a test might be developed.”

Bergquist agreed, stating it’s “not necessarily something you would see in a doctor’s office. It requires a lot of advanced data analysis to use—I still see it as a research methodology. But in the long run, it could be developed into a tool that could be used in a more simplistic way.”

Though a useable diagnostic test may be far off, clinical laboratories should consider how they can aid in ME/CFS research.

—Stephen Beale

Related Information:

First Steps Towards Developing a New Diagnostic Test to Accurately Identify Hallmarks of Chronic Fatigue Syndrome in Blood Cells

First Ever Diagnostic Test for Chronic Fatigue Syndrome Sparks Hope

Developing a Blood Cell-Based Diagnostic Test for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Using Peripheral Blood Mononuclear Cells

Blood Test for Chronic Fatigue Syndrome Found to Be 91% Accurate

Scientists Develop Blood Test for Chronic Fatigue Syndrome

Biomarkers for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): A Systematic Review

Biomarker for Chronic Fatigue Syndrome Identified

Patient Safety Guru Lucian Leape, MD, Discusses How Medical Laboratories and Pathology Groups Can Do More to Improve Patient Safety

Panel of webinar speakers included several physicians, a pathologist, and a director from the Food and Drug Administration (FDA)

Patient safety continues to be a major factor in the ongoing transformation of healthcare in the United States. As it does, more scrutiny is being given to how medical laboratories and anatomic pathology groups can contribute to improving patient safety.

One example of the heightened scrutiny of patient safety as it relates to clinical laboratory testing services was a recent webinar at the Harvard T.H. Chan School of Public Health and the online healthcare site, Stat. Titled “Medical Tests: Inaccuracies, Risks and the Public’s Health,” this webinar featured nationally-known healthcare experts and policy makers.

Issues of patient safety associated with medical laboratories was a major topic during this webinar, including discussion about concerns associated with the clinical use of laboratory-developed tests. (more…)

New Institute of Medicine Report Finds Diagnostic Errors Continue to Put Americans at Risk

Pathologists and clinical laboratories could help reduce error rate through greater collaboration with providers

Expect the topic of diagnostic mistakes to get more media attention in coming years. That is consistent with the efforts of healthcare policymakers to improve patient safety while making it easier for consumers to access information about the quality and cost when selecting hospitals, physicians, and medical laboratories.

One opening salvo in this campaign is a new report from the Institute of Medicine (IOM) titled “Improving Diagnosis in Health Care.” It concludes that Americans will receive at least one wrong or late diagnosis in their lifetime. The rate of diagnostic errors is a patient-safety issue in which pathologists and clinical laboratories could play an important role in reducing.

Pathologists often know which physicians in their community routinely order inappropriate or wrong tests for patients. That is why pathologists could be instrumental in reducing diagnostic errors through better communication with providers to ensure doctors not only order the correct clinical laboratory tests, but also select the appropriate therapies based on test results. (more…)

Computer-Assisted Diagnostics Systems Help Doctors Get It Right; May Help Improve Utilization of Clinical Pathology Laboratory Tests

Computer diagnostics could offer opportunity for pathologists and clinical laboratory managers to add value to clinicians in diagnosing diseases

Efforts are intensifying to develop computer software that successfully emulates the skills of highly proficient diagnosticians. The motivation is increased pressure to reduce medical errors, including misdiagnosis. This is welcome news to many pathologists, who often see physicians ordering the wrong laboratory tests.

Diagnostic mistakes account for about 15% of errors that result in harm to patients, according to the Institute of Medicine (IOM), a story in The New York Times reported. (more…)

Could Patient-Error Reports Cause Pathologists To Be Responsible for Other Providers’ Mistakes?

Who is responsible when a patient is misdiagnosed because the patient’s physician read a clinical laboratory test report incorrectly?

Could clinical pathologists be held responsible for medical errors caused by other providers? That’s a possibility under a proposal from the federal Agency for Healthcare Research and Quality (AHRQ).

AHRQ is seeking approval for a prototype of a new reporting system for medical errors, AHRQ Director Carolyn M. Clancy, M.D., told The New York Times in a story published on September 22, 2012. “Currently there is no mechanism for consumers to report information about patient safety events,” she said.
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