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King’s College London Researchers Discover Causal Link between Blood Type and COVID-19 Severity; May Provide Clinical Laboratories with a Useful Diagnostic Insight

Findings are ‘a vital first step in discovering potentially valuable targets for development of new [COVID-19] treatments,’ noted co-first author of the study

Researchers at King’s College London (KCL) have determined that levels of certain blood proteins specific to each person’s blood type can be “causally linked” to an increased risk of hospitalization and death from a COVID-19 infection. The scientists also found that a person’s genetics play a key role in establishing the levels of those proteins in the blood.

This is relevant for clinical laboratories—particularly hospital/health system laboratories—because testing for specific proteins in the blood by medical laboratories could help flag incoming patients at higher risk for an acute COVID-19 infection.

Also, “By identifying this suite of proteins, the research has highlighted a number [of] possible targets for drugs that could be used to help treat severe COVID-19,” noted a KCL news release.

Identifying certain drugs that would be more effective for specific individuals or healthcare groups is a core goal of precision medicine.

The KCL researchers published their findings in the journal PLOS Genetics, titled, “Proteome-wide Mendelian Randomization Identifies Causal Links between Blood Proteins and Severe COVID-19.”

Alish Palmos, PhD
“We have used a purely genetic approach to investigate a large number of blood proteins and established that a handful have causal links to the development of severe COVID-19,” said Alish Palmos, PhD (above), Postdoctoral Research Associate, King’s College London Social, Genetic and Developmental Psychiatry Center, and co-first author of the study. “Honing in on this group of proteins is a vital first step in discovering potentially valuable targets for development of new treatments.” Medical laboratories may soon be able to use this knowledge as a way to determine risk for severe COVID-19 hospitalization, as well as to guide decisions on how to use new precision medicine drugs for combating the infection. (Photo copyright: Twitter.)

Genetic Variants Linked to Causality

Since the COVID-19 pandemic began in late 2019, scientists and researchers have been vigorously trying to understand the SARS-CoV-2 coronavirus and determine why some patients have more severe symptoms than others.

To conduct their study, the KCL researchers screened more than 3,000 blood proteins to identify which proteins have a causal link to hospitalization risk, the need for respiratory support, and death from a severe COVID-19 infection.

“Causality between exposure and disease can be established because genetic variants inherited from parent to offspring are randomly assigned at conception similar to how a randomized controlled trial assigns people to groups,” said Vincent Millischer, MD, PhD, Medical University of Vienna and co-first author of the study in the KCL news release.

“In our study, the groups are defined by their genetic propensity to different blood protein levels, allowing an assessment of causal direction from high blood protein levels to COVID-19 severity whilst avoiding influence of environmental effects,” he added. 

The scientists selected genetic variants, known as single nucleotide polymorphisms, that were strongly associated with blood protein levels. They then performed their analysis using Mendelian randomization to test the causal associations of those blood proteins with the development of severe COVID-19 infections.

“Mendelian randomization uses genetic variants associated with a trait [e.g., protein level] and measures their causal effect on disease outcomes, [avoiding] environmental confounding factors, such as lifestyle, being physically ill, etc.,” Alish Palmos, PhD, told Medical News Today. Palmos is a Postdoctoral Research Associate at King’s College London’s Social, Genetic, and Developmental Psychiatry Center and co-first author of the study.

Blood Groups Linked to COVID-19 Hospitalization, Death

One of the most important findings of the KCL research is a causal association between COVID-19 severity and an enzyme called ABO, which determines blood type. This discovery suggests that blood groups perform an instrumental role in whether individuals develop severe forms of the illness. 

“The enzyme helps determine the blood group of an individual and our study has linked it with both risk of hospitalization and the need of respiratory support or death,” said Christopher Hübel, PhD, Postdoctoral Research Associate, King’s College and co-last author of the study in the press release. “Our study does not link precise blood group with risk of severe COVID-19, but since previous research has found that proportion of people who are group A is higher in COVID-19 positive individuals, this suggests that blood group A is more likely candidate for follow-up studies.” 

The KCL researchers uncovered several compelling findings regarding blood proteins and COVID-19, including:

  • The discovery of six blood markers that were significantly associated with an elevated risk of hospitalization.
  • The discovery of nine blood markers that were significantly associated with a decreased risk of hospitalization.
  • Consistent results indicating hospitalization being significantly associated with decreased levels of macrophage inflammatory protein.
  • Five blood markers associated with the need for respiratory support or death.
  • Eight blood markers causally associated with a statistically significantly decreased risk of need for respiratory support or death.
  • Consistent results with respiratory support or death being significantly causally associated with decreased levels of neprilysin.

Developing New COVID-19 Treatments and Preventative Therapies

“What we have done in our study is provide a shortlist for the next stage of research,” said Gerome Breen, PhD, in the KCL news release. Breen is Professor of Psychiatric Genetics at King’s College London’s Institute of Psychiatry, Psychology and Neuroscience, and co-last author of the study.

“Out of 1000s of blood proteins we have whittled it down to about 14 that have some form of causal connection to the risk of severe COVID-19 and present a potentially important avenue for further research to better understand the mechanisms behind COVID-19 with an ultimate aim of developing new treatments but potentially also preventative therapies,” he added. 

Further research and clinical investigation are needed to validate the King’s College London researchers’ findings. However, their insights could result in new clinical laboratory tests and personalized treatments for COVID-19.

JP Schlingman

Related Information:

Genetic Study Reveals Causal Link Between Blood Type and COVID Severity

Proteome-wide Mendelian Randomization Identifies Causal Links Between Blood Proteins and Severe COVID-19

New Research Suggests a Causal Link Between Blood Group and Severe COVID-19

Researchers Identify Six Proteins Linked with Severe COVID-19

COVID: Risk of Severe Disease Could be in Your Blood, New Research Finds

COVID-19 Severity: Blood Group May Influence Risk

A Two Minute Primer on Mendelian Randomization

Researchers Find Health of Human Microbiome Greatly Influenced by Foods We Eat

One key finding of interest to clinical laboratory scientists is that this research study indicates that the human microbiome may more closely correlate with blood markers of metabolic disease than the genome of individuals

In the search for more sensitive diagnostic biomarkers (meaning the ability to detect disease with smaller samples and smaller quantities of the target biomarker), an international team of researchers has teased out a finding that a panel of multiple biomarkers in the human microbiome is more closely correlated with metabolic disease than genetic markers.

The team also discovered that the foods an individual ate had a more powerful impact on their microbiomes than their genes. The study participants included several sets of identical twins. The researchers found that identical twins shared only about 34% of the same gut microbes. People who were unrelated shared 30% of the same gut microbes.

This is a fascinating insight for pathologists and microbiologists involved in the study of the human microbiome for use in development of precision medicine clinical laboratory testing and drug therapies.

Microbiome Markers for Obesity, Heart Disease, and More

The study began in 2018, when an international team of researchers analyzed the gut microbiomes, diets, and blood biomarkers for cardiometabolic health obtained from 1,100 mostly healthy adults in the United Kingdom (UK) and the United States (US). They collected blood samples from the participants before and after meals to examine blood sugar levels, hormones, cholesterol, and inflammation levels. Sleep and activity levels also were monitored. Participants had to wear a continuous glucose monitor for two weeks during the research period.

The scientists discovered that the composition of a healthy gut microbiome is strongly linked to certain foods, food groups, nutrients, and diet composition. They identified markers for obesity, impaired glucose tolerance, and cardiovascular disease in the gut bacteria. 

“When you eat, you’re not just nourishing your body, you’re feeding the trillions of microbes that live inside your gut,” genetic epidemiologist Tim Spector, MD, FmedSCi, told Labroots. Spector is a professor of genetic epidemiology at King’s College London and one of the authors of the study.

The scientists found that a diet rich in nutrient-dense, whole foods was more beneficial to a healthy gut microbiome, which can be an indicator of good health. Individuals who ate minimally processed foods, such as vegetables, nuts, eggs, and seafood were more likely to have healthy gut bacteria than individuals who consumed large amounts of highly processed foods, like juices and other sweetened beverages, processed meats, and refined grains and foods that were high in added sugars and salt.

“It goes back to the age-old message of eating as many whole and unprocessed foods as possible,” Sarah Berry, PhD, a nutrition scientist at King’s College London and a co-author of the study told The New York Times. “What this research shows for the first time is the link between the quality of the food we’re eating, the quality of our microbiomes, and ultimately our health outcomes,” she added.

The researchers concluded that heavily processed foods tend to contain very minimal amounts of fiber, a macronutrient that helps promote good bacteria in the gut microbiome and leads to better metabolic and cardiovascular health.

They found that people who had healthy blood sugar levels following a meal had higher levels of good bacteria called Prevotella copri, a genus of gram-negative bacteria, and Blastocystis, a genus of single-celled heterokont parasites, present in their guts. These bacteria are associated with lower levels of visceral fat, which accumulates around internal organs and increases risk of heart disease.

These “good” microbes also are affiliated with lower levels of inflammation, better blood sugar control, and lower spikes in blood fat and cholesterol levels after meals.

Nicola Segata, PhD

“We were surprised to see such large, clear groups of what we informally call ‘good’ and ‘bad’ microbes emerging from our analysis,” Nicola Segata, PhD (above), told News Medical. Segata is a professor and principal investigator at the Computational Metagenomics Lab at the University of Trento in Italy, and co-author of the study. “It is also exciting to see that microbiologists know so little about many of these microbes that they are not even named yet. This is now a big area of focus for us, as we believe they may open new insights in the future into how we could use the gut microbiome as a modifiable target to improve human metabolism and health,” he added. Pathologists and clinical laboratory scientists who read Dark Daily are already familiar with the plethora of ways the human microbiome is being studied for use in diagnostic testing and drug therapy. (Photo copyright: University of Trento.)

The study also found that different people have wildly varying metabolic responses to the same foods, partially due to the types of bacteria residing in their gut microbiome. The consumption of some foods is better for overall health than other foods, but there is no definitive, one-size-fits-all diet that works for everyone.

“What we found in our study was that the same diet in two different individuals does not lead to the same microbiome, and it does not lead to the same metabolic response. There is a lot of variation,” Andrew Chan, MD, Professor of Medicine at Harvard Medical School, told The New York Times. Chan is also Chief of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital and co-author of the study.

Small Changes in Diet, Big Impact to Health

The team is now planning a clinical trial to test whether changes in diet can alter levels of good and bad microbes in the gut. If proven to be true, such information could help clinicians design personalized nutritional plans that would enable individuals to improve their gut microbiome and their overall health.

“As a nutritional scientist, finding novel microbes that are linked to specific foods, as well as metabolic health, is exciting,” Berry told News Medical. “Given the highly personalized composition of each individual’s microbiome, our research suggests that we may be able to modify our gut microbiome to optimize our health by choosing the best foods for our unique biology.

“We think there are lots of small changes that people can make that can have a big impact on their health that might be mediated through the microbiome,” Berry told The New York Times.

The researchers published their findings in Nature Medicine, titled, “Microbiome Connections with Host Metabolism and Habitual Diet from 1,098 Deeply Phenotyped Individuals.”

More research and clinical trials are needed before diagnostic tests that use microbiome biomarkers to detect metabolic diseases can be developed. But these early research findings are a sign to pathologists and clinical laboratory managers that microbiome-based assays may come to play a more significant role in the early detection of several metabolic diseases.

JP Schlingman

Related Information:

Connecting Gut Microbes, Diet, and Health

Study Uncovers Strong Links Between a Person’s Diet, Gut Microbes and Health

Microbiome Connections with Host Metabolism and Habitual Diet from 1,098 Deeply Phenotyped Individuals

How the Right Foods May Lead to a Healthier Gut, and Better Health

University of Utah and Sloan Kettering Institute Study Sheds Light on How the Body Recognizes “Good” from Bad Bacteria in the Microbiome

International Study into Ancient Poop Yields Insight into the Human Microbiome, May Produce Useful Insights for Microbiologists

Mayo Clinic Researchers Find Some Bacteria Derail Weight Loss, Suggest Analysis of Individuals’ Microbiomes; a Clinical Lab Test Could Help Millions Fight Obesity

King’s College London Study Identifies Six Distinct ‘Types’ of COVID-19 Illness, Each with a Distinct ‘Cluster’ of Symptoms

The KCL researchers’ new models for predicting which patients will need hospitalization and breathing support may be useful for pathologists and clinical laboratory scientists

One more window into understanding the SARS-CoV-2 coronavirus may have just opened. A British study identified six distinct “clusters” of symptoms that the research scientists believe may help predict which patients diagnosed with COVID-19 will require hospitalization and respiratory support. If further research confirms these early findings, pathologists and medical laboratory managers may gain new tools to diagnose infections faster and more accurately.

Researchers from King’s College London (KCL) analyzed data gathered from the COVID Symptom Study App, a mobile-device application developed by health science company ZOE in collaboration with scientists and physicians at KCL and Massachusetts General Hospital, as well as:

Launched in March in the United Kingdom and extended to the United States and Sweden, the app has attracted more than four million users who track their health and potential COVID symptoms on a daily basis.

Increased Accuracy in Predicting COVID-19 Hospitalizations

On July 17, 2020, the Centers for Disease Control and Prevention (CDC) published “Symptom Profiles of a Convenience Sample of Patients with COVID-19—United States, January–April 2020,” which identifies cough, fever, and shortness of breath as the most typical symptoms of COVID-19. However, the KCL study takes those findings a step further.

KCL researchers identified six distinct “types” of COVID-19, each distinguished by a particular cluster of symptoms. They include headaches, muscle pains, fatigue, diarrhea, confusion, loss of appetite, shortness of breath, and more. The researchers also found that COVID-19 disease progression and outcome also vary significantly between people, ranging from mild flu-like symptoms or a simple rash to severe or fatal conditions.

Using app data logged by 1,600 users in March and April, the researchers developed an algorithm that combined information on age, gender, body mass index (BMI), and pre-existing conditions with recorded symptoms from the onset of the illness through the first five days. The researchers then tested the algorithm using a second independent dataset of 1,000 users, logged in May.

In a news release, the KCL researchers identified the six clusters of symptoms as:

  • Flu-like with No Fever: Headache, loss of smell, muscle pains, cough, sore throat, chest pain, no fever.
  • Flu-like with Fever: Headache, loss of smell, cough, sore throat, hoarseness, fever, loss of appetite.
  • Gastrointestinal: Headache, loss of smell, loss of appetite, diarrhea, sore throat, chest pain, no cough.
  • Severe Level One, Fatigue: Headache, loss of smell, cough, fever, hoarseness, chest pain, fatigue.
  • Severe Level Two, Confusion: Headache, loss of smell, loss of appetite, cough, fever, hoarseness, sore throat, chest pain, fatigue, confusion, muscle pain.
  • Severe Level Three, Abdominal and Respiratory: Headache, loss of smell, loss of appetite, cough, fever, hoarseness, sore throat, chest pain, fatigue, confusion, muscle pain, shortness of breath, diarrhea, abdominal pain.

Using the data, the researchers were able to more accurately predict—78.8% versus 69.5%—which of the six symptom clusters placed patients at higher risk of requiring hospitalization and breathing support (ventilation or additional oxygen) than with prediction models based on personal characteristics alone. For example, nearly 50% of the patients in cluster six (Severe Level Three, Abdominal and Respiratory) ended up in the hospital, compared with 16% of those in cluster one (Flu-like with No Fever).

Claire Steves, MD, PhD a Clinical Senior Lecturer at King’s College London
“These findings have important implications for care and monitoring of people who are most vulnerable to severe COVID-19,” Claire Steves, MD, PhD (above left), Clinical Senior Lecturer at King’s College London, said in the KCL news release. “If you can predict who these people are at day five, you have time to give them support and early interventions, such as monitoring blood oxygen and sugar levels, and ensuring they are properly hydrated—simple care that could be given at home, preventing hospitalizations and saving lives.” (Photo copyright: King’s College London.)

According to the Zoe website, the ongoing research is led by:

The researchers published their study findings at medRxiv, titled, “Symptom Clusters in COVID-19: A Potential Clinical Prediction Tool from the COVID Symptom Study App.” The study has not yet undergone peer review.

Encouraging Everyone to Use the COVID-Symptom Study App

The study points out that—broadly speaking—people with cluster four, five, or six COVID-19 symptoms tended to be older and frailer and were more likely to be overweight and have pre-existing conditions, such as diabetes or lung disease, than those with cluster one, two, or three symptoms.

Carole Sudre, PhD a research fellow at King's College London
“Our study illustrates the importance of monitoring symptoms over time to make our predictions about individual risk and outcomes more sophisticated and accurate,” said lead researcher Carole Sudre, PhD (above), a Research Fellow at King’s College London and the study’s lead researcher, in the KCL news release. “This approach is helping us to understand the unfolding story of this disease in each patient so they can get the best care.” (Photo copyright: University College London.)

Tim Spector, FMedSci, Head of the Department of Twin Research and Genetic Epidemiology, and Professor of Genetic Epidemiology at King’s College London, encourages everyone to download the COVID Symptom Study app and help increase the data available to researchers.

“Data is our most powerful tool in the fight against COVID-19,” Spector said in the KCL news release. “We urge everyone to get in the habit of using the app daily to log their health over the coming months, helping us to stay ahead of any local hotspots or a second wave of infections.”

As the body of knowledge surrounding COVID-19 grows, clinical laboratory professionals would be well advised to remain informed on further research regarding not only the potential for COVID-19 variants to exist, but also the evolving guidance on infection prevention and testing.

—Andrea Downing Peck

Related Information:

Six Distinct ‘Types’ of COVID-19 Identified

Symptom Clusters in COVID19: A Potential Clinical Prediction Tool from the COVID Symptom Study App

Symptom Profile of a Convenience Sample of Patients with COVID-19–United States, January-April 2020

Clinical Laboratory Test for Alzheimer’s Disease Gets Ever Closer to Reality

Scientists worldwide engaged in research to develop a biomarker for dementia are predicting success, though some say additional research will be needed

Could a blood test for Alzheimer’s disease soon be on clinical laboratory test menus nationwide? Perhaps so. A recent Associated Press (AP) article that was picked up by NBC News and other healthcare publications reported that experimental test results presented during the Alzheimer’s Association International Conference (AAIC) in July suggest the Holy Grail of dementia tests—one where the specimen can be collected in a doctor’s office during a routine screening exam—may be close at hand.

The AP story noted that “half a dozen research groups gave new results on various experimental tests, including one that seems 88% accurate at indicating Alzheimer’s risk.” And Richard Hodes, MD, Director of the National Institute on Aging, told AP, “In the past year, we’ve seen a dramatic acceleration in progress [on Alzheimer’s tests]. This has happened at a pace that is far faster than any of us would have expected.”

This could be a boon for medical laboratories seeking way to contribute more value to patient care. Especially among Alzheimer’s patients, who account for as many as 70% of all dementia cases.

Plasma Biomarker for Predicting Alzheimer’s

One of the experimental blood tests presented at the AAIC involved a 2018 study into “the potential clinical utility of plasma biomarkers in predicting brain amyloid-β burden at an individual level. These plasma biomarkers also have cost-benefit and scalability advantages over current techniques, potentially enabling broader clinical access and efficient population screening,” the researchers stated an article they published in Nature.

Dark Daily reported on this study in “Researchers in Two Countries Develop Blood Tests That Detect Alzheimer’s Decades Before Symptoms Appear; Could Eventually Give Clinical Laboratories a Diagnostic Tool,” June 4, 2018. The test “measures abnormal versions of the protein [amyloid beta] that forms the plaques in the brain that are the hallmark of Alzheimer’s,” the AP story reported.

AP also reported that Japanese scientists at the AAIC presented results of a validation test conducted on 201 people who had either Alzheimer’s, other types of dementia, or little or no symptoms. They found that the test “correctly identified 92% of people who had Alzheimer’s and correctly ruled out 85% who did not have it, for an overall accuracy of 88%.”

Akinori Nakamura, MD, PhD, of the National Center for Geriatrics and Gerontology in Obu, Japan, was a member of the research team and first author of the research paper. He told the AP that the test results “closely matched those from the top tests used now—three types of brain scans and a mental assessment exam.”

Eric McDade, DO (above), Associate Professor of Neurology at Washington University in St. Louis, told Neurology Today, “The results reported here provide a relatively high level of confidence given that this is a relatively well characterized population with an amyloid PET scan to provide confirmation of a significant level of amyloid plaque burden in the brain.” Could this level of physician confidence lead to a clinical laboratory test based on the plasma biomarker? (Photo copyright: Washington University.)

Koichi Tanaka is a Japanese engineer who won the Nobel prize winner for chemistry. He heads the Koichi Tanaka Research Lab at Shimadzu Corp. (OTCMKTS:SHMZF) in Kyoto, Japan, and was on the team that developed the Amyloid beta biomarker test that was presented at AAIC. He told Bloomberg, “Our finding overturned the common belief that it wouldn’t be possible to estimate amyloid accumulation in the brain from blood. We’re now being chased by others, and the competition is intensifying.”

But Tanaka cautions that the test needs further study before it is ready for clinical use, and that for now “it belongs in the hands of drug developers and research laboratories,” Bloomberg reported.

Other Studies into Developing an Alzheimer’s Biomarker

Alzheimer’s is usually diagnosed after symptoms appear, such as memory loss. To arrive at their diagnoses, doctors often rely on medical history, brain imaging (MRI, CT), PET, and measurement of amyloid in spinal fluid.  

An article published on Alzforum, a website and news service dedicated to the research and treatment for Alzheimer’s and other related disorders, noted a study by King’s College London researchers who, using mass spectrometry, “found a panel of biomarkers that predicted with almost 90% accuracy whether cognitively normal people had a positive amyloid scan.”

Nicholas Ashton, PhD, neuroscientist and Wallenberg Postdoctoral Fellow at University of Gothenburg in Sweden, and first author of the King’s College study, explained that “Amyloid-burden and neurofilament light polypeptide (NFL) peptides were important in predicting Alzheimer’s, but alone they weren’t as predictable as when we combined them with novel proteins related to amyloid PET.”

The researchers published their study earlier this year in Science Advances. “Using an unbiased mass spectrometry approach, we have found and replicated with high accuracy, specificity, and sensitivity a plasma protein classifier reflecting amyloid-beta burden in a cognitively unimpaired cohort,” the researchers wrote.

Meanwhile, researchers at Washington University School of Medicine St. Louis, along with the German Center for Neurodegenerative Diseases, a member of the Helmholtz Association, stated in a news release that a blood test they developed works by detecting leaks of NFL before the onset of symptoms. When the protein is found in cerebrospinal fluid, it could be a sign that Alzheimer’s may develop, as well as point to other neurodegenerative conditions such as multiple sclerosis, brain injury, or stroke, the researchers stated.  

“This is something that would be easy to incorporate into a screening test in a neurology clinic,” Brian Gordon, PhD, Assistant Professor of Radiology at Washington University’s Mallinckrodt Institute of Radiology, and an author of the study, stated in the news release.

These parallel studies into screening for Alzheimer’s by researchers worldwide are intriguing. The favorable results suggest that someday there may be a screen for Alzheimer’s using a clinical laboratory blood test.

With Alzheimer’s affecting nearly six million Americans of all ages, such an assay would enable clinical laboratories to help many people.

—Donna Marie Pocius

Related Information:

Scientists Close in On Blood Test for Alzheimer’s

Advances in the Global Search for Blood Markers for Alzheimer’s Disease and Other Dementias

A Blood Test Can Predict Dementia. Trouble Is, There’s No Cure

Plasma Biomarker for Amyloid Correlates with Alzheimer’s Progression, Study Finds

High Performance Plasma Amyloid-β Biomarkers for Alzheimer’s Disease

Panel Blood Markers Signals Amyloid in Brain

A Plasma Protein Classifier for Predicting Amyloid Burden for Preclinical Alzheimer’s Disease

Blood Test Detects Alzheimer’s Damage Before Symptoms; Test Also May Identify Neurodegeneration in Other Brain Diseases

Blood-Brain Barrier Breakdown is an Early Biomarker of Human Cognitive Dysfunction

Researchers in Two Countries Develop Blood Tests That Detect Alzheimer’s Decades Before Symptoms Appear Could Eventually Give Clinical Laboratories A Diagnostic Tool

UK’s NHS to Distribute New Clinical Laboratory Test for Women Suspected of Having Pre-Eclampsia

Based on clinical trials of the medical laboratory test, pregnant women can expect a reduced risk for experiencing complications associated with the dangerous blood disorder

Clinical pathology laboratories and obstetricians in the UK may soon have a new blood test that can help provide earlier diagnoses of pre-eclampsia, a hypertensive disorder of pregnancy that can cause liver and kidney disfunctions and, if untreated, can lead to eclampsia and deadly seizures.

Following a clinical trial conducted by scientists at King’s College London (King’s College), the National Health Service (NHS) in the United Kingdom (UK) announced it would be making the new test widely available.

The researchers published their findings in The Lancet medical journal. Their paper explains that the clinical trial took place in 11 maternity units in the UK from June 2016 through October 2017. And that 1,023 women were divided into two groups:

  • 576 (56%) were in the “intervention group,” meaning they had PGF test results made available to their maternity teams;
  • 447 (44%) did not have PGF test results made available.

The researchers, the Independent reported, wanted to determine the impact, if any, the new test’s results would have on diagnoses.

Significantly Reduced Time to Diagnosis

Trial results indicated that measuring the placental growth factor (PGF) in women who are suspected of having pre-eclampsia can increase speed to diagnosis. “PGF testing was shown to reduce the average time to pre-eclampsia diagnosis from 4.1 days to 1.9 days, and serious complications before birth (such as eclampsia, stroke, and maternal death) [dropped] from 5% to 4%,” a King’s College press release stated.

“Complications like stroke, seizures and maternal death fell by 20% when doctors had access to PGF testing,” the Independent reported.

The researchers stated in their study, “Our trial has shown that, in women presenting with suspected pre-eclampsia, PGF measurement, incorporated into a management algorithm based on national guidelines, significantly reduces the time taken for treating clinicians to diagnose pre-eclampsia. This improvement was associated with a significant reduction in maternal adverse outcomes, with no detected difference in gestational age at delivery or adverse perinatal outcomes.”

The King’s College press release states, “Pre-eclampsia is suspected in around 10% of UK pregnancies, affecting approximately 80,000 women annually. If untreated, it can progress to cause complications in the woman, including damage to vital organs, fits, and can be fatal for the woman and baby. Globally, 100 women die as a result of the condition every day.”

The release also noted that “doctors were able to diagnose pre-eclampsia on average two days sooner. This was associated with significant improvements in outcomes for women without causing health problems for babies.”

Tony Young, PhD (above), National Clinical Lead for Innovation at NHS, stated in the King’s College press release that “This innovative blood test helps determine the risks of pre-eclampsia in pregnancy, enabling women to be directed to appropriate care or reduce unnecessary worry more quickly.” (Photo copyright: LinkedIn.)

Measuring PGF in Clinical Laboratory Study

PGF is a molecular marker for inflammation associated mostly with the mother’s placenta. The King’s College researchers wanted to find out if a quicker diagnosis of pre-eclampsia was possible. And, if so, could it reduce adverse outcomes in the mother and baby?

“For the last hundred years, we have diagnosed pre-eclampsia through measuring blood pressure and checking for protein in a woman’s urine. These are relatively imprecise and often quite subjective,” said Lucy Chappell, PhD, NIHR Research Professor in Obstetrics at King’s College, and lead author of the study, in the news release.

“We knew that monitoring PGF was an accurate way to help detect the condition, but [we] were unsure whether making this tool available to clinicians would lead to better care for women. Now we know that it does,” she concluded.

Pre-eclampsia can lead to stroke, seizures, and even death of expectant mothers and unborn children. It is usually diagnosed after 20 weeks of gestation through blood pressure tests and urine tests that show hypertension and elevated protein levels.

“We found that the availability of PGF test results substantially reduced the time to clinical confirmation of pre-eclampsia. Where PGF was implemented, we found a lower incidence of maternal adverse outcomes,” the researchers wrote in their study.

Similar Study in the US

In the UK, pre-eclampsia affects about one in 20 pregnancies or 80,000 women each year, New Scientist explained. While in the US, data compiled from the Centers for Disease Control and Prevention (CDC) indicate that pre-eclampsia affects one in 25 pregnancies or about 154,220 women annually.

Researchers in Ohio also recently reported on a test and a piloted clinical study for rapid diagnosis of pre-eclampsia.

Scientists at Ohio State University’s College of Medicine and Wexner Medical Center (OSU), and at Nationwide Children’s Hospital, have developed a non-invasive red-dye-on-paper urine test to identify pre-eclampsia at the point-of-care, a Wexner press release announced.

“This is the first clinical study using the point-of-care, paper-based Congo Red Dot (CRD) diagnostic test, and the mechanism proved superior in establishing or ruling out a diagnosis of pre-eclampsia,” Kara Rood, MD, a maternal-fetal medicine physician at Wexner Medical Center and first author of the study said in the Wexner press release. “Our findings will have a huge impact on the health of women and children.”

The researchers published their findings in EClinicalMedicine, a Lancet Journal.

“Pre-eclampsia is often described as ‘mysterious’ because it’s difficult to diagnose. Our researchers show that there’s an easy, non-invasive test that will help diagnose this condition and maintain the health of pregnant women and their babies,” K. Craig Kent, MD, OSU Dean of the College of Medicine, said in the press release.

Clinical laboratory tests such as these being developed in the US and abroad could help pregnant women worldwide experience happy pregnancies and give birth to healthy babies. Medical laboratory leaders in this country may want to stay abreast of the development of these simple blood and urine tests.

                                                                        —Donna Marie Pocius

Related Information:

Pre-Eclampsia: NHS to Roll Out Breakthrough Test Which Speeds Up Diagnosis and Can Save Lives

Blood Test Helps Accurate, Rapid Diagnosis for Pre-eclampsia

Blood Pressure in Pregnancy

Placental Growth Factor Testing to Assess Women with Suspected Pre-eclampsia: a Multi-Centre, Pragmatic, Stepped-wedge Cluster Randomized Controlled Trial

Pre-Eclampsia Blood Test Could Help Diagnose the Condition Earlier

Research Finds Simple Urine Test Allows for Rapid Diagnosis of Pre-eclampsia