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Clinical Laboratories and Pathology Groups

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Pathology Laboratory Cuts Lead to Worker Walkout in Australia

Underfunding of clinical laboratories has led to similar worker walkouts in multiple Australasian nations

Once again, cuts in government spending on pathology services has forced healthcare workers to walk off the job in Australia. This is in line with other pathology doctor and clinical laboratory workers strikes in New Zealand and other Australasian nations over the past few years.

Announcement of a planned closure of the pathology laboratory at 30-bed Cootamundra Hospital in Australia to make room for expanding the emergency department spurred the health worker walkouts.

“Health staff from Cootamundra Hospital, alongside pathology workers from Deniliquin, Tumut, Griffith, Wagga Wagga, and Young will rally in front of their respective facilities” to draw attention to the effect closing the lab would have on critical healthcare services across those areas, Region Riverina reported.

The strikes are drawing attention to unfair pay and poor working conditions that underfunding has brought to the state-run healthcare systems in those nations. They also highlight how clinical laboratories worldwide are similarly struggling with facility closings, unfair pay, and unachievable workloads.

“The proposed closure of Cootamundra’s pathology lab is a short-sighted decision that will have far-reaching consequences for patient care in the region,” NSW Health Services Union (HSU) Secretary Gerard Hayes (above) told Region Riverina. Similar arguments have been made for years concerning the underfunding, pay disparities, and poor working conditions in New Zealand’s government-run clinical laboratories and pathology practices that has led to worker strikes there as well. (Photo copyright: HSU.)

Australia Pathology Lab Closure Stokes Fears

Cootamundra Hospital’s strike was spurred by a planned closure of its pathology laboratory. In May, employees learned of the plans to close the lab as well as surgery and birthing centers to accommodate expansion of the emergency department, Region Riverina reported.

“Pathology workers are already in short supply and this move could see us lose highly skilled professionals from the NSW Health system altogether,” New South Wales (NSW) Health Services Union (HSU) Secretary Gerard Hayes told Region Riverina.

The cuts would not only be detrimental to the area, it would significantly affect patient care, he added.

“This lab is not just profitable; it’s a vital lifeline for Cootamundra Hospital’s [surgical] theater lists and maternity unit,” he said. “Without this lab, patients will face significantly longer wait times for life-saving diagnostic information. This delay could severely impact our ability to provide timely care, especially in emergencies.”

Echoing those sentiments, HSU Union Official Sam Oram told Region Riverina that closing the Cootamundra Hospital lab would put pressure on labs in Wagga and Young and would continue a trend of closing smaller pathology labs. Oram, who organizes for members in Canberra and Murrumbidgee Local Health District, noted that smaller labs in Tumut and Deniliquin could be in danger as well.

“Why should people living in rural and regional areas have fewer and inferior services to Australians living in metropolitan areas?” Michael McCormack, MP, Federal Member for Riverina and former deputy prime minister of Australia, asked Parliament in June, Region Riverina reported. “There’s no right or proper answer to that question. They simply should not,” he added.

Tasmania’s Troubles

Medical scientists recently walked off the job at Launceston General Hospital in Tasmania, Australia, to protest “the government’s ‘inaction’ on recruiting more staff,” according to Pulse Tasmania. The hospital’s lab has a staff shortage of 17 employees, requiring the remaining staff members to handle a much increased workload, Ryan Taylor, a medical laboratory scientist with the Tasmanian Department of Health, told Pulse Tasmania.

“This shortfall is leading to significant and unacceptable challenges … which are causing the Tasmanian community from receiving vital test results that are essential for their health,” Lucas Digney, Industrial Champion, Health and Community Services Union (HACSU) leader, told Pulse Tasmania.

New Zealand Struggles with Its Healthcare Workers

Aotearoa, as New Zealand is known by its indigenous Polynesian population, also struggles with health worker walkouts.

“Medical labs are an essential organ of the health system. Many were stupidly privatized years ago, others still operate within Te Whatu Ora [aka Health New Zealand, the publicly funded healthcare system] with all the resource shortages and stress that go with that,” Newsroom said of the country’s plight in 2023. “There was a view that competition in medical labs would produce greater efficiency, but it has actually produced a mess.”

Dark Daily has covered the ongoing strife in New Zealand’s clinical laboratories over many years. Previous ebriefs highlighted how the strikes were causing delays in critical clinical laboratory blood testing and surgical procedures.

In “New Zealand Blood Service Workers and Junior Doctors Hit the Picket Line Once Again to Fight against Pay Disparities and Poor Working Conditions,” we covered how after seven months of failed negotiations, New Zealand’s blood workers, clinical laboratory technicians, and medical scientists, again went on strike in May with another walkout planned for June.

In “Medical Laboratory Workers Again on Strike at Large Clinical Laboratory Company Locations around New Zealand,” we reported on a medical laboratory worker strike in New Zealand’s South Island and Wellington regions where workers walked off the job after a negotiated agreement was not reached between specialist union APEX and Awanui Labs, one of the country’s largest hospital and clinical laboratory services providers.

And in “Four Thousand New Zealand Medical Laboratory Scientists and Technicians Threatened to Strike over Low Pay and Poor Working Conditions,” we covered walkouts in 2022 sparked by an unprecedented surge in PCR COVID-19 testing that pushed the country’s 10,000 healthcare workers—including 4,000 medical laboratory scientists and technicians—to the breaking point.

Underfunding in clinical laboratories continues to cause work stoppages in the Australasian countries. But as Dark Daily readers know, it is a growing problem among European nations and in the United States as well.

—Kristin Althea O’Connor

Related Information:

NZ’s Health Lab Staff Deserve Better than Failed Private Leadership

Stop-Work Action Planned by Health Workers to Protest Pathology Lab Cuts

‘It’s Simply Not Good Enough’: McCormack Slams Planned Cuts to Cootamundra Hospital Maternity Services

Launceston General Hospital Medical Science Staff Walk Out over ‘Critical Understaffing Issues’

Pathologists Fear Sector Collapse without Urgent Change

Awanui Lab Workers Head Back to Bargaining Table

Lab Workers Go for Pay Parity

Mayo Clinic Scientists Develop AI Tool That Can Determine If Gut Microbiome is Healthy

Although it is a non-specific procedure that does not identify specific health conditions, it could lead to new biomarkers that clinical laboratories could use for predictive healthcare

Researchers from the Mayo Clinic recently used artificial intelligence (AI) to develop a predictive computational tool that analyzes an individual’s gut microbiome to identify how a person may experience improvement or deterioration in health. 

Dubbed the Gut Microbiome Wellness Index 2 (GMWI2), Mayo’s new tool does not identify the presence of specific health conditions but can detect even minor changes in overall gut health.

Built on an earlier prototype, GMWI2 “demonstrated at least 80% accuracy in differentiating healthy individuals from those with any disease,” according to a Mayo news release. “The researchers used bioinformatics and machine learning methods to analyze gut microbiome profiles in stool samples gathered from 54 published studies spanning 26 countries and six continents. This approach produced a diverse and comprehensive dataset.”

The Mayo researchers published their findings in the journal Nature Communications titled, “Gut Microbiome Wellness Index 2 Enhances Health Status Prediction from Gut Microbiome Taxonomic Profiles.”

“Finally, we have a standardized index to quantitatively measure how ‘healthy’ a person’s gut microbiome is,” said Jaeyun Sung, PhD, a computational biologist at the Mayo Clinic Center for Individualized Medicine: Microbiomics Program and senior author of the study in the news release.

“Our tool is not intended to diagnose specific diseases but rather to serve as a proactive health indicator,” said senior study author Jaeyun Sung, PhD (above), a computational biologist at the Mayo Clinic Center for Individualized Medicine: Microbiomics Program in the news release ease. “By identifying adverse changes in gut health before serious symptoms arise, the tool could potentially inform dietary or lifestyle modifications to prevent mild issues from escalating into more severe health conditions, or prompt further diagnostic testing.” For microbiologists and clinical laboratory managers, this area of new knowledge about the human microbiome may lead to multiplex diagnostic assays. (Photo copyright: Mayo Clinic.)

Connecting Specific Diseases with Gut Microbiome

Gut bacteria that resides in the gastrointestinal tract consists of trillions of microbes that help regulate various bodily functions and may provide insights regarding the overall health of an individual. An imbalance in the gut microbiome is associated with an assortment of illnesses and chronic diseases, including cardiovascular issues, digestive problems, and some cancers and autoimmune diseases

To develop GMWI2, the Mayo scientists provided the machine-learning algorithm with data on microbes found in stool samples from approximately 8,000 people collected from 54 published studies. They looked for the presence of 11 diseases, including colorectal cancer and inflammatory bowel disease (IBS). About 5,500 of the subjects had been previously diagnosed with one of the 11 diseases, and the remaining people did not have a diagnosis of the conditions. 

The scientists then tested the efficacy of GMWI2 on an additional 1,140 stool samples from individuals who were diagnosed with conditions such as pancreatic cancer and Parkinson’s disease, compared with those who did not have those illnesses.

The algorithm gives subjects a score between -6 and +6. People with a higher GMWI2 score have a healthier microbiome that more closely resembles individuals who do not have certain diseases.

Likewise, a low GMWI2 score suggests the individual has a gut microbiome that is similar to those who have specific illnesses. 

Highly Accurate Results

According to their study, the researchers determined that “GMWI2 achieves a cross-validation balanced accuracy of 80% in distinguishing healthy (no disease) from non-healthy (diseased) individuals and surpasses 90% accuracy for samples with higher confidence,” they wrote in Nature Communications.

Launched in 2020, the original GMWI (Gut Microbiome Wellness Index) was trained on a much smaller number of samples but still showed similar results. 

The researchers tested the enhanced GMWI2 algorithm across various clinical schemes to determine if the results were similar. These scenarios included individuals who had previous fecal microbiota transplants and people who had made dietary changes or who had exposure to antibiotics. They found that their improved tool detected changes in gut health in those scenarios as well.

“By being able to answer whether a person’s gut is healthy or trending toward a diseased state, we ultimately aim to empower individuals to take proactive steps in managing their own health,” Sung said in the news release.

The Mayo Clinic team is developing the next version of their tool, which will be known as the Gut Microbiome Wellness Index 3. They plan to train it on at least 12,000 stool samples and use more sophisticated algorithms to decipher the data.

More research and studies are needed to determine the overall usefulness of Mayo’s Gut Microbiome Wellness Index and its marketability. Here is a world-class health institution disclosing a pathway/tool that analyzes the human microbiome to identify how an individual may be experiencing either an improvement in health or a deterioration in health.

The developers believe it will eventually help physicians determine how patients’ conditions are improving or worsening by comparing the patients’ microbiomes to the profiles of other healthy and unhealthy microbiomes. As this happens, it would create a new opportunity for clinical laboratories to perform the studies on the microbiomes of patients being assayed in this way by their physicians.  

—JP Schlingman

Related Information:

Mayo Researchers Develop Tool That Measures Health of a Person’s Gut Microbiome

Gut Microbiome Wellness Index 2 Enhances Health Status Prediction from Gut Microbiome Taxonomic Profiles

Stanford University Scientists Discover New Lifeform Residing in Human Microbiome

Researchers Use Ingestible Device to Non-Invasively Sample Human Gut Bacteria in a Development That Could Enable More Clinical Laboratory Testing of Microbiomes

Researchers from Stanford University Develop First Synthetic Human Microbiome from Scratch

100-Biomarker Lab Test for Alzheimer’s Disease Developed by Team at University of Pittsburgh

New clinical laboratory test could replace conventional spinal tap for diagnosing neurodegenerative disease

In a proof-of-concept study, University of Pittsburgh (Pitt) scientists validated a clinical laboratory test that measures more than 100 different genetic sequences associated with Alzheimer’s disease. The Pitt researchers believe the new diagnostic platform could help clinicians “capture the multifaceted nature of Alzheimer’s pathology and streamline early disease diagnostics,” according to a news release.

Clinical laboratory blood tests that detect biomarkers such as phosphorylated tau protein (pTau) have emerged in studies as diagnostic possibilities for Alzheimer’s disease, which is traditionally diagnosed using a lumbar puncture (spinal tap) procedure.

The Pitt scientists published the findings of their study titled, “Multi-Analyte Proteomic Analysis Identifies Blood-based Neuroinflammation, Cerebrovascular, and Synaptic Biomarkers in Preclinical Alzheimer’s Disease,” in the journal Molecular Neurodegeneration.

In their paper, neuroscientist Thomas Karikari, PhD, Assistant Professor of Psychiatry at  University of Pittsburgh, lead author of the study, and his research team acknowledged that progress has been made in detecting Alzheimer’s disease with blood-based biomarkers. However, they note that “two key obstacles remain: the lack of methods for multi-analyte assessments and the need for biomarkers for related pathophysiological processes like neuroinflammation, vascular, and synaptic dysfunction.”

The Pitt scientists believe the focus on so-called “classical Alzheimer’s blood biomarkers” limits exploration of neurodegenerative disease.

“Alzheimer’s disease should not be looked at through one single lens. Capturing aspects of Alzheimer’s pathology in a panel of clinically validated biomarkers would increase the likelihood of stopping the disease before any cognitive symptoms emerge,” said neuroscientist Thomas Karikari, PhD (above), Assistant Professor of Psychiatry, University of Pittsburgh, and lead author of the study in a news release. Should further studies prove Pitt’s research sound, clinical laboratories may have a replacement test for diagnosing neurodegenerative disease. (Photo copyright: University of Pittsburgh.)

120 Proteins Analyzed Simultaneously

To conduct their research, the Pitt scientists performed a proof-of-concept study on 176 blood samples from 113 adults in Pennsylvania (average age of 76.7). They analyzed the blood using the NULISAseq CNS (central nervous system) Disease Panel 120 by Alamar Biosciences of Freemont, California.

On its website, Alamar Biosciences explains that the disease panel offers neurological researchers:

  • “Multiplexed analysis of 120 neuro-specific and inflammatory proteins from 10 µl of plasma or CSF (cerebrospinal fluid).
  • Detection of “critical biomarkers—including pTau-217, GFAP (glial fibrillary acidic protein), NEFL (neurofilament light polypeptide) and alpha-synuclein.”

The NULISAseq test works with “a proprietary sequential immunocomplex capture and release mechanism and the latest advances in next-generation sequencing,” according to the company.

Inside Precision Medicine noted that the Alamar Biosciences assay enabled Pitt scientists to detect:

  • Biomarkers (usually found in CSF) “correlating with patients’ amyloid positivity status and changes in amyloid burden over time,” and,
  • Biomarkers including “neuroinflammation, synaptic function, and vascular health, which had not previously been validated in blood samples.”

“The performance of the NULISA platform was independently validated against conventional assays for classic Alzheimer’s biomarkers for each sample. Biomarker profiles over two years were also compared with imaging-based measures of amyloid, tau, and neurodegeneration,” LabMedica reported.

Opportunity to Track Alzheimer’s

Karikari sees the diagnostic platform being used to track individuals’ blood biomarker changes over time. 

In their Molecular Neurodegeneration paper, the Pitt researchers wrote, “These (results) were not limited to markers such as pTau217, p-Tau231, p-Tau181, and GFAP, the elevation of which have consistently shown strong associations with brain Aβ [amyloid beta] and/or tau load, but included novel protein targets that inform about the disease state of the individual in different pathological stages across the biological Alzheimer’s disease continuum.”

About seven million Americans are affected by Alzheimer’s disease, according to the Alzheimer’s Association, which estimated that figure will grow to 13 billion by 2050.

Further studies by Karikari may include larger samples and greater diversity among the people studied, Inside Precision Medicine noted.

“[Karikari’s] lab is developing a predictive model that correlates biomarker changes detected using NULISAseq with brain autopsy data and cognitive assessments collected over the course of several years. Their goal is to identify blood biomarkers that can help stage the disease and predict its progression, both for decision-making around clinical management and treatment plans,” the Pitt news release states.

His research was supported by the National Institute on Aging.

The Pitt scientists have developed a multiplex test that works with 100 different genetic sequences associated with Alzheimer’s. Such advances in the understanding of the human genome are giving scientists the opportunity to combine newly identified gene sequences that have a role in specific disease states.

In turn, as further studies validate the value of these biomarkers for diagnosing disease and guiding treatment decisions, clinical laboratories will have new assays that deliver more value to referring physicians and their patients.

—Donna Marie Pocius

Related Information:

Pitt Scientists Validated a New Panel for Blood Biomarkers of Alzheimer’s

Multi-Analyte Proteomic Analysis Identifies Blood-based Neuroinflammation, Cerebrovascular, and Synaptic Biomarkers in Preclinical Alzheimer’s Disease

Innovative Blood Test Validated for Comprehensive Early Alzheimer’s Diagnosis

New Blood Test Platform Simultaneously Measures Over 100 Biomarkers of Alzheimer’s Disease

Cerebrospinal Fluid and Plasma Tau as a Biomarker for Brain Tauopathy

University of Colorado Boulder Scientists Demonstrate Acoustic-based Diagnostic System

Small handheld device uses sound waves to detect certain clinical laboratory biomarkers in blood samples

University of Colorado Boulder researchers have developed a novel technology that uses sound waves to test for biomarkers in blood samples. In addition to being very easy to use, the handheld device is portable, highly sensitive, and delivers results in minutes. Though not ready for clinical use, this is yet another example of how researchers are developing faster diagnostic tests that can be performed in near-patient settings, and which do not have to be done in core laboratories, shortening time to answer.

The small instrument—referred to as an “acoustic pipette”—delivers sound waves to tiny particles within the device called “functional negative acoustic contrast particles” (fNACPs). These particles are cell-sized balls that can be customized with different coatings to identify specific biomarkers—such as viruses or proteins—in tiny blood samples, according to a news release.

To operate the device, the custom fNACPs are mixed with a drop of blood and then placed inside the acoustic pipette. The mixture is then blasted with sound waves, which forces particles carrying certain biomarkers to one side of the chamber where they are trapped while the rest of the blood is expelled. The captured biomarkers are then labeled with fluorescent tags and examined with lasers to determine how much of a specific biomarker is present. 

The researchers published their findings in the journal Science Advances titled, “Acoustic Pipette and Biofunctional Elastomeric Microparticle System for Rapid Picomolar-Level Biomolecule Detection in Whole Blood.”

“We’re basically using sound waves to manipulate particles to rapidly isolate them from a really small volume of fluid,” said Cooper Thome (above), PhD candidate in Chemical and Biological Engineering at UC Boulder and first author of the study in a news release. “It’s a whole new way of measuring blood biomarkers,” he added. Should further studies validate this approach, clinical laboratories may be able to use this technology to perform diagnostic tests with smaller volumes of patient samples. (Photo copyright: University of Colorado Boulder.)

Blood Testing Quickly and in Multiple Settings

To test their invention, the UC Boulder researchers examined antibodies against a protein called ovalbumin, which is found in egg whites and often used in the development of various vaccines. The scientists discovered that their device could detect the antibodies even in low amounts. 

Current rapid tests known as lateral-flow assays can detect specific biomarkers in blood or urine samples but cannot determine how much of the biomarker is present. Enzyme-linked immunotherapy assays (ELISA), the leading clinical laboratory blood test, requires expensive equipment and can take hours to days for results to be received. 

With UC Boulder’s new handheld device, tiny blood samples collected from a single finger prick could ensure accurate test results are available quickly at the point of care as well as outside of traditional healthcare settings. This would greatly benefit people in developing nations and underserved communities and may help ease test anxiety for individuals who are apprehensive about traditional blood tests. 

“We’ve developed a technology that is very user friendly, can be deployed in various settings, and provides valuable diagnostic information in a short time frame,” said Wyatt Shields IV, PhD, Assistant Professor, Department of Chemical and Biological Engineering, UC Boulder, and senior author of the research in the news release.

“In our paper, we demonstrate that this pipette and particle system can offer the same sensitivity and specificity as a gold-standard clinical test can but within an instrument which radically simplifies workflows,” he added. “It gives us the potential to perform blood diagnostics right at the patient’s bedside.”

The graphic above, taken from UC Boulder’s published paper, illustrates how “fNACPs capture target biomarkers from whole blood samples. fNACPs are purified from blood components by acoustic trapping and captured biomarkers are labeled with a fluorescent antibody within the acoustic pipette. fNACP fluorescence is then measured to determine biomarker presence and concentration.” (Graphic/caption copyright: University of Colorado Boulder.)

Not Like Theranos

The authors of the UC Boulder study are cognizant of some skepticism surrounding the field of biosensing, especially after the downfall of Theranos. The scientists insist their technology is different and based on systematic experiments and peer-reviewed research.

“While what they (Theranos) claimed to do isn’t possible right now, a lot of researchers are hoping something similar will be possible one day,” said Thome in the news release. “This work could be a step toward that goal—but one that is backed by science that anybody can access.”

The device is still in its initial proof-of-concept stage, but the UC Boulder scientists have applied for patents for the apparatus and are searching for ways to scale its use and expand its capabilities.

“We think this has a lot of potential to address some of the longstanding challenges that have come from having to take a blood sample from a patient, haul it off to a lab, and wait to get results back,” Shields noted.

More research, studies, and regulatory reviews will be needed before this technology becomes available for regular, widespread use. But UC Boulder’s new blood testing device is another example of a research team using novel technology to test for known biomarkers in ways that could improve standard clinical laboratory testing. 

—JP Schlingman

Related Information:

Acoustic Pipette and Biofunctional Elastomeric Microparticle System for Rapid Picomolar-level Biomolecule Detection in Whole Blood

New Device Could Deliver Bedside Blood Test Results in an Hour

Handheld Diagnostic Performs 1-hour Blood Tests from a Finger Prick

New Handheld Device Could Deliver Bedside Blood Test Results in Under an Hour

University of Michigan National Study Finds Nearly Half of Seniors Surveyed Purchased At-Home Medical Tests and Most Plan to Buy More

Clinical laboratory executives and pathology leaders may want to develop strategies for supporting the growing numbers of at-home screening and diagnostic test users

Findings of a national poll conducted by the University of Michigan (U-M) exploring consumers’ purchases suggests seniors are becoming more comfortable with ordering and using at-home medical testing. Their choice of tests and opinions may be of interest to clinical laboratory executives, pathologists, and primary care physicians considering programs to support self-test purchasers.

Conducted through U-M’s Institute for Healthcare Policy and Innovation, the National Poll on Healthy Aging study involved 2,163 adults over age 50, who responded to questions online or by phone in January 2022.

The researchers found that 48% of adults, ages 50 to 80, purchased at least one at-home medical test, and that 91% of the buyers indicated intentions to purchase another test in the future, according to a U-M news release.

The researchers published their study, “Use of At-Home Medical Tests among Older US Adults: A Nationally Representative Survey,” in The Journal of Health Care.

In their paper, they note that “validity, reliability, and utility of at-home tests is often uncertain.” Further, understanding and responding to test results—especially since caregivers may not have ordered them—could lead to “a range of unintended consequences,” they wrote.

“As a primary care doctor, I would want to know why my patient chose to take an at-home test that I didn’t order for them. We also need to understand in greater detail why folks use at-home tests instead of traditional means, beyond convenience,” said the U-M study’s lead author Joshua Rager, MD, a research scientist at William M. Tierney Center for Health Services Research at Regenstrief Institute, who is now an assistant professor of medicine, Indiana University, in a news release. The findings of the U-M study will be of interest to clinical laboratory executives and pathology leaders. (Photo copyright: Regenstrief Institute.)

Free COVID-19 Tests Ignite At-Home Testing

In their Journal of Health Care paper, the U-M researchers speculate that curiosity in at-home testing may have been propelled by the offer of free COVID-19 tests by the US government starting in 2021 during the pandemic.

They also noted the different ways at-home test kits are performed by healthcare consumers. Some, such as COVID-19 rapid antigen tests, return results to users in a few moments similar to pregnancy tests. Others involve self-collecting specimens, such as a stool sample, then sending the specimen to a clinical laboratory for analysis and results reporting to physicians.

Abbott’s BinaxNOW COVID-19 Ag Card (SARS-CoV-2 test) and Exact Sciences’ Cologuard (colorectal cancer screening test) are examples of two different styles of testing.

Of those older adults who participated in U-M’s National Poll on Healthy Aging study, the following bought at-home medical tests online or from pharmacies and supermarkets, according to U-M’s paper:

Opinions, Sharing of At-Home Test Results Vary

As to perceptions of at-home medical testing by users, when polled on their test experience, the surveyed seniors reported the following:

  • 75.1% perceived at-home medical tests to be more convenient than conventional medical tests.
  • 59.9% believe the tests “can be trusted to give reliable results.”
  • 54.8% believe the tests “are regulated by government.”
  • 66% called them a “good value.”
  • 93.6% indicated results “should be discussed with my doctor.”

Inconsistency in how people shared test results with their healthcare providers was a concern voiced by the researchers.

“While nearly all patients who had bought an at-home cancer screening test shared the results with their primary care provider, only about half of those who tested for an infection other than COVID-19 had. This could have important clinical implications,” the researchers wrote in their paper.

Confusion over Government Regulation

The U-M study also revealed consumer misunderstanding about government regulation of at-home clinical laboratory tests purchased over-the-counter.

The US Food and Drug Administration (FDA) cleared “some diagnostic at-home tests for over-the counter use. But many tests on the market are unregulated or under-regulated,” the authors wrote, adding, “Our results suggest, however, that patients generally believe at-home tests are regulated by government, but a substantial minority did not, which may reflect public confusion in how at-home testing is regulated.”

Women, College-Educated Buy More At-Home Tests

Purchase of at-home tests varies among groups, as follows, the news release noted:

  • 56% and 61% of older adults with a college degree or household income above $100,000, respectively, were “much more likely” to buy at-home tests than people in other income and education brackets.
  • 87% of women would buy at-home tests again compared with 76% of men.
  • 89% of college-educated people would purchase the tests again, compared with 78% of people with high school educations or less.

Future U-M research may explore consumers’ awareness/understanding concerning federal regulations of at-home testing, Rager noted.

“At-home tests could be used to address disparities in access to care. We hope these findings will inform regulators and policymakers and spark future research on this topic,” he said in the news release.

The U-M Institute for Healthcare Policy and Innovation survey results confirm that the country’s senior generations are becoming comfortable with at-home and self-testing options. As Dark Daily has previously suggested, clinical laboratories may want to develop service offerings and a strategy for supporting patients who want to perform their own lab tests at home.

—Donna Marie Pocius

Related Information:

Big Gaps Seen in Home Medical Test Use by Older Adults

Use of At-Home Medical Tests among Older US Adults: A Nationally Representative Survey

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