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Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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COLA Clinical Laboratory Workforce Summit in Fort Worth, Texas, Engages Stakeholders in Effort to Train More Medical Laboratory Scientists

Representatives from almost 50 different clinical laboratories, professional associations, and societies came together this week to align efforts to expand the supply and retention of qualified laboratory scientists

FORT WORTH, TEXAS—Last week, representatives from a broad cross section of clinical laboratories, lab and pathology associations, public health laboratories, and lab regulatory bodies gathered specifically to identify ways to expand the number of skilled lab professionals.

COLA organized the “Workforce Action Alliance Summit,” a one-day gathering of key clinical laboratory stakeholders who share a common interest in developing initiatives that would directly increase the number of individuals choosing to pursue a career in laboratory medicine.

This is not a new problem, as the lack of trained laboratory scientists across all scientific disciplines has been acute for many years.

COLA Graphic
The logo above was developed by COLA to support the Workforce Action Alliance Summit. This year’s first work session took place last week in Fort Worth, Texas. Participants came from such organizations as the CDC Division of Laboratory Systems (DLS), American Society for Clinical Laboratory Science (ASCLS), American Society for Clinical Pathology (ASCP), Association of Public Health Laboratories (APHL), and American Association for Clinical Chemistry (AACC), along with a number of clinical laboratories. The goal of this initiative is to pull together wide-ranging interests within the profession of laboratory medicine and align specific efforts with projects that directly increase the recruitment, training, and retention of skilled laboratory scientists. (Graphic copyright: COLA.)

Call to Action

In a communication sent to invited participants, COLA’s CEO, Nancy Stratton, and COO, Kathy Nucifora, described the objective of the summit, writing:

“Clearly a call to collective action is required if we are to address the impending clinical laboratory workforce shortage. The past three years have demonstrated the significance of a resilient laboratory infrastructure, not only for the daily care of millions of Americans, but also during the global pandemic. The numerous efforts currently underway to resolve the shortage are unquestionably a component of the solution. Many, however, believe that these efforts are insufficient to close the gap between the projected number of new entrants into the profession, the rate at which those currently in the profession are departing, and the future demand for laboratory testing.”

Robert L. Michel, Editor-in-Chief of Dark Daily’s sister publication The Dark Report was a participant at COLA’S workforce summit. The Dark Report regularly profiles clinical laboratory organizations that have developed innovative and productive initiatives designed to increase the number of students choosing to train as medical technologists (MTs), clinical laboratory scientists (CLSs), medical laboratory technologists (MLTs) and other skilled lab positions.

In materials distributed at the summit, the ongoing gap between demand for skilled lab professionals and the supply was illustrated thusly:

“The US Department of Labor estimates 320,000 bachelors and associates degreed laboratory professionals are working in the United States. If each of those professionals worked a standard 40-year career, the natural annual attrition of 2.5% would require 8,000 new professionals to maintain their current numbers. This exceeds the current output of accredited educational programs by more than 1,000 annually.” 

Case Studies of Success

Over the course of the day, participants at the summit heard about the successes of certain laboratory organizations designed to get more students into training programs, supported by the educational courses required for them to become certified in their chosen area of laboratory medicine. These case studies centered around several themes:

  • Obtaining funding specifically to establish an MT/CLS training program to increase the number of candidates in a region. One example involved ARUP Laboratories and its success at working with a local Congressional representative to get a $3 million federal grant funded as part of a larger legislative package.
  • The medical laboratory scientist (MLS) program at Saint Louis University (SLU) worked with Quest Diagnostics to launch an accelerated bachelor’s degree program. The 16-month program combines online academic courses with intensive hands-on learning and clinical experiences in Quest’s Lenexa, Kansas, laboratory. The first students in this accelerated degree program began their studies in the spring semester of 2023.
  • By rethinking the structure of its existing didactic and experiential learning structure, NorthShore University HealthSystem’s MLS program, located at Evanston Hospital north of Chicago, doubled its enrollment capacity.

During the afternoon, working groups addressed ways that lab organizations can collaborate to increase recruitment and retention of laboratory scientists across all disciplines of lab medicine. This input was synthesized into action planning for the three priorities that can lead to expanding the lab workforce.

By day’s end, several working groups were organized with specific next steps. COLA is taking the lead in managing this initiative and giving it momentum. All clinical laboratory professionals and pathologists are welcome to participate in the Workforce Action Alliance (WAA). Anyone wishing to learn more can contact COLA by clicking here, calling 800-981-9883, or by visiting https://education.cola.org/contact-us-page.

Robert L. Michel

Related Information:

COLA Workforce Action Alliance Summit

Building the Capacity and Resiliency of the Laboratory Workforce

Industry Execs Will Convene to Address the Lab Workforce Shortage

Executives Convene to Address the Laboratory Workforce Shortage

High School Students in Upstate New York Learn 60 Critical Medical Laboratory Skills

Program launched by a Rochester-area technical center is intended to provide early study for students interested in a career in clinical laboratory medicine

Acute shortages of clinical laboratory staff across all types of skills is one of the big stories of this new year. It is also triggering unconventional approaches to reach students in high school and interest them in careers as medical technologists (MTs). One such example is a high school in New York that now offers a top-level medical laboratory program designed to create interest—then train—high school students for a career in laboratory medicine.

A recent CLP podcast, titled, “Has a High School Found the Solution to the Laboratorian Shortage?” outlined the Medical Laboratory Assisting and Phlebotomy program that is offered to students at Western Monroe and Orleans Counties (WEMOCO) Career and Technical Center in Spencerport, New York, a suburb of Rochester.

“With the acute shortage of medical technologists, this effort by one high school to reach students early and encourage them to pursue a career in clinical laboratory medicine should be of interest to all laboratory professionals,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report.

Jim Payne

“Our juniors and seniors in high school will learn about 60 employable laboratory skills,” said Jim Payne (above), a Medical Laboratory Assisting and Phlebotomy program instructor at WEMOCO. “They learn not only medical laboratory skills, but [the skills] are transferable to biotechnology, to chemical labs, food labs, environmental labs, research, forensics, and so on. The goal is each individual student comes out skilled in all 60 skills.” Clinical laboratories may want to explore creating similar programs with high schools in their own areas. (Photo copyright: Twitter.)

Dynamic Curriculum of Clinical Laboratory Skills

During the first year of the WEMOCO program, students learn skills that Jim Payne, a Medical Laboratory Assisting and Phlebotomy program instructor at WEMOCO, stated he learned in college. These include:

The students also learn the theories and techniques behind phlebotomy and how to perform blood draws (venipuncture).

Students spend 40 hours drawing blood samples from real patients in local medical laboratories and can earn a certification as a Phlebotomy Technician after completing the necessary coursework.

During the second year of the program, students learn college-level:

They also receive their certifications in American Red Cross CPR/AED and First Aid and spend 80 hours actually working in local clinical laboratories. Upon completion of the second year of coursework, students can earn a certification as a Certified Medical Laboratory Assistant.

“In both cases, they can get jobs straight out of the program,” said Payne in the CLP podcast. “But a lot of our grads go on to college for medical laboratory careers.”

Overcoming Vocational School Stigma

Recruiting students into the program was initially challenging as some of the negative stigma surrounding non-traditional coursework had to be overcome. Vocational education is now referred to as career and technical education and the WEMOCO program is more academically focused than previous vocational studies. Students can obtain some college credits when completing the two-year program.

“With my students, when we are teaching them how to do the math around making laboratory solutions, for example, that requires algebra,” Payne explained. “And they have to actually make something with the algebra and suddenly it starts to make a lot more sense than the way that they were taught in a traditional high school.”

In addition, some students interested in the program struggled in a typical high school environment due to lack of direction, according to Payne. However, when those same students found their focus, discovered a passion, and were motivated and challenged, they flourished. 

Originally, Payne gave a talk to potential enrollees. But he found there was more interest if students were given a hands-on experience at their first exposure to the program. He also lets current students interact with interested students and allows them to answer any questions in a student-friendly manner. 

“Students who are interested in the program come in, they get lab coats on, they get gloves on, and they are then told a story about a case and have to perform a few experiments to try to determine what is wrong with a patient. They actually do things,” Payne explained.

Multiple Career Paths in Clinical Laboratories upon Graduation

One advantage to completing the two-year WEMOCO program is that students can explore all the different careers in clinical laboratory medicine and are offered opportunities to work in medical laboratory situations. Phlebotomy students perform 40 hours of work in a blood lab with a goal of performing 50 successful sticks, although many students perform more than that.

“I have students who are under the age of 18 drawing blood on real patients with real samples with these companies’ trainers. It’s like they have been hired,” Payne said. The medical laboratory assistant work is broken up into increments of two hours a day over the course of several months.

Another benefit to the WEMOCO program is that students are prepared for a job right out of high school, which pleases both the students and the parents. Many graduates of the program go on to college to study different fields within the clinical laboratory profession.

Attracting Young Students to the Clinical Laboratory Profession

Payne believes it is important to get young kids interested in the medical laboratory profession in the lower grade levels. His suggestions for stoking that level of interest include:

  • Developing programs that are age-appropriate but contain medical laboratory concepts.
  • Outreach programs where clinicians talk to students in the lower grades to spark interest.
  • Outreach programs where kids can perform simple experiments like staining onions and seeing results.
  • Telling stories and explaining the roles labs play in helping patients.
  • Holding field trips where students visit local clinical laboratories and observe medical laboratory professionals.
  • Opportunities for students to shadow medical laboratory technicians so the kids can imagine themselves in the profession.
  • Participating in local activity day/career day events.

He also believes that clinical laboratory professionals should promote their field at every opportunity.

“The biggest thing is actively advocating for the profession. Any chance I get, I’m going out and trying to talk to anyone about the clinical laboratory. Try to have some statistics in your back pocket or other things that can be a good talking point and make a powerful statement to people,” Payne suggested.

Determining unique ways to garner interest in the medical laboratory profession is a crucial step in mitigating staffing shortages. Clinical laboratory leaders may want to participate in community outreach programs and serve as advocates for their profession.

JP Schlingman

Related Information:

Has a High School Found the Solution to the Laboratorian Shortage?

Medical Laboratory Assisting and Phlebotomy

Forbes Senior Contributor Covers Reasons for Growing Staff Shortages at Medical Laboratories and Possible Solutions

Critical Shortages of Supplies and Qualified Personnel During the COVID-19 Pandemic is Taking a Toll on the Nation’s Clinical Laboratories says CAP

During Pandemic, Clinical Laboratories Should Be Alert for Drug Resistant Infections That Pose High Risk to COVID-19 Patients

On top of everything else during this pandemic, drug-resistant infections are threatening the most vulnerable patients in COVID-19 ICUs

New study by researchers at the University of Minnesota highlights the continuing need for microbiologists and clinical laboratories to stay alert for COVID-19 patients with drug-resistant infections. In their study, researchers highlighted CDC statistics about the number of Candida auris (C. auris) infections reported in the United States during 2020, for example.

In a paper, titled, “Three Cases of Worrisome Pan-Resistant C Auris Found in New York,” the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota reported that “As of Dec 11, the CDC said 941 confirmed and probable C. auris cases have been reported in 13 states, and an additional 1,830 patients have been found to be colonized with the multidrug-resistant fungus. Most of the cases have been detected in the New York City area, New Jersey, and the Chicago area.”

Candida auris is a particularly nasty fungus. It spreads easily, is difficult to remove from surfaces, and can kill. Worst of all, modern drugs designed to combat this potentially deadly fungus are becoming less effective at eradicating it, and COVID-19 ICU patients appear especially vulnerable to C. auris infections.

In “Potentially Fatal Fungus Invades Hospitals and Public Is Not Informed,” Dark Daily reported how Candida auris’ ability to elude detection makes decontamination of hospital rooms far more complicated. And in “CDC Ranks Two More Drug-Resistant Microbes as ‘Urgent Threat’ to Americans; Clinical Laboratories Are Advised to Increase Awareness of Antimicrobial Resistance,” we covered how the federal Centers for Disease Control and Prevention (CDC) added C. auris to its “Biggest Threats and Data: Antibiotic Resistance Threats in the United States” report for 2019.

COVID-19 and C. auris a Potentially Devastating Combination

Hospitals in many areas are at a critical capacity. Thus, hospital-acquired infections such as sepsis can be particularly dangerous for COVID-19 patients. Adding to the problem, C. auris requires special equipment to identify, and standard medical laboratory methods are not always enough. Misidentification is possible, even probable.

A paper in the Journal of Global Antimicrobial Resistance (JGAR), titled, “The Lurking Scourge of Multidrug Resistant Candida Auris in Times of COVID-19 Pandemic,” notes that “A particularly disturbing feature of COVID-19 patients is their tendency to develop acute respiratory distress syndrome that requires ICU admission, mechanical ventilation, and/or extracorporeal membrane oxygenation. … This haunting facet of COVID-19 pandemic has severely challenged even the most advanced hospital settings. Yet one potential confounder, not in the immediate attention of most healthcare professionals, is the secondary transmission of multidrug resistant organisms like the fungus Candida auris in COVID-19 ICUs. … C. auris outbreaks occur in critically ill hospitalized patients and can result in mortalities rates ranging from 30% to 72%. … Both C. auris and SARS-CoV-2 have been found on hospital surfaces including on bedrails, IV poles, beds, air conditioner ducts, windows and hospital floors. Therefore, the standard COVID-19 critical care of mechanical ventilation and protracted ventilator-assisted management makes these patients potentially susceptible to colonization and infections by C. auris.”

One study mentioned in the JGAR paper conducted in New Delhi, India, looked at 596 cases where patients were admitted to the ICU with COVID-19. Fifteen of them had infections caused by C. auris. Eight of those patients died. “Of note, four patients who died experienced persistent fungemia and despite five days of micafungin therapy, C. auris again grew in blood culture,” according to reporting on the study in Infection Control Today (ICT).

Some C. auris mortality rates are as high as 72%. And patients with weakened immune systems are at particular risk, “making it an even more serious concern when 8% to 9% of roughly 530,000 ICU patients in the United States have COVID-19,” ICT reported.

Apparently, the COVID-19 pandemic has created circumstances that are particularly suited for C. auris to spread. “Given the nosocomial transmission of SARS-CoV-2 by those infected, many hospital environments may serve as venues for C. auris transmission as it is a known environmental colonizer of ICUs,” wrote the JGAR paper authors.

CDC Reports and Recommendations

Along with being especially dangerous for people with weakened immune systems, C. auris infections also produce symptoms similar to those of COVID-19, “including fever, cough, and shortness of breath,” according to the CDC’s website. People admitted to ICUs with COVID-19 are especially vulnerable to bacterial and fungal co-infections. “These fungal co-infections are reported with increasing frequency and can be associated with severe illness and death,” says the CDC.

C. auris outbreaks in the United States have mostly been in long-term care facilities, but the pandemic seems to be changing that and more outbreaks have been detected in acute care facilities, the CDC reported. The lack of appropriate personal protective equipment (PPE), changes in infection control routines, and other factors could be to blame for the increase.

Just as community spread is an issue with COVID-19 variants, so too is it a concern with C. auris infections. “New C. auris cases without links to known cases or healthcare abroad have been identified recently in multiple states, suggesting an increase in undetected transmission,” the CDC noted.

As of January 19, 2021, according to the CDC the case count of C. auris infections in the US was 1,625, with California, Florida, Illinois, New Jersey, and New York having more than 100 cases each.

According to a CDC report, “Candida auris (C. auris) is an emerging multidrug-resistant yeast (a type of fungus). It can cause severe infections and spreads easily between hospitalized patients and nursing home residents.” The graphic above, taken from the report, illustrates how “C. auris began spreading in the United States in 2015. Reported cases increased 318% in 2018 when compared to the average number of cases reported in 2015 to 2017.” (Graphic copyright: Centers for Disease Control and Prevention.)

Using Clinical Laboratory Tests to Identify C. Auris

One of the big concerns about C. auris is that it is so difficult to detect, and that medical laboratories in some countries simply do not have the technology and resources to identify and tackle the infection.

“As C. auris diagnostics in resource-limited countries is yet another challenge, we feel that alerting the global medical community about the potential of C. auris as a confounding factor in COVID-19 is a necessity,” wrote the authors of the paper published in the Journal of Global Antimicrobial Resistance.

As if the COVID-19 pandemic has not been enough, drug resistant bacteria, viruses, and deadly fungi are threatening to wreak havoc among SARS-CoV-2 infected patients. Microbiologists and medical laboratory scientists know that testing for all types of infections is vitally important, but especially when it comes to infections caused by antibiotic-resistant bacteria (ARB) and other dangerous organisms that demonstrate antimicrobial resistance (AMR).

Microbiologists and clinical laboratory professionals will want to stay informed about the number of C. auris cases identified in the US and the locations and settings where the fungus was detected. They will want to be on the alert within their hospitals and health networks, as well as with the doctor’s offices served by their labs.

—Dava Stewart

Related Information:

Potentially Fatal Fungus Invades Hospitals and Public Is Not Informed

CDC Ranks Two More Drug-Resistant Microbes as ‘Urgent Threat to Americans; Clinical Laboratories Are Advised to Increase Awareness of Antimicrobial Resistance:

Biggest Threats and Data: Antibiotic Resistance Threats in the United States report for 2019

Three Cases of Worrisome Pan-Resistant C auris Found in New York

COVID Unleashes the ‘Lurking Scourge’ Candida Auris

The Lurking Scourge of Multidrug Resistant Candida auris in Times of COVID-19 Pandemic

CDC: Fungal Diseases and COVID-19

CDC: Candida auris

Consumer Trend to Use Walk-In and Urgent Care Clinics Instead of Traditional Primary Care Offices Could Impact Clinical Laboratory Test Ordering/Revenue

Primary care is shifting from traditional office visits to urgent care and walk-in clinics even as large hospital groups continue to buy up independent physician practices, altering where and from whom clinical laboratories receive referrals and test orders

Medical test ordering and referrals from office-based physicians are the financial foundation of the clinical laboratory industry. Thus, recent trends reshaping how and where physicians practice medicine, and the ownership of their medical groups, could have both beneficial and adverse implications for medical laboratories and anatomic pathology groups.

Primary care doctors who own their own medical practices are disappearing from the healthcare landscape at an impressive rate, as large hospital groups expand their share of the primary care market. According to the New York Times (NYT), in 2010, large hospital groups employed 23% of the nation’s primary care physicians. By 2016, that number had increased to 43%.

However, office visits to primary care physicians fell by 18% between 2012 and 2016, according to a report by Health Care Cost Institute (HCCI). During the same period, visits to specialists rose 31%.

Walk-In and Urgent Care Clinics Replacing Traditional Office Visits

An increasing number of patients are selecting different types of providers when seeking medical care. Convenience, low cost, and shorter wait times have many patients choosing urgent care and retail or walk-in clinics instead of traditional office visits. Dark Daily reported on this growing trend last fall in “Five Reasons Why Retail Clinics Are a ‘Game-Changing’ Threat to Traditional Healthcare Providers That Could Strain Clinical Laboratories and Pathologists.”

The number of retail or walk-in clinics in the United States has increased by 14 times over the past decade, according to Statista, a provider of market and consumer data. In 2008, there were only 200 retail clinics in the country. Current projections indicate there will be 2,800 walk-in clinics located throughout the country by the end of this year.

In 2010, retail clinic sales totaled $518 million. By the end of 2016, retail clinic sales were more than $1.4 billion representing an increase of 20.3% per year during that time period, according to the Kalorama report, “Retail Clinics 2017: The Game-Changer in Healthcare.”

Jeffrey D. Le Benger, MD, FACS

“There is huge consolidation in the market right now,” Jeffrey D. Le Benger, MD, FACS (above), Chief Executive Officer of Summit Medical Group in New Jersey, told the NYT. “Everyone is fighting for the primary care patient.” (Photo copyright: Gannett.)

Retail or walk-in health clinics were originally intended for uninsured and underinsured individuals who sought an affordable option for medical services. These clinics are designed to treat non-emergency situations, such as burns, sprains, and minor infections or illnesses. Services at these clinics are usually administered by a nurse practitioner.

Retail walk-in clinics often are located inside larger, popular stores. Examples include:

Providing 24/7 Healthcare Services at Lower Costs

In contrast, urgent care clinics are equipped to handle more serious, non-emergency injuries and conditions and are generally staffed by physicians. The Urgent Care Association of America states that there are more than 7,500 urgent care centers in the US with an annual revenue of $18 billion. This industry is expected to grow by 5.8% in 2018. The largest urgent care group in the country—MedExpress Urgent Care in Morgantown, W.Va.—has 252 locations in 22 states.

Another growing urgent care center—ZoomCare of Portland, Ore.—has 36 locations in Oregon and Washington State. Services offered include: urgent care, primary care, pediatrics, gynecology, orthopedics, dermatology, dental care, ear nose and throat, chiropractic, podiatry, physical therapy, mental health, immunity, imaging, internal medicine, clinical laboratory, and prescriptions. They offer convenient, extended hours and some locations are open seven days a week.

“Our customers are looking for world-class conveniences,” Albert DiPiero, MD, co-founder and Chief Medical Officer at ZoomCare, told Portland Monthly.

ZoomCare lists its menu of services/cost for both insured and self-pay patients on its website. Basic medical laboratory tests include:

  • Strep-$50;
  • Urine-$20;
  • Mononucleosis test-$20;
  • Pregnancy-$20; and,
  • Influenza A/B-$40.

The website states that half of ZoomCare’s medications cost less than $10, and five out of six of the medicines are less than $20.

With such low costs and easy accessibility, it’s understandable why the number of patients seeking care in non-traditional office settings is growing. Clinical laboratories must accept and support these new sites of healthcare delivery to ensure continued procurement of lab test referrals. Staying on top of these trends and adjusting to consumer demand will help labs thrive and survive in healthcare’s ever-changing landscape.

—JP Schlingman

Related Information:

How ZoomCare is Shaking up the Checkup

The Disappearing Doctor: How Mega-Mergers Are Changing the Business of Medical Care

Healthcare Mega Mergers Push Primary Care Clinics Closer to Extinction: Five Takeaways

AETNA and ZoomCare Announce New Accountable Care Collaboration in Oregon

Number of Retail Clinics in the United States from 2008 to 2018

Retail Clinics 2017: The Game-Changer in Healthcare

Urgent Care Industry Hits $18 Billion as Big Players Drive Growth

Five Reasons Why Retail Clinics Are a “Game-Changing” Threat to Traditional Healthcare Providers That Could Strain Clinical Laboratories and Pathologists

Children’s Study Determines MicroRNA in Saliva Can Accurately Diagnose Acute and Prolonged Concussion Symptoms; Could Lead to New Medical Laboratory Tests and Point-of-Care Diagnostics

Research published in JAMA Pediatrics reports that non-invasive salivary microRNA testing identifies prolonged concussion symptoms with 85% accuracy

Sports-related concussions are always tragic, but doubly so when they involve child athletes. Quick diagnoses and treatments are critical to prevent permanent brain injury. But doctors are often hampered by the pace at which traditional medical imaging modalities and clinical laboratory diagnostic technologies provide crucial feedback.

Now, researchers at Penn State Health Children’s Hospital have determined that microRNA in saliva could be used as biomarkers in point-of-care concussion testing during sports events, according to a Penn State Health news release. Such sideline saliva analyses could provide quick feedback to field doctors on whether a head injury is serious enough to put injured athletes out of play, and how long the effects of such injuries might last. But is it accurate?

Jeremiah J. Johnson, MA, BS, Department of Pediatrics, at Penn State College of Medicine in Hershey, Pa., et al, recently published a study in the Journal of the American Medical Association (JAMA) Pediatrics that evaluated the ability of salivary microRNA to identify concussion in children. The salivary test of microRNA levels, Johnson and colleagues argued, does accurately identify the “duration and character of concussion symptoms.” According to the researchers, the test demonstrated high prognostic potential as a “toolset for facilitating concussion management” and may provide an additional biomarker source for use in clinical laboratory testing.

MicroRNA Offers New Biomarkers for Concussion Diagnosis

The study tested the saliva of 52 adolescents with a clinical diagnosis of mild traumatic brain injury in the form of concussion for specific microRNA expressions. Researchers identified five microRNA molecules which “accurately identify” patients with concussion symptoms. Three of those molecules served to diagnose specific symptoms of headache, fatigue, and memory difficulties up to one month after injury with low false detection rates. Because these microRNA molecules are not specific to children, could the test maintain diagnostic accuracy for patients of all ages?

William P. Meehan III, MD, with the Micheli Center for Sports Injury Prevention at Boston General Hospital, and Rebekah Mannix, MD, MPH, with the Brain Injury Center at Boston Children’s Hospital wrote an editorial responding to the original research article stating that “the use of salivary microRNA in this study is both novel and clinically relevant.” Adding that “using this salivary microRNA panel to diagnose and manage concussions could be a major advancement to the field.”

Meehan and Mannix also remarked on the speed and relative ease of obtaining saliva samples, stating that “salivary microRNAs could also offer insights into the underlying biological mechanisms of injuries, potentially identifying specific targets to modify disease.”

More Accurate than Current Concussion Diagnosis Tools

There has been a marked interest in microRNA analysis and testing in recent years. MicroRNA analysis and testing has found use in cancer prognosis and personalized medicine that help predict responses to specific treatments for individual patients with a variety of chronic diseases. The news that microRNA can be used to predict concussion and duration of symptoms further solidifies the role microRNA may play in medical laboratory testing in the near future.

In an interview with CNN, Steve Hicks, MD, PhD, senior author of the JAMA Pediatrics research article and Assistant Professor of Pediatrics at Penn State College of Medicine, reported that the salivary microRNA test predicted concussion with 85% accuracy in comparison to current clinical survey measures, which are “approximately 65% accurate.” Hicks added that “the technology required to measure saliva RNA is already employed in medicine” as a common means of testing for upper respiratory viruses and that “modifying this approach for patients with concussions could potentially provide a rapid, objective tool for managing brain injury.”

Currently the Standard Concussion Assessment Tool, Third Edition (SCAT 3), which includes a series of cognitive and physical tests, is used on sports sidelines to detect concussion symptoms. Hicks notes that one problem with SCAT 3 is that “an athlete may have a concussion even if [his or her] score is ‘normal.’” Therefore, the microRNA saliva test could provide objective evidence of concussion in patients SCAT 3 fails to accurately diagnose.

Steve-Hicks-MD

Steven D. Hicks, MD, PhD (above), led the research team that studied the use of microRNA in saliva, rather than in blood, as a biomarker to identify concussions symptoms in children, and determine how long effects of the injury might last. (Photo copyright: Penn State Health.)

Too Early to Know How Helpful the Test May Be?   

In the same CNN interview, Neurologist Jeffery Kutcher, MD, head of the Sports Neurology Clinic at The Core Institute in Brighton, Mich., stated that the Penn State study’s findings were “promising” and that “work like this is important because it does provide potential for tests that can be helpful in the clinical setting.” Kutcher cautioned however, that it was “too early to know what this type of tool can do for us.”

In an NPR article, Manish Bhomia, M.Eng., PhD, a brain injury researcher with the Uniformed Services University of the Health Sciences commented that “a saliva test could greatly improve care for young people who don’t have obvious symptoms of a concussion.” Bhomia stated that “micro-RNAs offer a promising way to assess concussions in adults as well as children,” but he is wary to laud saliva tests as the best method of measuring relevant microRNA molecules. Bhomia states that blood samples “which tend to contain greater numbers of the genetic fragments” are perhaps a better option.

Hicks disagrees. In an article from Penn State News, Hicks stated that the novel aspect of this study was that it focused on microRNA levels “in saliva rather than blood.” Thus, a test based on saliva, rather than a phlebotomy stick or more invasive blood testing, requires no need for venous blood.

“The ultimate goal is to be able to objectively identify that a concussion has happened and then predict how long the symptoms will go on for,” Hicks noted in the Penn State News article. “Then, we can use that knowledge to improve the care that we provide for children who have concussions, either by starting medicine earlier or holding them out of activities for longer.”

Quadrant Biosciences, a biotech company in Syracuse, N.Y., that helped fund the study, is hoping to “bring a saliva test for concussion to market in the next 12 to 24 months,” according to Hicks in his CNN interview. If development proceeds as planned, the saliva test could prove a “game changer” for sports medicine diagnostics and possibly open new avenues for related microRNA in clinical laboratory testing.

Amanda Warren

Related Information:

Prolonged Concussion Symptoms Identifiable by Salivary MicroRNA

Association of Salivary MicroRNA Changes with Prolonged Concussion Symptoms

Promise of Salivary MicroRNA for Assessing Concussion

Spit Test May Diagnose, Predict Duration of Concussion in Kids

Molecules in Spit May Be Able to Diagnose and Predict Length of Concussions

Spit Test May Help Reveal Concussion Severity

Meet the Clinical Pathology Laboratory on the Palm of a Hand: Japanese Researchers Announce A Point-Of-Care Testing Device That Detects MicroRNA in 20 Minutes

With Launch of RNAcentral Database, Pathologists Now Have Unprecedented Access to RNA Data

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