After three years of research and development, an AdventHealth physician and clinical team created a new test to diagnose a brain-eating amoeba within three hours.
Identifying and treating this condition is extremely time-sensitive and difficult, as the amoeba kills its host in only 3-7 days and previous testing routinely took up to six days. This means patients often died before tests could confirm the presence of an amoeba or treatment could begin.
Now, physicians at the AdventHealth Central Florida Division can receive results in a few hours, allowing the clinical team to begin treatment more quickly. In addition, AdventHealth physicians in other southern states can get results in roughly 24 hours from specimen receipt at the Orlando campus.
BRAIN-EATING AMOEBA FACTS:
· The brain-eating amoeba, also known as Naegleria fowleri, is one of several growing health concerns across the U.S. It kills more than 97% of people infected due to delays in identifying and treating the illness.
· Testing has been very imprecise, slow, cumbersome and unreliable for identifying exactly which amoeba has infected a patient (which dictates the specific treatment needed).
· Historically, testing takes 3-6 days, while the amoeba kills its host in only 3-7 days. In most cases, test results reveal the presence of this amoeba only after the patient has already died.
· There are only five known survivors of this infection in North America. One survivor, Sebastian DeLeon, was treated in 2016 at AdventHealth for Children.
· While the fatality rate is extremely high, cases do not occur in quantities that are profitable for lab companies to invest in the research and development to improve testing.
Reflecting on the impact of this groundbreaking new test developed at AdventHealth, Jose Alexander, M.D., clinical microbiologist and director of microbiology, virology and immunology for AdventHealth Orlando, answered several questions about the severity of brain-eating amoebas, what makes this new test different and what led him on this journey of innovation.
Q: What should physicians know about potential Naegleria fowleri infections?
A: Primary Amebic Meningoencephalitis (PAM), which is a disease caused by an infection with Naegleria fowleri, typically increases its prevalence during summer, but changing epidemiological and geographic conditions mean this is not always the case.
Due to the increasing duration of high temperatures across the country – a result of climate change – the presence of this heat-loving, brain-eating amoeba is spreading across more states each year. Historically, most cases occur in Florida and Texas, along with other southern states, though cases are beginning to creep northward.
Clinical awareness of these conditions is critical for a rapid suspected diagnosis and confirmatory testing, which can then prompt the initiation of appropriate treatment. It is important that PAM is considered among the earlier differential diagnosis.
Q: Can this new test identify other amoebas?
A: Yes. We developed this new rapid polymerase chain reaction (PCR) test in the AdventHealth Microbiology Lab to screen for the three most common free-living amoebas at once. Along with Naegleria fowleri, it also detects:
Balamuthia mandrilaris – Found in soil and very deadly. This amoeba is responsible for a rare and serious infection of the brain called granulomatous amebic encephalitis (GAE).
Acanthamoeba spp. – Also found in soil, bodies of water, food, surfaces, air conditioning and heating systems and animal tissue. This amoeba causes eye infections and is commonly found infecting contact lenses.
With a short turnaround time from specimen receipt, our test is offered 24/7 and is designed to be highly sensitive and identify low levels of amoebas in spinal fluid.
Q: What makes this test different from other national testing options for amoebas?
A: There are two or three other molecular-based methods across the nation, each using a different molecular approach. The Centers for Disease Control and Prevention (CDC) is the main reference center and can identify Naegleria fowleri on spinal fluid by a PCR test and this test has its own technical specifications.
Our test can screen and identify the three more clinically significant free-living amoebas during the same run, where the CDC assays are individually focused. Also, our test can be performed in samples held and transported at room temperature, facilitating the logistics and expediting the transportation of the specimen.
Q: What led you and your team to invest in developing this testing?
A: AdventHealth had two significant cases in recent years, so our team clearly understood the critical importance of a rapid and reliable diagnostic tool, but unfortunately, there is not a commercially available molecular test for detecting free-living amoebas in cerebrospinal fluid (CSF). This led us to start this journey to innovate and improve the outcomes for future patients with suspected PAM, using our expertise and internal resources.
Initially, we developed a microscope-based method, but it was time consuming and lacked the sensitivity needed to identify low levels of amoebas in spinal fluid. We took it to the next level by developing this molecular-based method to obtain the quality result we were hoping for.
Q: Tell us a little more about the research that went into developing this test?
A: Pre-pandemic, we researched and read about various molecular approaches, and a rapid PCR-based assay seemed to be the most practical, quick and sensitive method.
We used the Aries multiplex PCR open platform intended for Laboratory Developed Test (LDT) for this assay and began the initial testing and fine-tuning process.
During the pandemic, this project was placed on hold because AdventHealth was one of the first health systems to perform in-house COVID-19 testing and the Aries platform was rapidly converted to perform COVID-19 testing. However, our team’s learnings from early COVID PCR testing gave us valuable insights that helped us further develop this amoeba PCR test.
As COVID-19 cases decreased in January 2022, we resumed this project and were able to fully launch this test for patient use on July 24.
Q: What learnings can you share with other physicians from this experience?
A: PAM is one of many infectious syndromes where there is a gap in diagnostic methods or understanding the clinical need for an appropriate treatment.
Although my team is not in a research department and we do not a have dedicated research budget, we always focus on translational research and look for opportunities to improve or design a diagnostic method, protocol or algorithm with a positive patient impact.
My advice to fellow physicians is to have a broad, comprehensive understanding of the problem, research the current methods or guidelines available and then challenge ourselves and ask the question, “how do we make it better?”
For physicians with medical staff privileges at AdventHealth, this new test is currently available in Epic as “Amoeba Screen, CSF.” For physicians at AdventHealth locations not yet on Epic, the test is available as a send out to AdventHealth Orlando as a reference laboratory. All other physicians can contact Jose Alexander, M.D. at firstname.lastname@example.org for more information or for potential cases.