As a deployable medical laboratory, the 1st AML is designed to run field-based clinical laboratory diagnostics and conduct health threat assessments
Clinical laboratory professionals may be surprised to learn that the US Army has a deployable medical laboratory that is equipped to perform the same menu of basic lab tests as their labs here in the United States, but in support of army units deployed in the field. At the same time, the Army’s deployable medical lab has the added responsibility of testing for infectious diseases and chemicals/agents that could be used by terrorists or enemy forces.
“The 1st Area Medical Laboratory identifies and evaluates health hazards through unique medical laboratory analyses and rapid health hazard assessments of nuclear, biological, chemical, endemic disease, occupational, and environmental health threats,” according to an Army new release.
A recent visit by the leaders of this lab unit to meet with their counterparts in Poland highlights the important diagnostic work the military prepares for by using this one-of-a-kind clinical laboratory model.
Col. Matthew Grieser (left), Commander of the 1st Area Medical Laboratory (AML) is shown above meeting with Col. Przemysław Makowski, MD, (right), Deputy Commander of the Military Preventive Medicine Center in Wrocław, Poland. Leaders from the US Army’s 1st AML visited military and medical officials in Poland. “It was a great opportunity to meet our Polish counterparts and to learn from one another,” said Grieser in an Army news release. “We intend to continue to strengthen this relationship … Poland is a great ally, and it was an honor to visit our counterpart organizations.” (Photo copyright: US Army.)
Role and Makeup of the 1st Area Medical Laboratory
The 1st AML traces its roots back to World War II, where it was one of 19 field laboratories spun up in 1944. It was deactivated after the Vietnam War and then reactivated in 2004. It is currently the Army’s only deployable field laboratory, according to the National Library of Medicine.
This specialized unit deploys worldwide to conduct threat detection and medical surveillance, according to the Army. For example, the military can send the 1st AML to locations where samples cannot quickly be transported to a fixed facility, or where there is a need for immediate hazard identification due to chemical or biological contamination or epidemic disease.
During the Ebola outbreak in Liberia in 2014-2015, the 1st AML operated four blood-testing laboratories and helped oversee two others manned by Navy personnel. The goal was to perform quick turnaround times to identify local residents who carried the disease, all while operating with extensive safety measures. More than 4,500 samples were tested during a six-month stay, Army Times reported.
Commanders from the 1st AML recently met with medical officials and chemical, biological, radiological, and nuclear experts from the Polish Armed Forces in the Warsaw area of Poland, the Army news release noted.
“It was a great opportunity to meet our Polish counterparts and to learn from one another,” said Col. Matthew Grieser, Commander of the 1st AML.
Maj. Suzanne Mate, the Chief of chemical threat assessment for the 1st AML, said meeting with allies helps to keep NATO ready for any contingency.
“It’s better to know your partners before you have to work together in a high-consequence situation,” said Mate in the Army news release. “We learned the strengths in different mobility platforms for laboratories and the capabilities within fixed scientific institutions to maintain standards and currency in chemical, biological, and radiological [CBR] investigations.
“This knowledge is invaluable when determining how to move a sample quickly and efficiently to characterize a suspected CBR threat when airlift resources are constrained or country treaties prevent movement activities,” she added.
Observant clinical laboratory managers will note similarities between their own jobs and those of the 1st AML. The military needs lab-based capabilities to perform a menu of diagnostic tests in support of Army units in the field and traditional clinical laboratories do the same in support of the healthcare providers they service.
Understanding why some people display no symptoms during a COVID-19 infection could lead to new precision medicine genetic tests medical labs could use to identify people with the mutated gene
New research from the University of California San Francisco (UCSF) may explain why some people could get COVID-19 but never test positive on a clinical laboratory test or develop symptoms despite exposure to the SARS-CoV-2 coronavirus.
According to the UCSF study, variations in a specific gene in a system of genes responsible for regulating the human immune system appears to be the factor in why about 10% of those who become infected with the virus are asymptomatic.
These scientific insights did not receive widespread news coverage but will be of interest to clinical laboratory managers and pathologists who oversee SARS-CoV-2 testing in their labs.
“Some people just don’t have symptoms at all,” Jill Hollenbach, PhD (above), Professor of Neurology atUCSF’s Weill Institute for Neurosciences and lead researcher in the study, told NBC News. “There’s something happening at a really fundamental level in the immune response that is helping those people to just completely wipe out this infection.” Identifying a genetic reason why some people are asymptomatic could lead to new precision medicine clinical laboratory diagnostics for COVID-19. (Photo copyright: Elena Zhukova /University of California San Francisco.)
Fortunate Gene Mutation
According to the Centers for Disease Control and Prevention’s (CDC) COVID Data Tracker, as of April 5, 2023, a total of 104,242,889 COVID-19 cases have been reported in the United States. However, according to a CDC Morbidity and Mortality Weekly Report (MMWR), “Traditional methods of disease surveillance do not capture all COVID-19 cases because some are asymptomatic, not diagnosed, or not reported; therefore, [knowing the true] proportion of the population with SARS-CoV-2 antibodies (i.e., seroprevalence) can improve understanding of population-level incidence of COVID-19.”
She also participates in the COVID-19 HLA and Immunogenetics Consortium, a group of academic researchers, clinical laboratory directors, journal editors, and others who examine the role of HLA variations in determining COVID-19 risk.
Hollenbach’s research identified an HLA variant—known as HLA-B*15:01—that causes the human immune system to react quickly to SARS-CoV-2 and “basically nuke the infection before you even start to have symptoms,” she told NPR.
“It’s definitely luck,” she added. “But, you know, this [gene] mutation is quite common. We estimate that maybe one in 10 people have it. And in people who are asymptomatic, that rises to one in five.”
“HLA variants are among the strongest reported associations with viral infections,” the UCSF study notes. So, the researchers theorized that HLA variations play a role in asymptomatic SARS-CoV-2 infections as well.
To conduct their study, shortly after the SARS-CoV-2 outbreak in 2020, the researchers recruited approximately 30,000 volunteer bone marrow donors from the National Marrow Donor Program to respond to periodic questions via a smartphone app or website. Because HLA variations can determine appropriate matches between donors and recipients, the database includes information about their HLA types.
Each week, respondents were asked to report if they had been tested for SARS-CoV-2. Each day, they were asked to report whether they had symptoms associated with COVID-19. “We were pretty stringent in our definition of asymptomatic,” Hollenbach told NBC News. “[The respondents couldn’t] even have a scratchy throat.”
The researchers eventually identified a cohort of 1,428 people who had tested positive for SARS-CoV-2 between February 2020 and April 30, 2021, before vaccines were widely available. Among these individuals, 136 reported no symptoms for two weeks before or two weeks after a positive test.
“Overall, one in five individuals (20%) who remained asymptomatic after infection carried HLA-B*15:01, compared to 9% among patients reporting symptoms,” the researchers wrote in their medRxiv preprint. Study participants with two copies of the gene were more than eight times more likely to be asymptomatic.
The UCSF researchers also looked at four other HLA variants and found none to be “significantly associated” with lack of symptoms. They confirmed their findings by reproducing the HLA-B association in two additional independent cohorts, one from an earlier study in the UK and the other consisting of San Francisco-area residents.
Individuals in the latter group had either tested positive for SARS-CoV-2 or reported COVID symptoms, and their DNA was analyzed to determine their HLA types.
Pre-existing T-Cell Immunity May Reduce Severity of COVID-19 Infection
The UCSF researchers also attempted to determine how HLA-B*15:01 plays a role in knocking out SARS-CoV-2 infections. They noted previous research that indicated previous exposure to seasonal coronaviruses, such as common cold viruses, could limit the severity of COVID-19. The scientists hypothesized that pre-existing T-cell immunity in HLA-B carriers may be the key.
The COVID-19 HLA and Immunogenetics Consortium website describes how HLA and T-cells work together to ward off disease. HLA “proteins are found on the surface of all cells except red-blood cells.” They’re “like windows into the inner workings of a cell,” and T-cells use the molecules to determine the presence of foreign proteins that are likely signs of infection. “Activated T-cells can kill infected cells, or activate B-cells, which produce antibodies in response to an infection,” the website explains.
Hollenbach’s research team analyzed T-cells from pre-pandemic individuals and observed that in more than half of HLA-B carriers, the T-cells were reactive to a SARS-CoV-2 peptide. The scientists corroborated the hypothesis by examining crystal structures of the HLA-B*15:01 molecule in the presence of coronavirus spike peptides from SARS-CoV-2 and two other human coronaviruses: OC43-CoV and HKU1-CoV.
“Altogether, our results strongly support the hypothesis that HLA-B*15:01 mediates asymptomatic COVID-19 disease via pre-existing T-cell immunity due to previous exposure to HKU1-CoV and OC43-CoV,” the researchers wrote.
Can Genes Prevent COVID-19 Infections?
Meanwhile, researchers at The Rockefeller University in New York City are attempting to go further and see if there are mutations that prevent people from getting infected in the first place. NPR reported that they were seeking participants for a study seeking to identify so-called “superdodger” genes.
Study participants identified as possibly having superdodger genes receive a kit designed to collect saliva samples, after which the researchers sequence the respondents’ genomes. “We hope that in a group of 2,000 to 4,000 people, some people will have genetic mutations that tell us why they’re resistant to infection,” Casanova told NPR.
All this genetic research is in very early stages. But results are promising and may lead to new precision medicine clinical laboratory tests for identifying people who are predisposed to having an asymptomatic response to COVID-19 infection. That in turn could help scientists learn how to moderate or even eliminate symptoms in those unfortunate people who suffer the typical symptoms of the disease.
Hospital-at-home programs like that of Atrium Health are a trend that may create new opportunities for local clinical laboratories to support physicians treating patients in the comfort of their own homes
Here is a deal that shows the hospital-at-home (HaH) movement is gaining momentum, a trend that clinical laboratories need to recognize for the opportunities it represents. Best Buy Health is partnering with 40-hospital Atrium Health in an HaH program that the healthcare system plans to scale nationally.
This newly-announced collaboration means that Charlotte, North Carolina-based Atrium Health—as partner—may include the hospitals and providers that are part of the 26-hospital Advocate Aurora Health system (now known as Advocate Health), a non-profit healthcare system that Atrium merged with in December of 2022. Providers and hospitals from North/South Carolina, Georgia, Wisconsin, Illinois, Indiana, and Ohio all could be participating in the new HaH venture.
This latest partnership between a retail giant and healthcare network demonstrates how innovation is working its way into the US healthcare system via companies not traditionally involved in direct patient care. These two organizations see an opportunity to combine their strengths to “enhance the patient experience of receiving hospital-level care at home,” according to a Best Buy news release.
“This is the coming together of technology and empathy,” said Rasu Shrestha, MD (above), Executive Vice President and Chief Innovation and Commercialization Officer at Advocate Health, in a press release. “We’re able to leverage the power of social workers, paramedics, nurses and physicians, but also technology to take care of the patients in their homes. We can bring forward things like remote patient monitoring and sophisticated wearable devices that capture their vital signs and combine it with the human touch—bringing it directly into our patients’ homes.” Clinical laboratories that support providers in the states Advocate Health serves may want to contact Best Buy Health. (Photo copyright: Advocate Health.)
Dispatching Geek Squads to Support Telehealth in Patients’ Homes
Best Buy Health brings to its collaboration with Atrium Health expertise in omnichannel business strategies, supply chain, and a platform to enable telehealth connectivity between patients and providers, as well as deploying specially trained Geek Squad agents for in-home support, according to an Atrium Health press release.
“With Atrium Health, we want to help enable healthcare at home for everyone. It’s getting the devices to the home when Atrium Health and the patient needs them,” said Deborah Di Sanzo, President of Best Buy Health.
Atrium Health sees Best Buy Health as a partner that can grow its program while addressing complex in-home technology that can be “tricky” to operate, Retail Dive reported.
“This transition that happens from discharging a patient from a hospital to the void of their home is the dark side of the moon: it’s disconnected, confusing, expensive. What we’ve been doing in the past is working through our hospital-at-home program and putting together a lot of these devices,” Rasu Shrestha, MD, Executive Vice President and Chief Innovation and Commercialization Officer at Advocate Health, told Fierce Healthcare.
“By working with Best Buy Health, we’re developing the seamless connected care experience and an opportunity to truly scale this,” he added.
Supporting hospital-at-home services in collaboration with Atrium Health will be a new role for at least some members of the Geek Squad. “They won’t necessarily be the same team that’s doing your home theater. They will be Geek Squad agents specially trained in health to deliver specific services in the home,” said Deborah Di Sanzo, President of Best Buy Health. (Photo copyright: Best Buy.)
Best Buy’s Healthcare Acquisitions and Growth in Hospital-at-Home Programs
Current Health, a remote monitoring care-at-home platform, in 2021.
While Best Buy was busy acquiring healthcare companies, more HaH programs popped up across the US due in part to rising inpatient costs and providers’ need to be more efficient and resourceful.
Atrium Health started its Hospital-at-Home program in March 2020 as a way to care for COVID-19 patients. The HaH program now serves people with:
According to Healthcare Dive, Shrestha claimed Atrium’s HaH program “has served more than 6,300 patients and freed 25,000 hospital bed days since it launched in March 2020,” and produced clinical outcomes that were “the same or better” when compared to the health systems’ own hospitals, and with higher patient satisfaction scores.
“We anticipate the partnership will combine Atrium Health operational and clinical expertise with Best Buy Health’s technical and logistical expertise to allow us to scale the program to 100 patients at a time and beyond within our market,” Shrestha told Healthcare Dive. “When you put that into context, this would be the equivalent of having an additional mid-sized hospital and have a real impact on capacity in our bricks-and-mortar facilities.”
Taking Atrium’s HaH Program Nationwide
According to federal Centers for Medicare and Medicaid Services predictions, healthcare spending will reach $6.8 trillion by 2030. This might explain why Best Buy increased its investment in healthcare at the same time its sales declined 9.3% in the fourth quarter of 2022 amid softening consumer demand for electronics, Reuters reported.
And, according to Forbes, though financial terms on the Best Buy/Atrium Health partnership were not released, additional investments are planned to “scale [Atrium’s HaH program] beyond the system.”
“We combine our omnichannel, Geek Squad, caring centers, and Current Health services to enable care,” Di Sanzo told Forbes. “At scale, no other company has the holistic combination of resources that when combined, will change the lives of consumers and enable them to heal right in their own home surrounding by the people and things they love the most. Those strengths, combined with Atrium Health’s extensive clinical expertise and deep experience leading in virtual care, will help us improve and enable care in the home for everyone.”
Clinical Laboratory Testing at Home
Clearly there are opportunities for clinical laboratories to support providers who treat patients in their homes. Lab leaders may want to reach out to colleagues who are planning HaH programs in partnership with Best Buy Health, Atrium Health, or other companies around the nation launching similar hospital-at-home programs.
As medical laboratories address staffing challenges, HaH strategies for performing blood tests and other diagnostics on patients in their homes could lead to important new revenue.
New lawsuit contends that the promissory notes Holmes allegedly issued on behalf of defunct clinical laboratory company Theranos are now overdue
Just weeks before Elizabeth Holmes is scheduled to begin her prison term for conviction in the federal investor fraud case related to now-defunct clinical laboratory company Theranos, the long-running legal saga of the former company founder/CEO continues to bring new twists.
This time, news emerged via a lawsuit that Holmes allegedly owes $25 million to Theranos creditors. CNBC obtained a copy of the suit and detailed its contents in a March 17 case update.
Theranos ABC, a company set up on behalf of the creditors, alleged in the lawsuit that “Holmes has not made any payments on account of any of the promissory notes,” CNBC reported. The suit was filed in Superior Court of California Count of Santa Clara.
Elizabeth Holmes (above), founder and former CEO of clinical laboratory company Theranos with husband Billy Evans of Evans Hotels. Holmes lives with Evans and the couple’s two children in the area near San Jose, California. Holmes gave birth to her second baby in February, according to People. In January, Holmes was convicted on three counts of wire fraud and one count of conspiracy. In addition to restitution, Holmes has been ordered to spend up to 11 years and three months in prison. (Photo copyright: Axios.)
Holmes Allegedly Issued Three Promissory Notes
The complaint stated that Holmes allegedly executed the following three promissory notes while she was still CEO at Theranos:
August 2011 in the amount of $9,159,333.65.
December 2011 in the amount of $7,578,575.52.
December 2013 in the amount of $9,129,991.10.
A promissory note is a written promise to pay a party a certain sum of money with a specified due date for the repayment of principal and interest.
“Theranos ABC has demanded payment of promissory note one and promissory note two from Holmes, but Holmes has failed to pay any amounts on account of promissory note,” according to the lawsuit, CNBC reported. The first two notes are overdue, and the third note is due in December.
Elizabeth Holmes’ Prison Term Could Be Delayed
News of the lawsuit, which was filed in December 2022, came to light at a court hearing on March 17. During that hearing, Judge Edward Davila heard arguments about whether Holmes should remain free pending her appeal. She is otherwise scheduled to report to prison on April 27 to begin her sentence after being convicted in January 2022 of defrauding Theranos investors.
Davila, who oversaw Holmes’ criminal case, is expected to issue a decision about her freedom during the appeal early this month. The judge is also weighing options for Holmes to pay restitution to her victims.
Prosecutors have asked that she pay back $878 million to Theranos’ former investors and other victims, according to court records reviewed by Dark Daily. The government has argued in court papers that Holmes continues to live a wealthy lifestyle despite her claiming she has no meaningful assets since the collapse of Theranos and her trial.
“Defendant has lived on an estate for over a year where, based upon the monthly cash flow statement defendant provided to the US Probation Office, monthly expenses exceed $13,000 per month,” according to court documents filed by prosecutors ahead of the March 17 hearing. “Defendant asserted that her partner pays the monthly bills rather than her but also listed her significant other’s salary as ‘$0.’”
Holmes’ attorneys argued that the government cannot take an “all or nothing” approach to restitution, and that payments should only be made to investors who testified during the trial, the Associated Press reported.
For Victims, Full Restitution Can Be Rare
The federal Department of Justice (DOJ) acknowledges in its overview of restitution that victims often never collect what they are owed by guilty parties.
“The chance of full recovery is very low,” the DOJ notes. “Many defendants will not have sufficient assets to repay their victims. Many defendants owe very large amounts of restitution to a large number of victims. In federal cases, restitution in the hundreds of thousands or millions of dollars is not unusual. While defendants may make partial payments toward the full restitution owed, it is rare that defendants are able to fully pay the entire restitution amount owed.”
Clinical laboratory professionals will note the irony that one of the biggest convicted fraudsters in US history is now largely attempting to avoid punishments associated with her crimes. If Judge Davila agrees to let Holmes remain free pending her appeal, she could stay out of prison for years and perhaps not have to pay restitution for that length of time as well.
The coming weeks will prove to be pivotal in the final outcome of the case.
Viruses are between 27,000 to 48,500 years old and not dangerous, but researchers say thawing permafrost may one day release pathogens capable of infecting humans
Last fall, European researchers working with virologists and genetic scientists at the Aix-Marseille University in France reported having revived and characterized 13 previously unknown “zombie” viruses isolated from Siberian permafrost samples, including one that was almost 50,000 years old. This will be of particular interest to microbiologists and clinical laboratory managers since these organisms are new to science and may be precursors to infectious agents active in the world today.
The work of the European scientists demonstrates how advancements in genome sequencing and analysis of DNA data are becoming, faster, less expensive, and more precise. That’s good because the researchers warned that, should the permafrost continue to thaw, other previously dormant viruses could be released, posing potential risks for public health.
The pathogens isolated by the researchers are so-called “giant viruses” that infect Acanthamoeba, a commonly found genus of amoeba, and thus are not likely to pose an immediate health threat, the researchers wrote.
However, the scientists expressed concern. “We believe our results with Acanthamoeba-infecting viruses can be extrapolated to many other DNA viruses capable of infecting humans or animals. It is thus likely that ancient permafrost … will release these unknown viruses upon thawing,” they stated in their Viruses paper.
It’s unknown how long the viruses “could be infectious once exposed to outdoor conditions (UV light, oxygen, heat), and how likely they will be to encounter and infect a suitable host in the interval,” they added. However, “the risk is bound to increase in the context of global warming, in which permafrost thawing will keep accelerating, and more people will populate the Arctic in the wake of industrial ventures.”
“In nature we have a big natural freezer, which is the Siberian permafrost,” virologist Paulo Verardi, PhD (above), head of the Department of Pathobiology and Veterinary Science at the University of Connecticut, told The Washington Post. “And that can be a little bit concerning.” However, “if you do the risk assessment, this is very low. We have many more things to worry about right now.” Nevertheless, clinical laboratories may want to remain vigilant. (Photo copyright: University of Connecticut.)
Extremely Old, Very Large Viruses
The newly discovered viruses were found in seven different permafrost samples. Radiocarbon dating determined that they had been dormant for 27,000 to 48,500 years. But viruses contained in permafrost could be even older, the researchers wrote, as the time limit is “solely dictated by the validity range of radiocarbon dating.”
In their Viruses paper, the researchers noted that most of the 13 viruses are “at a preliminary stage of characterization,” and others have been isolated in the research laboratory “but not yet published, pending their complete genome assembly, annotation, or detailed analysis.”
“Every time we look, we will find a virus,” study co-author Jean-Michel Claverie, PhD, told The Washington Post. “It’s a done deal. We know that every time we’re going to look for viruses—infectious viruses in permafrost—we are going to find some.”
Claverie is a professor emeritus of genomics and bioinformatics in the School of Medicine at Aix-Marseille Université in Marseille, France. He leads a university laboratory known for its work in “paleovirology,” and in 2003, discovered the first known giant virus, dubbed Mimivirus. The research team included scientists from Germany and Russia.
According to CNN, unlike regular viruses that generally require an electron microscope to be viewed, giant viruses can be seen under a standard light (optical) microscope. Claverie’s laboratory previously isolated giant viruses from permafrost in 2014 and 2015.
Protecting Against Accidental Infection
To demonstrate the infectious potential of the viruses, the researchers inserted the microbes into cultured amoeba cells, which the researchers describes as “virus bait,” The Washington Post reported. One advantage of using Acanthamoeba cultures is to maintain “biological security,” the researchers wrote in their paper.
“We are using [the amoeba’s] billion years of evolutionary distance with human and other mammals as the best possible protection against an accidental infection of laboratory workers or the spread of a dreadful virus once infecting Pleistocene mammals to their contemporary relatives,” the paper noted. “The biohazard associated with reviving prehistorical amoeba-infecting viruses is thus totally negligible compared to the search for ‘paleoviruses’ directly from permafrost-preserved remains of mammoths, woolly rhinoceros, or prehistoric horses.”
The paper cites earlier research noting the presence of bacteria in ancient permafrost samples, “a significant proportion of which are thought to be alive.” These include relatives of contemporary pathogens such as:
“We can reasonably hope that an epidemic caused by a revived prehistoric pathogenic bacterium could be quickly controlled by the modern antibiotics at our disposal,” the researchers wrote, but “the situation would be much more disastrous in the case of plant, animal, or human diseases caused by the revival of an ancient unknown virus.”
However, according to The Washington Post, “Virologists who were not involved in the research said the specter of future pandemics being unleashed from the Siberian steppe ranks low on the list of current public health threats. Most new—or ancient—viruses are not dangerous, and the ones that survive the deep freeze for thousands of years tend not to be in the category of coronaviruses and other highly infectious viruses that lead to pandemics.”
Cornell University virologist Colin Parrish, PhD, President of the American Society for Virology, told The Washington Post that an ancient virus “seems like a low risk compared to the large numbers of viruses that are circulating among vertebrates around the world, and that have proven to be real threats in the past, and where similar events could happen in the future, as we still lack a framework for recognizing those ahead of time.”
Anthony Fauci, MD, former Director of the National Institute of Allergy and Infectious Diseases (NIAID), responded to an earlier study from Claverie’s lab by outlining all the unlikely events that would have to transpire for one of these viruses to cause a pandemic. “The permafrost virus must be able to infect humans, it must then [cause disease], and it must be able to spread efficiently from human to human,” he told The Washington Post in 2015. “This can happen, but it is very unlikely.”
Thus, clinical laboratories probably won’t see new diagnostic testing to identify ancient viruses anytime soon. But it’s always best to remain vigilant.
Dogs’ acute sense of smell can even surpass effectiveness of some clinical laboratory testing in detecting certain diseases in humans
When it comes to COVID-19 testing, a recent Italian study demonstrates that trained dogs can detect SARS-CoV-2 with accuracy comparable to rapid molecular tests used in clinical laboratories. The researchers wanted to determine if dogs could be more effective at screening people for COVID-19 at airports, schools, and other high-traffic environments as a way to detect the coronavirus and reduce the spread of this infectious disease.
Scientists at the State University of Milan in Italy conducted a study that shows dogs can be trained to accurately identify the presence of the COVID-19 infection from both biological samples and by simply smelling an individual.
For their validation study, the Italian team trained three dogs named Nala, Otto, and Helix, “to detect the presence of SARS-CoV-2 in sweat samples from infected people. At the end of the training, the dogs achieved an average sensitivity of 93% and a specificity of 99%, showing a level of accuracy highly consistent with that of the RT-PCR [reverse transcription polymerase chain reaction] used in molecular tests and a moderate to strong reproducibility over time,” Nature reported.
RT-PCR tests are the current gold-standard for SARS-CoV-2 detection. This is yet another example of scientists training dogs to smell a disease with “acceptable” accuracy. This time for COVID-19.
“We only recruited dogs that showed themselves predisposed and positively motivated to carry out this type of activity. One of the fundamental aspects was not to cause stress or anxiety in the subjects used,” Federica Pirrone, PhD (above), Associate Professor, Department of Veterinary Medicine and Animal Sciences, University of Milan, and one of the authors of the study told Lifegate. “Training always takes place using positive reinforcement of a food nature: whether it’s a particularly appetizing morsel, a biscuit, or something that associates the dog’s search with a rewarding prize.” In some instances, dogs have been shown to be as good or more effective at detecting certain diseases than clinical laboratory testing. (Photo copyright: Facebook.)
Dogs More Accurate than Rapid Antigen Testing
Nala and four other dogs (Nim, Hope, Iris and Chaos) were later trained by canine technicians from Medical Detection Dogs Italy (MDDI) to identify the existence of the SARS-CoV-2 virus by directly smelling people waiting in line in pharmacies to get a nasal swab to test for the coronavirus.
Working with their handlers, the five dogs accurately signaled the presence or absence of the virus with 89% sensitivity and 95% specificity. That rate is “well above the minimum required by the WHO [World Health Organization] for rapid swabs for SARS-CoV-2,” according to Nature.
“The results of studies published so far on the accuracy of canine smell in detecting the presence of SARS-CoV-2 in biological samples (e.g., saliva, sweat, urine, trachea-bronchial secretions) from infected people suggest that sniffer dogs might reach percentages of sensitivity and specificity comparable to, or perhaps even higher, than those of RT-PCR,” the scientists wrote in Scientific Reports.
“However, although most of these studies are of good quality, none of them provided scientific validation of canine scent detection, despite this being an important requirement in the chemical analysis practice. Therefore, further applied research in this field is absolutely justified to provide definitive validation of this biodetection method,” the researchers concluded.
Other Studies into Using Dogs for Detecting Disease
Scientists from the Division of Biological and Health Sciences, Department of Agriculture and Livestock at the University of Sonora; and the Canine Training Center Obi-K19, both in Hermosillo, Mexico, conducted the study “as part of a Frontiers of Science Project of the National Council of Science and Technology (CONACYT), in which in addition to analyzing sweat compounds, trained dogs are put to sniff the samples and make detections in people who show symptoms or could be positive for coronavirus,” Mexico Daily Post reported.
The researchers trained four dogs with sweat samples and three dogs with saliva samples of COVID-19 positive patients. The samples were obtained from a health center located in Hermosillo, Sonora, in Mexico. The dogs were restricted to spend five minutes per patient and the researchers calculated the performance of the dogs by measuring sensitivity, specificity, and their 95% confidence intervals (CI).
The researchers concluded that all four of the dogs could detect COVID-19 from either sweat or saliva samples “with sensitivity and specificity rates significantly different from random [sampling] in the field.” According to the Frontiers in Medicine study, the researchers found their results promising because, they said, it is reasonable to expect the detection rate would improve with longer exposure to the samples.
The objective of the Mexican researchers is for the dogs to ultimately reach the sensitivity range requested by WHO for the performance of an antigen test, which is at least 80% sensitivity and 97% specificity. If that goal is achieved, dogs could become important partners in the control of the COVID-19 pandemic, the scientists wrote.
Data obtained so far from these studies indicate that biosensing dogs may represent an effective method of screening for COVID-19 as well as other diseases. More studies and clinical trials are needed before the widespread use of dogs might become feasible. Nevertheless, scientists all over the world are finding that Man’s best friend can be a powerful ally in the fight against the spread of deadly diseases.
In the meantime, the gold standard in COVID-19 testing will continue to be the FDA-cleared assays used by clinical laboratories throughout the United States.
