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Italian Scientists Train Dogs to Detect Presence or Absence of COVID-19 in Humans with Remarkable Accuracy

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.

The researchers published the results of their study in the journal Scientific Reports titled, “Sniffer Dogs Performance is Stable Over Time in Detecting COVID-19 Positive Samples and Agrees with the Rapid Antigen Test in the Field.” Their findings support the idea that biosensing canines could be used to help reduce the spread of the SARS-CoV-2 coronavirus in high-risk environments.

Frederica Pirrone, PhD

“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

In a similar study published in the journal Frontiers in Medicine titled, “Dogs Detecting COVID-19 from Sweat and Saliva of Positive People: A Field Experience in Mexico,” researchers found that dogs could be trained to detect the presence or absence of the SARS-CoV-2 coronavirus from human sweat and saliva samples. 

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. 

In “German Scientists Train Dogs to Detect the Presence of COVID-19 in Saliva Samples; Can a Canine’s Nose Be as Accurate as Clinical Laboratory Testing?Dark Daily reported on a pilot study conducted by researchers at the University of Veterinary Medicine Hannover (TiHo), the Hannover Medical School, and the University Medical Center Hamburg-Eppendorf involving eight specialized sniffer dogs from the Bundeswehr (German armed forces) to determine if the dogs could find people infected with the SARS-CoV-2 coronavirus. After only one week of training, the dogs were able to accurately detect the presence of the COVID-19 infection 94% of the time.

And in “New Study Shows Dogs Can be Trained to Sniff Out Presence of Prostate Cancer in Urine Samples,” we covered how scientists from Johns Hopkins University School of Medicine, University of Texas, Harvard Medical School, Massachusetts Institute of Technology (MIT), and others, had conducted a pilot study that demonstrated dogs could identify prostate samples containing cancer and discern between cancer positive and cancer negative samples.

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.

—JP Schlingman

Related Information:

Sniffer Dogs Performance is Stable Over Time in Detecting COVID-19 Positive Samples and Agrees with the Rapid Antigen Test in the Field

COVID: Goodbye Swabs, the Dogs Will Sniff It

There Are Dogs That Are Able to “Sniff Out” Diseases

Antigen-detection in the Diagnosis of SARS-CoV-2 Infection

Dogs Detecting COVID-19 from Sweat and Saliva of Positive People: A Field Experience in Mexico

German Scientists Train Dogs to Detect the Presence of COVID-19 in Saliva Samples; Can a Canine’s Nose Be as Accurate as Clinical Laboratory Testing?

New Study Shows Dogs Can Be Trained to Sniff Out Presence of Prostate Cancer in Urine Samples

Penn Medicine Researchers Develop Fast, Accurate, Inexpensive COVID-19 Diagnostic Test Based on Electrochemical Technology

The rapid diagnostic test costs less than $5 per unit and can be adapted for other diseases, the developers say, which opens a slew of possibilities for clinical laboratories

Just as the SARS-CoV-2 coronavirus spurred deployment of new vaccine technology based on messenger RNA (mRNA), the COVID-19 pandemic also could prove to be a watershed for in vitro diagnostics (IVD) innovation in ways that benefit clinical laboratories.

In one notable example, researchers at the Perelman School of Medicine University of Pennsylvania (Penn Medicine) in Philadelphia have developed a biosensor that uses electrochemical impedance spectroscopy (EIS) to detect the presence of the COVID-19 coronavirus in biological samples.

A Penn Medicine news release noted that “The RAPID technology … transforms the binding event between the SARS-CoV-2 viral spike protein and its receptor in the human body, the protein ACE2 (which provides the entry point for the coronavirus to hook into and infect human cells), into an electrical signal that clinicians and technicians can detect. That signal allows the test to discriminate between infected and healthy human samples. The signal can be read through a desktop instrument or a smartphone.”

Though still in its early stages, the technique potentially offers dramatically lower costs and faster results than traditional RT-PCR (reverse transcription polymerase chain reaction) molecular tests. Moreover, the RAPID technology might be useful for identifying other types of biomarkers and could be the basis for diagnostic tests that help reduce the cost-per-test in medical laboratory testing while providing comparable sensitivity and specificity to existing methodologies.

Clinical trials began on January 5, 2021, and the Penn Medicine researchers say the IVD test technology can be applied to other infectious diseases, which, if proven accurate, would be a boon to clinical laboratory testing.

The Penn Medicine researchers published their study on May 9 in the journal Matter, titled, “Low-Cost Biosensor for Rapid Detection of SARS-CoV-2 at the Point of Care.”

Diagnostic Test Results in Four Minutes for Less than $5/Test

According to the news release, the RAPID 1.0 (Real-time Accurate Portable Impedimetric Detection prototype 1.0) biosensor test costs less than $5 and can deliver results in four minutes. The researchers reported overall accuracy of 87.1% on (139) nasal swab samples and 90% on (50) saliva samples.

The technology uses electrodes that can be mass-produced at low cost on commercially-available screen printers, the researchers said. Results can be read on electronic devices connected to a PC or smartphone.

RAPID 1.0 COVID-19 diagnostic test

RAPID 1.0 (above) is a low-cost COVID-19 diagnostic test developed at the César de la Fuente clinical laboratory at the Perelman School of Medicine University of Pennsylvania in Philadelphia. At less than $5/test, plus the ability to be adapted to other diseases, clinical laboratories performing disease screenings in rural or remote locations may have a new tool in the fight against infections.  (Photo copyright: University of Pennsylvania.)

Does Penn Medicine’s RAPID 1.0 Test Replace Traditional RT-PCR Testing?

In their published study, the Penn Medicine researchers cited the need for “fast, reliable, inexpensive, and scalable point-of-care diagnostics.”

RT-PCR tests, they said, “are limited by their requirement of a large laboratory space, high reagent costs, multistep sample preparation, and the potential for cross-contamination. Moreover, results usually take hours to days to become available.”

Researchers who have studied the SARS-CoV-2 coronavirus know that it uses a spike-like protein to bind to angiotensin-converting enzyme 2 (ACE2) receptors on the surfaces of human cells.

As described in Penn Medicine’s published study, the biosensor contains ACE2 and other biochemical agents anchored to an electrode. When the SARS-CoV-2 coronavirus attaches to the ACE2, the biosensor transforms the chemical reaction into an electrical signal that can be measured on a device known as a potentiostat.

The researchers tested their RAPID 1.0 technology with two commercially available potentiostat models:

The researchers initially developed the electrode as a printed circuit board, which is relatively expensive. To reduce costs, they constructed a version that uses filter paper as the main component. The researchers noted that one screen printer in a lab can produce 35,000 electrodes per day, including time needed to incorporate the chemical elements. “However, it must be noted that these steps can be fully automated into a production line for industrial purposes, drastically reducing time requirements,” they wrote.

The test can be performed at room temperature, they added, and total cost per unit is $4.67. Much of that—$4.50—is for functionalizing the ACE2 recognition agent. The cost for the bare electrode is just seven cents.

“The overall cost of RAPID may be further reduced through recombinant production of ACE2 and ACE2 variants,” the researchers said, adding that the RAPID 1.0 test can detect the SARS-CoV-2 coronavirus at low concentrations correlating to the earliest stages of the COVID-19 disease.

Cesar de la Fuente, PhD

The Penn Medicine research team was led by César de la Fuente, PhD (above), an Assistant Professor in Psychiatry, Microbiology, Chemical and Biomolecular Engineering and Bioengineering at the Perelman School of Medicine. “Prior to the pandemic, our lab was working on diagnostics for bacterial infections,” he said in the Penn Medicine news release. “But then, COVID-19 hit. We felt a responsibility to use our expertise to help—and the diagnostic space was ripe for improvements.” (Photo copyright: University of Pennsylvania.)

Testing Penn Medicine’s RAPID 1.0 Test

The researchers evaluated the technology in blinded tests with clinical samples from the Hospital of the University of Pennsylvania. The evaluation included 139 nasal swab samples, of which 109 were determined to be COVID-19 positive by RT-PCR tests and clinical assessments. Among these, the RAPID test successfully detected the SARS-CoV-2 coronavirus in 91 samples, for a sensitivity rate of 83.5%. One sample was from a patient diagnosed with the highly contagious SARS-CoV-2 Alpha variant B.1.1.7, which the test correctly identified as positive.

Among the 30 samples determined to be COVID negative, the RAPID test scored a specificity rate of 100%, meaning no false positives. Overall accuracy, including sensitivity and specificity, was 87.1%.

The researchers also analyzed 50 saliva samples: 13 COVID-positive and 37 COVID-negative. The test correctly identified all 13 positive samples but produced five false-positives among the 37 negative samples, for a specificity rate of 86.5%. The researchers speculated that this could be due to interactions between ACE2 and other biomolecules in the saliva but suggested that performance “will improve when using fresh saliva samples at the point-of-care.”

Are There Other Applications for the RAPID Test?

The Penn Medicine news release said the RAPID technology can be adapted to detect other viruses, including those that cause Influenza and sexually-transmitted diseases.

Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, said the test points to one silver lining in the COVID-19 pandemic. “Researchers around the world intensified their work to find ways to identify the SARS-CoV-2 virus that are faster, cheaper, and more accurate than the diagnostic technologies that existed at the time of the outbreak. In this regard, the COVID-19 pandemic may have accelerated the development and refinement of useful diagnostic technologies that will disrupt long-established methods of testing.”

Marcelo Der Torossian Torres, PhD, postdoctoral researcher at Penn Medicine and lead author of the study, said in the news release, “Quick and reliable tests like RAPID allow for high-frequency testing, which can help identify asymptomatic individuals who, once they learn they are infected, will stay home and decrease spread. 

“We envision this type of test being able to be used at high-populated locations such as schools, airports, stadiums, companies—or even in one’s own home,” he added.

Clinical laboratory managers may want to stay current on the development and possible commercialization of the RAPID 1.0 (Real-time Accurate Portable Impedimetric Detection prototype 1.0) biosensor test by the research team at Penn Medicine.

—Stephen Beale

Related Information

Low-Cost Biosensor for Rapid Detection of SARS-CoV-2 at the Point of Care

Rapid COVID-19 Diagnostic Test Delivers Results within Four Minutes with 90% Accuracy

UPenn Medical School Develops Low Cost COVID-19 Test Called RAPID

UPenn Working on Rapid COVID Test That Delivers Results Within Minutes

Rapid COVID-19 Test Developed at Penn Could Give On-the-Spot Results Quickly

One Step Closer to An At-Home, Rapid COVID-19 Test

FDA Authorizes First At-Home COVID-19 Antigen Tests, but Roadblocks Remain for “Fast-and-Frequent” Antigen Testing

Developers of medical laboratory tests had high hopes that cheap saliva-based tests would compete with at-home OTC tests that use nasal swabs, but skepticism among scientists continues

Reverse-transcription polymerase chain reaction (RT-PCR) technology has become the standard for clinical laboratory diagnostic testing used to detect the presence of the SARS-CoV-2 coronavirus. However, to enable more widespread testing, some public health experts have called for deployment of cheap, rapid, saliva-based antigen tests that could be self-administered by consumers in their homes.

Despite the technology’s lower sensitivity compared with RT-PCR testing, the idea of “fast-and-frequent” universal antigen testing has gained support as a possible game-changer against the outbreak, the New York Times reported.

The FDA recently took a step in this direction with its first emergency use authorization for the Ellume COVID-19 at-home antigen test. But other developments suggest that these tests may fall short of the lofty vision initially outlined by the experts.

Ellume’s COVID-19 Home Test
Ellume’s COVID-19 Home Test (above) received emergency use authorization from the FDA on December 15. In a press release, Ellume claimed its rapid-antigen test, “demonstrated a sensitivity of 96% and specificity of 100%, and in asymptomatic individuals, the test demonstrated a sensitivity of 91% and specificity of 96%. This level of accuracy across both symptomatic and asymptomatic individuals is crucial in mitigating the spread of an infectious disease like COVID-19.” (Photo copyright: Ellume.)

The Promise of Rapid Antigen COVID-19 Tests

In a column he wrote for Time in July, Ashish K. Jha, MD, MPH, a practicing General Internist and Dean of the Brown University School of Public Health, described the promise of rapid antigen tests. “Imagine spitting on a special strip of paper every morning and being told two minutes later whether you were positive for COVID-19,” he wrote. “If everyone in the United States did this daily, we would dramatically drop our transmission rates and bring the pandemic under control.”

Another advocate for this approach is Michael Mina, MD, PhD, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health and a core member of the School’s Center for Communicable Disease Dynamics (CCDD). In a commentary for Time in November he wrote, “Widespread and frequent rapid antigen testing (public health screening to suppress outbreaks) is the best possible tool we have at our disposal today—and we are not using it.”

However, one major issue with antigen testing is sensitivity. “Antigen tests require higher levels of virus than qPCR [quantitative polymerase chain reaction] to return a positive result,” Jha wrote in Time. However, he contends, “the frequency of testing and the speed of results” counter concerns about accuracy.

Even with lower sensitivity, Jha wrote, the quicker test results from antigen tests “would identify viral loads during the most infectious period, meaning those cases we care most about identifying—at the peak period of infectiousness—are less likely to be missed.”

As the FDA explains, RT-PCR molecular tests “detect the virus’ genetic material,” whereas, according to an article published in Nature, titled, “Fast Coronavirus Tests: What They Can and Can’t Do,” antigen tests can “detect specific proteins … on the surface of the virus, and can identify people who are at the peak of infection, when virus levels in the body are likely to be high.”

At-Home Antigen Tests Receive EUAs

The new antigen test developed by Ellume is “the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19,” the FDA said in a press release. The user self-administers a nasal swab and places it in an analyzer connected to a smartphone app. It can deliver results in 20 minutes. The company states that its test has overall sensitivity of 95% and specificity of 97% based on a clinical study of 198 subjects in a simulated home setting.

Jeffrey Shuren, MD, JD, Director of FDA’s Center for Devices and Radiological Health, said in the FDA press release, “This test, like other antigen tests, is less sensitive and less specific than typical molecular tests run in a lab. However, the fact that it can be used completely at home and return results quickly means that it can play an important role in response to the pandemic.”

Ellume expects to deliver about 20 million tests to the US by the end of June 2021. Multiple outlets reported that the test will cost about $30, AP News reported.

Meanwhile, the FDA also authorized at-home use of Abbott’s BinaxNOW rapid antigen test, which was previously authorized for use in point-of-care settings. This test, which requires a prescription, will sell for $25.

In a series of tweets, Harvard’s Mina applauded both moves, but he wrote that they [antigen tests] still fall short of his vision for fast and frequent testing. He described Abbott’s BinaxNOW as “the type of rapid test I have been calling for,” but said he’d like to see tests priced far less and available without a prescription.

Diminishing Prospects for Saliva-based Antigen Tests?

All rapid antigen tests authorized by the FDA so far require nasopharyngeal and/or nasal swab specimens, and it appears that it may be a long time, if ever, before saliva-based antigen tests are available. The New York Times (NYT) reported in October that two companies working on antigen tests—E25Bio and OraSure (NASDAQ:OSUR)—have dropped plans to enable use of saliva.

E25Bio founder Bobby Brooke Herrera, PhD with E25Bio co-founder and Chief Technology Officer Irene Bosch
“If I was placing a bet—which I am, because I’m leading an antigen-based testing company—I would say it’s going to be very difficult for antigen-based testing to work on saliva samples,” E25Bio founder Bobby Brooke Herrera, PhD (above with E25Bio co-founder and Chief Technology Officer Irene Bosch) told the NYT. (Photo copyright: WCVB-TV.)

One advantage of a saliva-based test is that it would be easier to self-administer. “But as they continued to tinker with their tests, researchers at both E25Bio and OraSure found saliva’s performance to be more lackluster than anticipated, and were forced to pivot,” the New York Times reported. Instead, both companies will seek authorization for use of their tests with nasal swabs.

HHS Contract for Antigen Tests Brings High Rates of False Positives

A recent investigative story in ProPublica, titled, “Rapid Testing Is Less Accurate than the Government Wants to Admit,” raised additional questions about rapid antigen testing. In August, the US Department of Health and Human Services announced it had awarded a $760 million contract for 150 million Abbott BinaxNOW tests to be distributed to schools and nursing homes. But later, according to ProPublica, healthcare workers in Nevada and Vermont reported high rates of false positives.

“With the benefit of hindsight, experts said the Trump administration should have released antigen tests primarily to communities with outbreaks instead of expecting them to work just as well in large groups of asymptomatic people,” ProPublica reported. “Understanding they can produce false results; the government could have ensured that clinics had enough for repeat testing to reduce false negatives and access to more precise PCR tests to weed out false positives.”

A few weeks after the reports from Nevada and Vermont, the FDA issued a letter advising clinical laboratories and healthcare providers about the possibility of false positives, along with steps they could take to improve accuracy.

Though some experts remain hopeful about “fast-and-frequent” testing, others are skeptical and say more research is needed to assess the value of this approach. “We are open to thinking outside the box and coming up with new ways to handle this pandemic,” Esther Babady PhD, D(ABMM) of Memorial Sloan Kettering Cancer Center, told the New York Times. However, she added, “the data for that is what’s missing.”

Nevertheless, were at-home rapid saliva-based antigen tests to become a common choice for healthcare consumers, clinical laboratories that perform RT-PCR testing for COVID-19 could see a marked decrease in orders. Thus, regardless of the current state of antigen testing, its development is worth watching.

—Stephen Beale

Related Information:

How We Can Stop the Spread of COVID-19 by Christmas

Over-the-Counter Home Test for COVID-19 Gets US Green Light

‘A Major Breakthrough’: FDA Authorizes Nation’s First At-Home, Over-the-Counter COVID-19 Test

FDA Authorizes First Rapid, Over-the-Counter Home Coronavirus Test

Rapid Testing Is Less Accurate than the Government Wants to Admit

Daily Coronavirus Testing at Home? Many Experts Are Skeptical

Home Tests Could Help in the Fight Against the Coronavirus. So Where Are They?

Screening to Prevent SARS-CoV-2 Outbreaks: Saliva-Based Antigen Testing Is Better than the PCR Swab

America Needs to Radically Rethink Our COVID-19 Testing Approach

Test Sensitivity Is Secondary to Frequency and Turnaround Time for COVID-19 Surveillance

Abbott COVID-19 Tests at Center of Squabble Between Trump Administration, States

Millions of Rapid COVID-19 Antigen Tests May Help Fill the Testing Gap

Workplaces Must Screen Employees for COVID-19, Say Authorities in the US and Ontario, and This Trend Could Mean Big Business for Clinical Laboratories

As mandatory screenings for private industry workers increases, some states launch free COVID-19 testing for state employees, while engaging medical laboratories to provide such testing

Amid the SARS-CoV-2 pandemic, welcoming employees back to work is not as simple as opening the company’s doors. Businesses based in some areas of the US and Canada are being required by state and provincial governments to conduct employee COVID-19 screenings. For clinical laboratories, the increase in mandatory screening programs could mean an expanding market for employee testing programs and opportunities for lab outreach programs.

But companies and medical laboratories may also face legal and regulatory risks as workplaces reopen and people return.

For example, how do clinical laboratory managers ensure their labs have the information they need to respond to new rules and regulations, and do employers have recourse should an employee receive a COVID-19 test report with an incorrect result?

Not COVID-19 Screening Can Lead to Fines, Imprisonment

In Ontario, under O. Reg. 364/20: Rules for Areas in Stage 3, an amendment to the Reopening Ontario (A Flexible Response to COVID-19) Act, 2020, S.O. 2020, c. 17, workplaces are required to screen employees and visitors for COVID-19 before they enter office buildings, the Society for Human Resource Management (SHRM) reported.

An Ontario Ministry of Health COVID-19 Screening Tool for Workplaces (Businesses and Organizations) instructs businesses on questions to ask of “workers” and “essential visitors” who are being screened before entering a workplace. They include:

  • Is there existence of “new or worsening symptoms,” such as fever or chills, difficulty breathing, and cough?
  • Has the employee travelled outside Canada in the past 14 days?
  • Has the employee had close contact with other confirmed or “probable” COVID-19 cases?

A “probable” case is “a person with symptoms compatible with COVID-19 AND in whom laboratory diagnosis of COVID-19 is inconclusive,” according to a blog post by Justin P’ng, Employment and Labor Lawyer/Associate at international law firm Fasken in Toronto.

“Employers [in Ontario] must now specifically comply with the requirements of the Screening Tool and to implement such screening at any physical workplaces it operates in the province,” P’ng wrote. “Failure to comply can lead to significant penalties, including potentially fines and imprisonment under the legislation.”

It is possible the new requirements may ease Ontario workers’ minds about heading back to work during the pandemic. A Canadian workforce survey of employers and employees during July 2020 by PricewaterhouseCoopers (PwC) Canada found:

  • Most employers (78%) expect a return to the workplace in 2020.
  • Just one in five employees indicated they want to go back to the workplace full-time.

Michigan Makes Remote Work Mandatory

In the US, state rules enforced by the Michigan Occupational Safety and Health Administration (MIOSHA) require employers—for infection prevention reasons—to establish remote work programs for employees, unless it is not feasible for employees to work away from the workplace.

“The employer shall create a policy prohibiting in-person work for employees to the extent that their work activities can feasibly be completed remotely,” MIOSHA said.

Similar to the Ontario law, Michigan employers are also required to establish COVID-19 screenings. The MIOSHA rules direct employers to “conduct a daily entry self-screening protocol for all employees or contractors entering the workplace, including, at a minimum, a questionnaire covering symptoms and suspected or confirmed exposure to people with possible COVID-19, together with, if possible, a temperature screening.”

Michigan employers not in compliance with the state’s requirements for office work may be fined up to $7,000 per violation, a McDonald Hopkins Insights article noted.

Furthermore, anti-retaliation law in Michigan prohibits employers from terminating or “retaliating against” employees who oppose violation of the law or report COVID-19 “health violations,” the McDonald Hopkins Insights article added.

However, Michigan businesses may have protection under the COVID-19 Response and Reopening Liability Assurance Act. The law states a “person who acts in compliance with all federal, state, and local statutes, rules, regulations, executive orders, and agency orders related to COVID-19 that had not been denied legal effect at the time of the conduct or risk that allegedly caused harm is immune from liability for a COVID-19 claim.”

The law defines a “person” as “an individual, partnership, corporation, association, governmental entity, or other legal entity, including, but not limited to, a school, a college or university, an institution of higher education, and a nonprofit charitable organization. Person includes an employee, agent, or independent contractor of the person, regardless of whether the individual is paid or an unpaid volunteer.”

New York Launches Free RT-PCR Tests for Transit Employees

Meanwhile, in New York, free COVID-19 tests are now available on a voluntary basis to 2,000 frontline employees of the Metropolitan Transit Authority, a news release states.

BioReference Laboratories and Quest Diagnostics are performing the RT-PCR testing.

“Quality COVID-19 testing is critical to helping our nation’s frontline workers do their jobs as safely as possible,” Wendi Mader, Executive Director of Employer Population Health at Quest Diagnostics, said in the news release.

New Special Report Available on COVID-19 Employee Testing Programs

As the SARS-CoV-2 pandemic progresses, laws, regulations, and rules pertaining to COVID-19 employee testing and screening will likely continue to develop—and they will vary by area and by test type—making them a challenge to interpret, track, and ensure compliance.

Thus, to help medical laboratory managers and human resources professionals receive the critical, relevant information they need prior to launching COVID-19 testing programs, the Dark Intelligence Group has published a special report, titled, “How to Develop a COVID-19 Employee Testing Program: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues for Clinical Laboratories and Employers.”

Dark Daily Special Report - Covid-19 Employee Testing Program
This exclusive report offers guidance, best practices, and insights necessary to launch and operate high quality, compliant COVID-19 employee testing programs. Clinical laboratories and employers tasked with developing and maintaining coronavirus testing programs will gain critical insights and data from this invaluable special report. (Photo copyright: Dark Intelligence Group.)

Included in the report:

  • Ten regulatory essentials for launching a COVID-19 testing program
  • Test eligibility
  • Order requirements
  • Privacy
  • Contractual and liability issues
  • Infection prevention and OSHA compliance
  • Case studies

This information comes from attorneys at numerous law firms, including:

To access this timely and invaluable special report, click here, or go to: https://www.darkdaily.com/product/how-to-develop-a-covid-19-employee-testing-program-what-clinical-laboratories-need-to-know/ to download.

—Donna Marie Pocius

Related Information:

How to Develop A COVID-19 Employee Testing Program: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues for Clinical Laboratories and Employers

COVID-19 Screening is Mandatory in Ontario Workplaces

Ontario Workplaces Now Required to Screen for COVID-19

New Michigan COVID-19 Legislation

COVID-19 Response and Reopening Liability Assurance Act

Gov Cuomo Announces MTA to Launch Voluntary COVID-19 Screening Program for Frontline Employees

Houston High School Student Starts Lab Business and Takes COVID-19 Rapid Antigen Testing on the Road with Mobile Clinical Laboratory

Taft Foley, III, says he got the idea for the mobile lab after waiting on a COVID-19 testing line that went ‘around the entire building’

In a remarkable example of ingenuity and observation, Texas high school student Taft Foley, III, is bringing COVID-19 testing to underserved patients, wherever they may be. He launched a medical lab company, then developed a mobile clinical laboratory which performs rapid antigen tests that can detect the presence of antigen in about 15 minutes.

Foley—who recently became an EMT after graduating from the Texas EMS Academy—designed his mobile medical lab to use Quidel Sofia SARS Antigen FIA tests (nasal swabs). Results are sent to patients by text or e-mail. Foley also works with CLIA-certified Baylor Genetics Laboratories on COVID-19 (SARS-CoV-2) RT-PCR molecular testing, which gives his customers results in 24 to 48 hours, Forbes reported.

Foley, who is 18-years-old and an Eagle Scout, said he got the idea to launch the mobile COVID-19 testing business after he went for a coronavirus test and had to wait on a line that “wrapped around the entire building,” ABC13 reported. “I said to myself, ‘There needs to be a better way,’” Foley told ABC13.

Forbes reported that Texas Mobile Medical Labs allocates a portion of test fees paid ($100 to $150/test) to help provide tests to the homeless and others who need them, such as veterans and senior citizens.

“The (majority of) tests have been done at businesses who appreciate our mobile capabilities. We arrive and test all employees onsite and have their results back in 15 minutes,” Foley told Forbes.

Taft Foley, III and his medical lab van
After raising $60,000 through events and sale of personal items, Taft Foley, III (above), purchased a van and rapid antigen tests, reported The Kinkaid Falcon. “I think that that idea is hopefully going to galvanize a lot of good things, because we as humans, we’re good at learning from one another. If my idea is good enough to inspire others to create their own businesses and ideas for the betterment of the community, then I’m all for it,” Foley told the Falcon. (Photo copyright: Texas Mobile Medical Labs.)

Other States with Mobile COVID-19 Testing

Texas is not the only state where savvy entrepreneurs like Foley and health agencies are offering mobile COVID-19 testing.

In May, Florida Gov. Ron DeSantis announced Statlab Mobile, a COVID-19 mobile laboratory out of Miami that tests people in skilled nursing and long-term care facilities and other areas of the Sunshine State.

“We believe this will be a game-changer (in long-term care),” DeSantis told the Miami Herald.

“The idea was to bring help to those who are vulnerable, those who can’t otherwise get the kind of medical information they would otherwise love to have,” Bryan Wilson, Statlab Chief Executive Officer, told Patch, which noted the tests are free.

Statlab Mobile van
Statlab Mobile (above) can perform about 3,500 Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV coronavirus tests per week, according to the Florida COVID-19 Testing website. Statlab works with Florida’s Division of Emergency Management, the National Guard, and contracted nurses to conduct coronavirus testing throughout Florida. (Photo copyright: Statlab Mobile.)

Mobile COVID Testing in Other States

Mobile medical laboratories are being deployed to help handle surges of COVID-19 cases in Massachusetts, New Jersey, and Arizona, as well.

In Massachusetts, testing vans operated by American Family Care (AFC), an urgent care provider, started heading out in November to schools and businesses state-wide with a goal to test at least 100 to 150 people daily for COVID-19, according to The Reminder.

The vans are staffed by medical providers who test people with Abbott’s BinaxNOW COVID-19 Ag Card, AFC told The Reminder. The rapid antigen test offers results in 15 minutes.

In September, Dark Daily reported that the US federal Department of Health and Human Services (HHS) awarded a $760 million contract to Abbott for 150 million rapid antigen tests to aid in detection of COVID-19 as workplaces and schools reopen.

“We’ve had several companies who would like to schedule their employees to be tested on a regular basis. But they also want to be able to make sure that if there is a potential contamination within their businesses, they have a resource to utilize to make sure they can test people right away,” Jim Brennan, Owner/CEO of Medvest, LLC, AFC urgent care’s parent company, told The Reminder.

And in Phoenix, a COVID-19 mobile medical van provides testing to underserved communities. The City of Phoenix, along with staff from the Vincere Cancer Center, use Quidel’s Sofia SARS Antigen FIA test at public and private locations and at family services centers, AZ Central reported.

Clearly, mobile COVID-19 testing labs are here to stay. They serve seniors and vulnerable populations challenged to access clinical laboratory testing at traditional locations and at COVID-19 drive-through sites. And on larger scales, mobile medical laboratories have become key resources to address coronavirus case surges and to conveniently test people at businesses and schools to help identify symptomatic individuals who should be quarantined.

Clinical laboratory managers may be impressed by how quickly mobile testing companies and entrepreneurs form partnerships with public health agencies toward making COVID-19 tests available to all at places where people live and work.

—Donna Marie Pocius

Related Information:

Houston Teen Launches Mobile COVID-19 Testing Lab

Texas EMT, 18, Opens Mobile COVID-19 Testing Lab

Taft Foley III, 18-Year-Old, Makes Mobile COVID-19 Testing Lab

TAFT Foley, ’21, Creates Mobile COVID-19 Testing Center

DeSantis Announces New COVID-19 Antibody Testing, Sanitizing and Lab on Wheels

Fast Coronavirus Lab Results in Florida Through Statlab Mobile

AFC Deploys COVID-19 Mobile Testing Vans in Community

Free Phoenix COVID-19 Mobile Testing Van Gives Results in 15 Minutes

U.S. Government Purchases 150 Million COVID-19 Antigen Tests from Abbott Laboratories for $760 Million; Only CLIA-Certified Laboratories Can Do Testing

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