BioReference Laboratories’ Unique Journey during the COVID-19 Pandemic Described in ‘Swab,’ a New Book by former BRLI CEO Jon Cohen, MD

Certainly every clinical laboratory in the United States has a unique story about dealing with the challenges of the SARS-CoV-2 outbreak, but only BioReference did testing for multiple professional sports leagues and the cruise ship industry

Few would challenge the assertion that the nation’s clinical laboratories (along with public health officials) were caught flat-footed when the SARS-CoV-2 coronavirus reached the United States in the winter of 2021. Even as the federal Centers for Disease Control and Prevention (CDC) and some labs rushed to develop reliable medical laboratory tests for COVID-19 in the early weeks of the outbreak, the demand for tests far outstripped supply in this country for many months.

This was the moment when the pandemic’s need meant lab testing opportunity for medical laboratories across the nation. This was particularly true for Elmwood Park, New Jersey-based BioReference Laboratories, Inc. (BRLI), a division of OPKO, Inc. BioReference found itself in the nation’s first pandemic hot zone—New York City and surrounding counties.

Not only was this lab company geographically in the center of the first overwhelming surge of COVID-19 cases, but its management team had important relationships across government and business. For that reason, its management team was pulled into the earliest planning sessions by government officials at the city, state, and federal level.

Consequently, in the earliest days of the outbreak, BioReference was one of the nation’s first labs to help organize and support drive-through COVID-19 specimen collection centers. Its management team went on to accomplish many notable firsts in the lab’s response to the pandemic. All of this is described in the recently-published book “Swab–Leadership in the Race to Provide COVID Testing to America.”

As CEO of BioReference Laboratories during the time of the COVID-19 pandemic in 2020 and 2021, physician Jon R. Cohen, MD (above), energized his clinical lab’s management team and staff to rise to a series of unique challenges, ranging from helping set up the nation’s first drive-through COVID-19 sampling sites in New York City to performing testing for professional sports leagues, such as the NBA, the NFL, and the NHL. (Photo copyright: New York Foundling, Inc.)

Harnessing the Creativity and Energy of a Clinical Lab Staff

The book’s author is Jon R. Cohen, MD, who was CEO of BioReference Laboratories throughout the course of the pandemic. Cohen is now CEO of Talkspace, a virtual behavioral health company.

“Swab” documents BioReference lab’s response to the SARS-CoV-2 pandemic and tells the tale of how the lab company harnessed the creativity of its managers and lab scientists to speedily build up daily test volumes at a time when automation, analyzers, test kits, collection supplies, and reagents were in short supply.

Clinical laboratory professionals interested in lab management will gain valuable insights from Cohen’s approach to writing “Swab.”

While describing BioReference lab’s many innovative COVID-19 testing services, Cohen also provides readers with the management lessons and insights he used to impart needed skills to the company managers, while also inspiring BioReference Lab’s staff to devote the extra effort necessary to deliver COVID-19 testing in novel ways and in unusual settings.

When New York City hospitals were overwhelmed by cases in the earliest days of the pandemic, Cohen’s personal contacts with political leaders came into play. Just a few years earlier, Cohen had run for statewide office as a Democrat. He had friendships with the New York City Mayor Bill de Blasio, with the New York State Governor Mario Cuomo, and with Senators Charles Schumer and Kirsten Gillibrand.

Cohen’s Lab Had a Seat at Government Planning Tables

As these government officials convened various task forces to address the pandemic, Cohen describes how BioReference had a seat at the table and a voice in viable ways to organize specimen collection and COVID-19 testing literally overnight and on an unprecedented scale.

The pandemic’s early days in late February, March, and April of 2020 were only the first challenges to be overcome by the management at BioReference. “Swab” describes a remarkable progression of innovative SARS-CoV-2 testing programs initiated by Cohen and his team. Each of these testing programs was tailored to the specific needs of different industries. No other clinical laboratory organization in the United States was as successful at serving this range of clients. For example:

  • For the last eight games of the National Basketball Association’s 2020 season and playoffs, BioReference created and managed the NBA’s “biosecure bubble” program at Disney World in Orlando. Over the course of 172 games, 150,000 SARS-CoV-2 tests were performed with zero-positivity.
  • The National Football League watched the NBA play in its bubble that summer. BioReference got the call and worked with NFL management to provide COVID-19 tests. For the 2020 season, in support of 268 games played across the United States, BioReference performed 1.23 million tests for 5,000 players, coaches, and staff, with an infection rate of less than 1%.
  • Along with the NBA and NFL, BioReference provided SARS-CoV-2 testing for professional soccer and hockey, the Winter X Games, and the US men’s and women’s Olympic soccer teams.
  • One of the lab company’s more complex SARS-CoV-2 testing programs involved the cruise ship industry. In 2021, BioReference established sites in 13 ports around the US and the Caribbean. The lab placed staff on as many as 24 cruise ships at one time.
  • Of course, testing for schools, colleges, universities, and employers was part of BRLI’s testing services over the course of the COVID-19 pandemic as well.

Creativity of Clinical Lab Managers and Staff

As the examples above illustrate, “Swab” will give readers a ringside seat in how BioReference Laboratories harnessed the creativity and skills of its management team and staff to address the unprecedented demands for timely, accurate COVID-19 testing from the very beginning of the pandemic through its waning months.

Cohen writes with an accessible style and provides readers with an easy-to-read narrative of his lab company’s journey through the pandemic. Each of the book’s 10 chapters ends with a “Leadership Reflection” that Cohen uses to describe the management methods he utilized to keep BRLI’s thousands of employees on task and on time, so that the end result month after month was “mission accomplished.”

In today’s digital age, the statement “this book is available at a bookstore near you” may not be applicable. What is true is that author Jon R. Cohen’s “Swab–Leadership in the Race to Provide COVID Testing to America” can be ordered at,, and other web-based booksellers. 

—Robert L. Michel

Related Information:

Company Testing NBA Players in Bubble Seeks ‘Greater Good’

The Lab Powering Pandemic Sports

NBA to Primarily Use Rapid Tests for COVID-19 in 2021-22

NFL COVID-19 Testing Program Avoids Using Local Resources, Medical Personnel

BioReference Laboratories Capitalizes on Increasing Demand for Rapid POC SARS-CoV-2 Tests

NFL COVID-19 Testing Program Avoids Using Local Resources, Medical Personnel

The NBA Bubble Is Safe So Far. But the League’s Lessons Won’t Work for Schools and Businesses

UK Researchers Create Conductive Thread That Can Be Woven into Clothing to Monitor Key Health Biomarkers

Meet ‘PECOTEX,’ a newly-invented cotton thread with up to 10 sensors that is washable. Its developers hope it can help doctors diagnosis disease and enable patients to monitor their health conditions

Wearable biosensors continue to be an exciting area of research and product development. The latest development in wearable biosensors comes from a team of scientists led by Imperial College London. This team created a conductive cotton thread that can be woven onto T-shirts, textiles, and face masks and used to monitor key biosignatures like heart rate, respiratory rate, and ammonia levels.

Clinical laboratory managers and pathologists should also take note that this wearable technology also can be used to diagnose and track diseases and improve the monitoring of sleep, exercise, and stress, according to an Imperial College London news release.

Should this technology make it into daily use, it might be an opportunity for clinical laboratories to collect diagnostic and health-monitoring data to add to the patient’s full record of lab test results. In turn, clinical pathologists could use that data to add value when consulting with referring physicians and their patients.

The researchers published their findings in the journal Materials Today titled, “PEDOT:PSS-modified Cotton Conductive Thread for Mass Manufacturing of Textile-Based Electrical Wearable Sensors by Computerized Embroidery.”

“Our research opens up exciting possibilities for wearable sensors in everyday clothing,” said Firat Güder, PhD, Principal Investigator and Chief Engineer at Güder Research Group at Imperial College London, in a news release. “By monitoring breathing, heart rate, and gases, they can already be seamlessly integrated, and might even be able to help diagnose and monitor treatments of disease in the future.” (Photo copyright: Wikipedia.)

Ushering in New Generation of Wearable Health Sensors

The researchers dubbed their new sensor thread PECOTEX. It’s a polystyrene sulfonate-modified cotton conductive thread that can incorporate more than 10 sensors into cloth surfaces, costs a mere 15 cents/meter (slightly over 39 inches), and is machine washable.

“PECOTEX is high-performing, strong, and adaptable to different needs,” stated Firat Güder, PhD, Principal Investigator and Chief Engineer at Güder Research Group, Imperial College London, in the press release.

“It’s readily scalable, meaning we can produce large volumes inexpensively using both domestic and industrial computerized embroidery machines,” he added.

The material is less breakable and more conductive than conventional conductive threads, which allows for more layers to be embroidered on top of each other to develop more complex sensors. The embroidered sensors retain the intrinsic values of the cloth items, such as wearability, breathability, and the feel on the skin. PECOTEX is also compatible with computerized embroidery machines used in the textile industry.

The researchers embroidered the sensors into T-shirts to track heart activity, into a face mask to monitor breathing, and into other textiles to monitor gases in the body like ammonia which could help detect issues with liver and kidney function, according to the news release.

“The flexible medium of clothing means our sensors have a wide range of applications,” said Fahad Alshabouna, a PhD candidate at Imperial College’s Department of Bioengineering and lead author of the study in the news release. “They’re also relatively easy to produce which means we could scale up manufacturing and usher in a new generation of wearables in clothing.”

Uses for PECOTEX Outside of Healthcare

The team plans on exploring new applications for PECOTEX, such as energy storage, energy harvesting, and biochemical testing for personalized medicine. They are also seeking partners for commercialization of the product.

“We demonstrated applications in monitoring cardiac activity and breathing, and sensing gases,” Fahad added. “Future potential applications include diagnosing and monitoring disease and treatment, monitoring the body during exercise, sleep, and stress, and use in batteries, heaters, and anti-static clothing.”

In addition to Imperial College London, the research was funded by the Saudi Ministry of Education, the Engineering and Physical Sciences Research Council (EPSRC), Cytiva Life Sciences, the Bill and Melinda Gates Foundation, and the US Army.

Other Wearable Biometric Sensors

Dark Daily has covered the development of many wearable health sensors in past ebriefings.

In “UC San Diego Engineers Develop Microneedle Wearable Patch That Measures Glucose, Alcohol, Muscle Fatigue in Real Time,” we covered how “lab-on-the-skin” multi-tasking microneedle sensors like the one developed at the University of California San Diego’s (UCSD) Center for Wearable Sensors to track multiple biomarkers in interstitial fluid were finding their way into chronic disease monitoring and sample collecting for clinical laboratory testing.

In “Fitbit Receives FDA Approval for a Wearable Device App That Detects Atrial Fibrillation,” we reported how personal fitness technology company Fitbit had received 510(k) clearance from the US Food and Drug Administration (FDA), as well as Conformité Européenne (CE marking) in the European Union, for its Sense smartwatch electrocardiogram app that monitors wearers’ heart rhythms for atrial fibrillation (AFib).

And in “Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults,” we reported how researchers at Tokyo University of Science (TUS) had created a self-powered, glucose-testing diaper that utilizes a biofuel cell to detect the presence of urine and measure its glucose concentration.

Wearable Sensors in Personalized Healthcare

Wearable healthcare devices have enormous potential to perform monitoring for diagnostic, therapeutic, and rehabilitation purposes and support precision medicine.

Further studies and clinical trials need to occur before PECOTEX will be ready for mass consumer use. Nevertheless, it could lead to new categories of inexpensive, wearable sensors that can be integrated into everyday clothes to provide data about an individual’s health and wellbeing.

If this technology makes it to clinical use, it could provide an opportunity for clinical laboratories to collect diagnostic data for patient records and help healthcare professionals track their patients’ medical conditions. 

—JP Schlingman

Related Information:

Sensors Embedded into T-Shirts and Face Masks Could Monitor Biosignatures

PEDOT:PSS-modified Cotton Conductive Thread for Mass Manufacturing of Textile-based Electrical Wearable Sensors by Computerized Embroidery

Wearable Sensors Styled into T-shirts and Face Masks

Low-Cost Sensor Tracks Vital Signs and Breath to Monitor Diseases

Sensor Thread

Wearable Sensor

UC San Diego Engineers Develop Microneedle Wearable Patch That Measures Glucose, Alcohol, Muscle Fatigue in Real Time

Fitbit Receives FDA Approval for a Wearable Device App That Detects Atrial Fibrillation

Researchers in Japan Have Developed a ‘Smart’ Diaper Equipped with a Self-powered Biosensor That Can Monitor Blood Glucose Levels in Adults

NHS Trial Analysis Finds That Grail’s Galleri Clinical Laboratory Blood Test Can Detect 50 Cancers and Identify the Location of the Cancer

Though a ‘work in progress,’ the Oxford researchers who conducted the trail believe the MCED blood test could help doctors give better cancer assessments

Cancer is typically diagnosed through tissue biopsies that are often invasive and painful for patients. Now, recently-released results of a National Health Service (NHS) trial study of a relatively new multi-cancer early detection test (MCED) may provide a less painful/invasive cancer test experience to UK residents.

Developed by California-based healthcare technology company Grail, the clinical laboratory blood test—called Galleri—can detect 50 cancer types and, according to the company’s website, even identify the cancer’s location within the body. It is currently only available through a doctor’s prescription.

Researchers have long sought to improve screening methods and diagnostic technologies that identify cancers more easily and at an earlier stage. They recognize that a simple, inexpensive laboratory blood test—as opposed to a tissue biopsy—that detects both the presence of multiple cancer types and its location would benefit both medical professionals and patients worldwide.

The NHS trial study of the Galleri MCED test—dubbed SYMPLIFY—began in 2021. It is “a collaboration between the University of Oxford’s Department of Oncology, the Cancer Research Group at the Nuffield Department of Primary Care Health Sciences, the Oncology Clinical Trials Office, and the Primary Care Clinical Trials Unit,” according a 2021 University of Oxford press release.

The researchers published their findings in The Lancet Oncology titled, “Multi-cancer Early Detection Test in Symptomatic Patients Referred for Cancer Investigation in England and Wales (SYMPLIFY): a Large-scale, Observational Cohort Study.”

“The [Galleri] test was 85% accurate in detecting the source of the cancer, and that can be really helpful because so many times it is not immediately obvious when you have got the patient in front of you what test is needed to see whether their symptoms are down to cancer,” said Mark Middleton, MD, PhD, head of the Department of Oncology at the University of Oxford and lead researcher of the study, in a BBC interview. (Photo copyright: University of Oxford.)

Details of the SYMPLIFY Study

To conduct the SYMPLIFY study, Oxford researchers enrolled 6,238 adults in England and Wales who were referred for imaging and diagnostic testing with symptoms that were indicative of gynecological, lung, or lower/upper GI cancers, or with non-specific symptoms. The most commonly reported symptoms that triggered the referrals were:

  • Weight loss (24.1%)
  • Change in bowel habits (22.0%)
  • Post-menopausal bleeding (16.0%)
  • Rectal bleeding (15.7%)
  • Abdominal pain (14.5%)
  • Pain (10.6%)
  • Difficulty swallowing (8.8%)
  • Anemia (7.1%)

DNA from cancer cells—called ctDNA (circulating tumor DNA)—can be detected in blood samples at early tumor stages. The Galleri MCED test was performed on cell-free DNA taken from blood samples provided by the study participants. The test was performed in batches and blinded to results of previous diagnostic tests.

The predictions of the test were then compared to diagnoses received via traditional diagnostic testing and imaging. 

According to the Oxford researchers’ Lancet paper, GRAIL’s MCED test detected a cancer signal in 323 of the study participants. Of those individuals, 244 received a cancer diagnosis, resulting in a positive predictive value (PPV) of 75.5%, a negative predictive value (NPV) of 97.6%, and a specificity of 98.4%.

The overall sensitivity of the Galleri test was 66.3%, representing a range from 24.2% in Stage 1 cancers to 95.3% in stage IV cancers. The mean age of the study participants was 62.1 years old, and the sensitivity increased with age and cancer stage.

The overall accuracy of the top Cancer Signal Origin (CSO) prediction following a positive MCED test was 85.2%, the researchers concluded.

“With that prediction from the test, we can decide whether to order a scope or a scan and make sure we are giving the right test the first time,” Mark Middleton, MD, PhD, head of the Department of Oncology at the University of Oxford and lead researcher of the study, told BBC News.

The most common cancers detected among the study participants were:

“Earlier cancer detection and subsequent intervention has the potential to greatly improve patient outcomes. Most patients diagnosed with cancer first see a primary care physician for the investigation of symptoms suggestive of cancer, like weight loss, anemia, or abdominal pain, which can be complex as there are multiple potential causes,” said Brian Nicholson, DPhil, Associate Professor at Oxford’s Nuffield Department of Primary Care Health Sciences and co-lead investigator for the study in a 2023 Oxford press release. “New tools that can both expedite cancer diagnosis and potentially avoid invasive and costly investigations are needed to more accurately triage patients who present with non-specific cancer symptoms.

“The high overall specificity, positive predictive value, and accuracy of the cancer signal detected and cancer signal origin prediction that was reported across cancer types in the SYMPLIFY study indicate that a positive MCED test could be used to confirm that symptomatic patients should be evaluated for cancer before pursuing other diagnoses,” he added.

MCED Test May Help Doctors Better Assess Cancer

The SYMPLIFY study is the first large-scale analysis of an MCED test in patients who were referred by their doctors for diagnostic testing due to suspected cancers. The results of the study were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June.

Middleton told BBC News that the test is not yet accurate enough to “rule in or rule out cancer,” but it was useful for researchers and patients.

“The findings from the study suggest this test could be used to support GPs to make clinical assessments but much more research is needed, in a larger trial, to see if it could improve GP assessment and ultimately patient outcomes,” David Crosby, PhD, head of Prevention and Early Detection Research, Cancer Research, UK, told BBC News.

Scientists at the University of Oxford were responsible for data collection, analysis, and interpretation of the data used for the study. The study was funded by GRAIL with support from National Health Service England (NHS), NHS Wales, the National Institute for Health and Care Research (NIHR), and the NIHR Oxford Biomedical Research Centre

Clinical laboratories and anatomic pathology groups that perform tissue biopsy testing for oncologists will want to monitor the progress of this simple blood test that may someday reduce the number of invasive, painful biopsies required to diagnose cancer and other health considerations.

—Jillia Schlingman

Related Information:

Multi-cancer Early Detection Test in Symptomatic Patients Referred for Cancer Investigation in England and Wales (SYMPLIFY): a Large-scale, Observational Cohort Study

Multi-cancer Blood Test Shows Real Promise in NHS Study

Multi-cancer Blood Test Shows Real Promise in NHS Trial

SYMPLIFY: Observational Study to Assess a Multi-Cancer Early Detection Test in Individuals Referred with Signs and Symptoms of Cancer

Galleri: The First Clinically-validated MCED Test

GRAIL and University of Oxford to Present Results from First Prospective Study of Multi-Cancer Early Detection in a Symptomatic Patient Population at 2023 ASCO Annual Meeting

British Medical Laboratory Test for Early Screening of Lung Cancer Shows Promising Interim Results in Large Trial; Could Lead to Other Simple Blood Tests for Cancer Detection

Clinical Evaluation of Cancer Signal Origin Prediction and Diagnostic Resolution Following Multi-cancer Early Detection Testing

Researchers Find AI Improves Breast Cancer Detection by 20%

Initial analyses also shows AI screening lowers associated radiologist image reading workload by half

Both radiologists and pathologists analyze images to make cancer diagnoses, although one works with radiological images and the other works with tissue biopsies as the source of information. Now, advances in artificial intelligence (AI) for cancer screenings means both radiologists and pathologists may soon be able to detect cancer more accurately and in significantly less time.

Pathologists may find it instructive to learn more about how use of this technology shortened the time for the radiologist to sign out the case without compromising accuracy and quality.

Led by researchers at Lund University in Sweden, the Mammography Screening with Artificial Intelligence (MASAI) trial found that using AI during high-risk breast cancer screenings improved breast cancer detection by 20% without affecting the number of false positives, according to a Lund University news release.

Even better, AI screenings reduced doctors’ workload in interpreting mammography  images by nearly 50%, the news release states. Such an improvement would also be a boon to busy pathology practices were this technology to become available for tissue biopsy screenings as well. 

The researchers published their findings in the journal The Lancet Oncology titled, “Artificial Intelligence-Supported Screen Reading versus Standard Double Reading in the Mammography Screening with Artificial Intelligence Trial (MASAI): a Clinical Safety Analysis of a Randomized, Controlled, Non-Inferiority, Single-Blinded Screening Accuracy Study.“

“The greatest potential of AI right now is that it could allow radiologists to be less burdened by the excessive amount of reading,” said breast radiologist Kristina Lång, MD, PhD, Associate Professor in Diagnostic Radiology at Lund University. Pathologists working with clinical laboratories in cancer diagnosis could benefit from similar AI advancements. (Photo copyright: Lund University.)

Can AI Save Time and Improve Diagnoses?

One motivation for conducting this study is that Sweden, like other nations, has a shortage of radiologists. Given ongoing advances in machine learning and AI, researchers launched the study to assess the accuracy of AI in diagnosing images, as well as its ability to make radiologists more productive.

The MASAI trial was the first to demonstrate the effectiveness of AI-supported screening, the Lund news release noted.

“We found that using AI results in the detection of 20% (41) more cancers compared with standard screening, without affecting false positives. A false positive in screening occurs when a woman is recalled but cleared of suspicion of cancer after workup,” said breast radiologist Kristina Lång, MD, PhD, clinical researcher and associate professor in diagnostic radiology at Lund University, and consultant at Skåne University Hospital, in the news release.  

Not only did the researchers explore the accuracy of AI-supported mammography compared with radiologists’ standard screen reading, they also looked into AI’s effect on radiologists’ screen-reading workload, the Lancet paper states.

Impetus for the research was the shortage of radiologists in Sweden and other countries. A Lancet news release noted that “there is a shortage of breast radiologists in many countries, including a shortfall of around 41 (8%) in the UK in 2020 and about 50 in Sweden, and it takes over a decade to train a radiologist capable of interpreting mammograms.”

That makes it even more challenging for providers to meet European Commission Initiatives on Breast and Colorectal Cancer (ECIBC) recommendations that two radiologists screen a woman’s mammogram, the Lancet news release pointed out.

More Breast Cancer Identified with Lower Radiologist Workload When Using AI Screening

Here are study findings, according to the Lancet paper:

  • AI-supported screening resulted in 244 cancers of 861 women recalled.
  • Standard screening found 203 screen-detected cancers among 817 women who were recalled.
  • The false positive rate of 1.5% was the same in both groups.
  • 41 (20%) more cancers were detected in the AI-enabled screening group.
  • Screen readings by radiologists in the AI-supported group totaled 46,345, as compared to 83,231 in the standard screening group.
  • Workload dropped by 44% for physicians using screen-reading with AI.

“We need to see whether these promising results hold up under other conditions—with other radiologists or other algorithms,” Lang said in the Lund news release.

“The results from our first analysis show that AI-supported screening is safe since the cancer detection rate did not decline despite a reduction in the screen-reading workload,” she added.

Is AI a Threat to Radiologists?

The use of AI in the Swedish study is an early indication that the technology is advancing in ways that may contribute to increased diagnostic accuracy for radiologists. But could AI replace human radiologists’ readings. Not anytime soon.

“These promising interim safety results should be used to inform new trials and program-based evaluations to address the pronounced radiologist shortage in many countries. But they are not enough on their own to confirm that AI is ready to be implemented in mammography screening,” Lång cautioned. “We still need to understand the implications on patients’ outcomes, especially whether combining radiologists’ expertise with AI can help detect interval cancers that are often missed by traditional screening, as well as the cost-effectiveness of the technology.”

In an Advisory Board daily briefing, breast radiologist Laura Heacock, MD, of the NYU Langone Perlmutter Cancer Center said, “If you spend a day with a radiologist, you’ll see that how an AI looks at screening a mammogram is really just a fraction of how radiologists practice medicine, even in breast imaging.

“These tools work best when paired with highly trained radiologists who make the final call on your mammogram. Think of it as a tool like a stethoscope for a cardiologist,” she added.

Whether a simple tool or an industry-changing breakthrough, pathology groups and clinical laboratories that work with oncologists can safely assume that AI advances will lead to more cancer research and diagnostic tools that enable earlier and more accurate diagnoses from tissue biopsies and better guidance on therapies for patients.   

—Donna Marie Pocius

Related Information:

How AI Improved Breast Cancer Detection by 20%

Artificial Intelligence-Supported Screen Reading versus Standard Double Reading in the Mammography Screening with Artificial Intelligence Trial (MASAI): a Clinical Safety Analysis of a Randomized, Controlled, Non-Inferiority, Single-Blinded Screening Accuracy Study

AI Can Detect Breast Cancer as Well as Radiologists, Study Finds

AI-Supported Mammography Screening is Found to be Safe

European Breast Cancer Guidelines

AI Use in Breast Cancer Screening as Good as Two Radiologists, Study Finds

Study Finds Smartphones Can Be as Accurate as Pulse Oximeters at Reading Blood-Oxygen Saturation

Technology could enable patients to monitor their own oxygen levels and transmit that data to healthcare providers, including clinical laboratories

Clinical laboratories may soon have a new data point to add to their laboratory information system (LIS) for doctors to review. Researchers have determined that smartphones can read blood-oxygen levels as accurately as purpose-built pulse oximeters.

Conducted by researchers at the University of Washington (UW) and University of California San Diego (UC San Diego), the proof-of-concept study found that an unmodified smartphone camera and flash along with an app is “capable of detecting blood oxygen saturation levels down to 70%. This is the lowest value that pulse oximeters should be able to measure, as recommended by the US Food and Drug Administration,” according to Digital Health News.

This could mean that patients at risk of hypoxemia, or who are suffering a respiratory illness such as COVID-19, could eventually add accurate blood-oxygen saturation (SpO2) readings to their lab test results at any time and from any location.

The researchers published their findings in the journal NPJ Digital Medicine titled, “Smartphone Camera Oximetry in an Induced Hypoxemia Study.”

“In an ideal world, this information could be seamlessly transmitted to a doctor’s office. This would be really beneficial for telemedicine appointments or for triage nurses to be able to quickly determine whether patients need to go to the emergency department or if they can continue to rest at home and make an appointment with their primary care provider later,” Matthew Thompson, DPhil, Professor of Global Health and Family Medicine at University of Washington, told Digital Health News. Clinical laboratories may soon have a new data point for their laboratory information systems. (Photo copyright. University of Washington.)

UW/UC San Diego Study Details

The researchers studied three men and three women, ages 20-34. All were Caucasian except for one African American, Digital Health News reported. To conduct the study, a standard pulse oximeter was placed on a finger and, on the same hand, another of the participant’s fingers was placed over a smartphone camera.

“We performed the first clinical development validation on a smartphone camera-based SpO2 sensing system using a varied fraction of inspired oxygen (FiO2) protocol, creating a clinically relevant validation dataset for solely smartphone-based contact PPG [photoplethysmography] methods on a wider range of SpO2 values (70–100%) than prior studies (85–100%). We built a deep learning model using this data to demonstrate an overall MAE [Mean Absolute Error] = 5.00% SpO2 while identifying positive cases of low SpO2 < 90% with 81% sensitivity and 79% specificity,” the researchers wrote in NPJ Digital Medicine.

When the smartphone camera’s flash passes light through the finger, “a deep-learning algorithm deciphers the blood oxygen levels.” Participants were also breathing in “a controlled mixture of oxygen and nitrogen to slowly reduce oxygen levels,” Digital Health News reported.

“The camera is recording a video: Every time your heart beats, fresh blood flows through the part illuminated by the flash,” Edward Wang, PhD, Assistant Professor of Electrical and Computer Engineering at UC San Diego and senior author of the project, told Digital Health News. Wang started this project as a UW doctoral student studying electrical and computer engineering and now directs the UC San Diego DigiHealth Lab.

“The camera records how much that blood absorbs the light from the flash in each of the three color channels it measures: red, green, and blue. Then we can feed those intensity measurements into our deep-learning model,” he added.

The deep learning algorithm “pulled out the blood oxygen levels. The remainder of the data was used to validate the method and then test it to see how well it performed on new subjects,” Digital Health News reported.

“Smartphone light can get scattered by all these other components in your finger, which means there’s a lot of noise in the data that we’re looking at,” Varun Viswanath, co-lead author in the study, told Digital Health News. Viswanath is a UW alumnus who is now a doctoral student being advised by Wang at UC San Diego.

“Deep learning is a really helpful technique here because it can see these really complex and nuanced features and helps you find patterns that you wouldn’t otherwise be able to see,” he added.

Each round of testing took approximately 15 minutes. In total the researchers gathered more than 10,000 blood oxygen readings. Levels ranged from 61% to 100%.

“The smartphone correctly predicted whether the subject had low blood oxygen levels 80% of the time,” Digital Health News reported.

Smartphones Accurately Collecting Data

The UW/UC San Diego study is the first to show such precise results using a smartphone.

“Other smartphone apps that do this were developed by asking people to hold their breath. But people get very uncomfortable and have to breathe after a minute or so, and that’s before their blood-oxygen levels have gone down far enough to represent the full range of clinically relevant data,” said Jason Hoffman, a PhD student researcher at UW’s UbiComp Lab and co-lead author of the study.

The ability to track a full 15 minutes of data is a prime example of improvement. “Our data shows that smartphones could work well right in the critical threshold range,” Hoffman added.

“Smartphone-based SpO2 monitors, especially those that rely only on built-in hardware with no modifications, present an opportunity to detect and monitor respiratory conditions in contexts where pulse oximeters are less available,” the researchers wrote.

“This way you could have multiple measurements with your own device at either no cost or low cost,” Matthew Thompson, DPhil, Professor of Global Health and Family Medicine at University of Washington, told Digital Health News. Thompson is a professor of both family medicine and global health and an adjunct professor of pediatrics at the UW School of Medicine.

What Comes Next

The UW/UC San Diego research team plans to continue its research and gather more diversity among subjects.

“It’s so important to do a study like this,” Wang said. “Traditional medical devices go through rigorous testing. But computer science research is still just starting to dig its teeth into using machine learning for biomedical device development and we’re all still learning. By forcing ourselves to be rigorous, we’re forcing ourselves to learn how to do things right.”

Though no current clinical laboratory application is pending, smartphone use to capture biometrics for testing is increasing. Soon, labs may need a way to input all that data into their laboratory information systems. It’s something to consider.

—Kristin Althea O’Connor

Related Information:

A Smartphone’s Camera and Flash could Help People Measure Blood Oxygen Levels at Home

Smartphones Can Measure Blood Oxygen Levels at Home

Smartphone’s Camera, Flash, Can Measure Blood Oxygen Up to 70% at Home

Smartphone Camera Oximetry in an Induced Hypoxemia Study

Australian Medical Laboratory Worker Who Allegedly Swapped Tissue Samples to Damage Co-Worker’s Reputation Now ‘Banned for Life’ from Providing Health Services

Australian government rules lab employee’s rogue actions jeopardized patient care

In an example of “if something can go wrong in the lab, it will,” a senior histology laboratory worker at Royal North Shore Hospital in Sydney, Australia, has been banned for life from providing health services for allegedly swapping patient tissue samples in an attempt to harm a lab co-worker, according to The Sydney Morning Herald.

Dianne Reader, 61, was a “a senior technical officer at the Anatomical Pathology Laboratory with more than 40 years’ experience,” the Herald noted, adding that Reader “had swapped 20 patient tissue samples, leading to the misdiagnosis of at least one patient.”

Her motivation, the Herald reported, was to “target and discredit her colleague.”

“Ms. Reader repeatedly engaged in conduct that demonstrated a flagrant disregard for patient health and safety” that may have “serious adverse consequences for the patients involved,” Tony Kofkin at Australia’s Health Care Complaints Commission told The Sydney Morning Herald. This is a lesson that clinical laboratory managers can never be too diligent because something unexpected can happen at any moment—and these events have the potential to cause serious patient harm. (Photo copyright: LinkedIn.)  

Lab Staff Suspicions Raised

The sample mixups began in 2020, when the targeted employee (employee A) was working specimen “cut-up” duty. After two incidents of sample mixups being found in her work, she was removed from the duty for three weeks. The Herald reported that the employee told a co-worker she believed she was being “framed.” When she returned to cut-up duty, she took photographs of her work as a precautionary measure.

The employee’s photos served as evidence when that day’s work again showed errors, now the third incident of sample mixups. Upon further research, a total of four occasions of swapping samples were discovered between March and June of 2020.

Laboratory records showed that Reader was responsible for unpacking the tissue processor on each of those occasions, the Herald noted.

Lab workers noted a strained working relationship between Reader and the targeted employee. “One co-worker, a hospital scientist, told the [Health Care Complaints Commission] the working relationship between Reader and ‘Employee A’ could be ‘frosty,’” the Herald reported.

Lab staff apparently grew suspicious when a co-worker discovered that Reader “was only looking up gall bladder and appendices samples on the mornings Employee A had been ‘cutting up’ (dissecting and describing samples before placing them into cassettes for processing).” Lab staff also confirmed to the Health Care Complaints Commission that Reader had improperly accessed 43 patient records, adding that “there was no reason for her to have accessed the records when she did,” The Sydney Morning Herald reported.

Reader, according to the Herald, “denied she had ever interchanged specimens or improperly accessed patient files in two recorded interviews in July 2020, and maintains her innocence.”

Nevertheless, Tony Kofkin, the Commission’s complaint operations Executive Director, found that Reader “posed a risk to the health and safety of the public because she was prepared to risk patient safety in order to discredit her colleague.

“Ms. Reader repeatedly engaged in conduct that demonstrated a flagrant disregard for patient health and safety,” he wrote in the Commission’s findings, adding that Reader “had shown no remorse or insight into her conduct ‘despite the overwhelming evidence’ and as such posed a permanent risk to the health and safety of the public,” the Herald reported.

The Health Care Complaints Commission determined that Reader’s actions were “motivated by a desire to target and discredit her colleague.” The Commission’s decision prevents Reader from forever providing healthcare services, including medical, hospital, pharmaceutical, forensic pathology, or health education services, according to the Herald.

Who Was Harmed by the Swapped Samples?

Reader’s alleged actions had significant consequences. One patient’s swapped sample nearly led her to having a hysteroscopy for a glandular polyp, when in fact she was suffering with endometrial hyperplasia. Thankfully, the histology laboratory staff discovered the mistake and quickly contacted the patient’s doctor to ensure the proper surgery was performed, the Herald noted.

Things could have gone much worse for that patient and for others. Clinical laboratory managers should look upon this as a cautionary tale and consider how to ensure similar—and very rare—occurrences do not happen in their own laboratories.

—Kristin Althea O’Connor

Related Information:

Sydney Laboratory Worker Swapped Patient Samples to ‘Target and Discredit’ Co-Worker

Health Care Complaints Commission Decision