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Clinical Laboratories and Pathology Groups

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Separate Reports Shed Light on Why CDC SARS-CoV-2 Test Kits Failed During Start of COVID-19 Pandemic

HHS Office of Inspector General was the latest to examine the quality control problems that led to distribution of inaccurate test to clinical laboratories nationwide

Failure on the part of the Centers for Disease Control and Prevention (CDC) to produce accurate, dependable SARS-CoV-2 clinical laboratory test kits at the start of the COVID-19 pandemic continues to draw scrutiny and criticism of the actions taken by the federal agency.

In the early weeks of the COVID-19 pandemic, the CDC distributed faulty SARS-CoV-2 test kits to public health laboratories (PHLs), delaying the response to the outbreak at a critical juncture. That failure was widely publicized at the time. But within the past year, two reports have provided a more detailed look at the shortcomings that led to the snafu.

The most recent assessment came in an October 2023 report from the US Department of Health and Human Services Office of Inspector General (OIG), following an audit of the public health agency. The report was titled, “CDC’s Internal Control Weaknesses Led to Its Initial COVID-19 Test Kit Failure, but CDC Ultimately Created a Working Test Kit.”

“We identified weaknesses in CDC’s COVID-19 test kit development processes and the agencywide laboratory quality processes that may have contributed to the failure of the initial COVID-19 test kits,” the OIG stated in its report.

Prior to the outbreak, the agency had internal documents that were supposed to provide guidance for how to respond to public health emergencies. However, “these documents do not address the development of a test kit,” the OIG stated.

Jill Taylor, PhD

“If the CDC can’t change, [its] importance in health in the nation will decline,” said microbiologist Jill Taylor, PhD (above), Senior Adviser for the Association of Public Health Laboratories in Washington, DC. “The coordination of public health emergency responses in the nation will be worse off.” Clinical laboratories that were blocked from developing their own SARS-CoV-2 test during the pandemic would certainly agree. (Photo copyright: Columbia University.)

Problems at the CDC’s RVD Lab

Much of the OIG’s report focused on the CDC’s Respiratory Virus Diagnostic (RVD) lab which was part of the CDC’s National Center for Immunization and Respiratory Diseases (NCIRD). The RVD lab had primary responsibility for developing, producing, and distributing the test kits. Because it was focused on research, it “was not set up to develop and manufacture test kits and therefore had no policies and procedures for developing and manufacturing test kits,” the report stated.

The RVD lab also lacked the staff and funding to handle test kit development in a public health emergency, the report stated. As a result, “the lead scientist not only managed but also participated in all test kit development processes,” the report stated. “In addition, when the initial test kit failed at some PHLs, the lead scientist was also responsible for troubleshooting and correcting the problem.”

To verify the test kit, the RVD lab needed samples of viral material from the agency’s Biotechnology Core Facility Branch (BCFB) CORE Lab, which also manufactured reagents for the kit.

“RVD Lab, which was under pressure to quickly create a test kit for the emerging health threat, insisted that CORE Lab deviate from its usual practices of segregating these two activities and fulfill orders for both reagents and viral material,” the report stated.

This increased the risk of contamination, the report said. An analysis by CDC scientists “did not determine whether a process error or contamination was at fault for the test kit failure; however, based on our interviews with CDC personnel, contamination could not be ruled out,” the report stated.

The report also cited the CDC’s lack of standardized systems for quality control and management of laboratory documents. Labs involved in test kit development used two different incompatible systems for tracking and managing documents, “resulting in staff being unable to distinguish between draft, obsolete, and current versions of laboratory procedures and forms.”

Outside Experts Weigh In

The OIG report followed an earlier review by the CDC’s Laboratory Workgroup (LW), which consists of 12 outside experts, including academics, clinical laboratory directors, state public health laboratory directors, and a science advisor from the Association of Public Health Laboratories. Members were appointed by the CDC Advisory Committee to the Director.

This group cited four major issues:

  • Lack of adequate planning: For the “rapid development, validation, manufacture, and distribution of a test for a novel pathogen.”
  • Ineffective governance: Three labs—the RVD Lab, CORE Lab, and Reagent and Diagnostic Services Branch—were involved in test kit development and manufacturing. “At no point, however, were these three laboratories brought together under unified leadership to develop the SARS-CoV-2 test,” the report stated.
  • Poor quality control and oversight: “Essentially, at the start of the pandemic, infectious disease clinical laboratories at CDC were not held to the same quality and regulatory standards that equivalent high-complexity public health, clinical and commercial reference laboratories in the United States are held,” the report stated.
  • Poor test design processes: The report noted that the test kit had three probes designed to bind to different parts of the SARS-CoV-2 nucleocapsid gene. The first two—N1 (topology) and N2 (intracellular localization)—were designed to match SARS-CoV-2 specifically, whereas the third—N3 (functions of the protein)—was designed to match all Sarbecoviruses, the family that includes SARS-CoV-2 as well as the coronavirus responsible for the 2002-2004 SARS outbreak.

The N1 probe was found to be contaminated, the group’s report stated, while the N3 probe was poorly designed. The report questioned the decision to include the N3 probe, which was not included in European tests.

Also lacking were “clearly defined pass/fail threshold criteria for test validation,” the report stated.

Advice to the CDC

Both reports made recommendations for changes at the CDC, but the LW’s were more far-reaching. For example, it advised the agency to establish a senior leader position “with major responsibility and authority for laboratories at the agency.” This individual would oversee a new Center that would “focus on clinical laboratory quality, laboratory safety, workforce training, readiness and response, and manufacturing.”

In addition, the CDC should consolidate its clinical diagnostic laboratories, the report advised, and “laboratories that follow a clinical quality management system should have separate technical staff and space from those that do not follow such a system, such as certain research laboratories.”

The report also called for collaboration with “high functioning public health laboratories, hospital and academic laboratories, and commercial reference laboratories.” For example, collaborating on test design and development “should eliminate the risk of a single point of failure for test design and validation,” the LW suggested.

CBS News reported in August that the CDC had already begun implementing some of the group’s suggestions, including agencywide quality standards and better coordination with state labs.

However, “recommendations for the agency to physically separate its clinical laboratories from its research laboratories, or to train researchers to uphold new quality standards, will be heavy lifts because they require continuous funding,” CBS News reported, citing an interview with Jim Pirkle, MD, PhD, Director, Division of Laboratory Sciences, National Center for Environmental Health, at the CDC.

—Stephen Beale

Related Information:

CDC’s Internal Control Weaknesses Led to Its Initial COVID-19 Test Kit Failure, but CDC Ultimately Created a Working Test Kit  

Review of the Shortcomings of CDC’s First COVID-19 Test and Recommendations for the Policies, Practices, and Systems to Mitigate Future Issues      

Collaboration to Improve Emergency Laboratory Response: Open Letter from the Association of Pathology Chairs to the Centers for Disease Control and Prevention    

The CDC Works to Overhaul Lab Operations after COVID Test Flop

In Early Weeks of Flu Season, COVID-19 Patients Show Milder Symptoms as SARS-CoV-2 Continues to Evolve

Doctors report difficulty differentiating COVID-19 from other viral infections, impacting clinical laboratory test orders

Because the SARS-CoV-2 coronavirus is in the same family of viruses that cause the common cold and influenza, virologists expected this virus—which caused the global COVID-19 pandemic—would evolve and mutate into a milder form of infection. Early evidence from this influenza season seems consistent with these expectations in ways that will influence how clinical laboratories offer tests for different respiratory viruses.

While new variants of the SARS-CoV-2 virus continue to appear, indications are that early in this flu season individuals infected with the more recent variants are experiencing milder symptoms when compared to the last few years. Doctors report they find it increasingly difficult to distinguish COVID-19 infections from allergies or the common cold because patients’ symptoms are less severe, according to NBC News.

This, of course, makes it challenging for doctors to know the most appropriate clinical laboratory tests to order to help them make accurate diagnoses.

Erick Eiting, MD

“It isn’t the same typical symptoms that we were seeing before. It’s a lot of congestion, sometimes sneezing, usually a mild sore throat,” Erick Eiting, MD, Vice Chair of Operations for Emergency Medicine at Mount Sinai Hospital in New York City, told NBC News. “Just about everyone who I’ve seen has had really mild symptoms. The only way that we knew that it was COVID was because we happened to be testing them.” Knowing which tests for respiratory viruses that clinical laboratories need to perform may soon be the challenge for doctors. (Photo copyright: Mt. Sinai.)

Milder COVID-19 Symptoms Follow a Pattern

Previous hallmarks of a COVID-19 infection included:

  • Loss of taste,
  • loss of smell,
  • dry cough,
  • fever,
  • sore throat,
  • diarrhea,
  • body aches,
  • headaches.

However, physicians now observe milder symptoms of the infection that follow a distinct pattern and which are mostly concentrated in the upper respiratory tract

Grace McComsey, MD, Vice President of Research and Associate Chief Scientific Officer at University Hospitals Health System (UH) in Cleveland, Ohio, told NBC News that some patients have described their throat pain as “a burning sensation like they never had, even with Strep in the past.”

“Then, as soon as the congestion happens, it seems like the throat gets better,” she added.

In addition to the congestion, some patients are experiencing:

  • headache,
  • fever,
  • chills,
  • fatigue,
  • muscle aches,
  • post-nasal drip. 

McComsey noted that fatigue and muscle aches usually only last a couple of days, but that the congestion can sometimes last a few weeks. She also estimated that only around 10-20% of her newest COVID patients are losing their sense of smell or taste, whereas early in the pandemic that number was closer to 60-70% of her patients. 

Doctors also noted that fewer patients are requiring hospitalization and that many recover without the use of antivirals or other treatments.

“Especially since July, when this recent mini-surge started, younger people that have upper respiratory symptoms—cough, runny nose, sore throat, fever and chills—99% of the time they go home with supportive care,” said Michael Daignault, MD, an emergency physician at Providence Saint Joseph Medical Center in Burbank, California.

Milder SARS-CoV-2 Variants Should Still be Taken Seriously

Doctors have varying opinions regarding why the current COVID-19 variants are milder. Some believe the recent variants simply aren’t as good at infecting the lungs as previous variants.

“Overall, the severity of COVID-19 is much lower than it was a year ago and two years ago,” Dan Barouch, MD, PhD, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, told NBC News. “That’s not because the variants are less robust. It’s because the immune responses are higher.”

McComsey added that she doesn’t think mild cases should be ignored as she is still seeing new cases of long COVID with rapid heart rate and exercise intolerance being among the most common lingering symptoms. Re-infections also add to the risks associated with long COVID.

“What we’re seeing in long COVID clinics is not just the older strains that continue to be symptomatic and not getting better—we’re adding to that number with the new strain as well,” McComsey said. “That’s why I’m not taking this new wave any less seriously.”

Clinical Laboratory COVID-19 Testing May Decrease

According to Andrew Read, PhD, Interim Senior Vice President for Research and Evan Pugh University Professor of Biology and Entomology at Pennsylvania State University, there is nothing unexpected or startling about the coronavirus acquiring new mutations.

“When a mutation confers an interesting new trick that’s got an advantage, it’s going to be popping up in many different places,” Read told the New York Times. “Everything we see is just consistent with how you imagine virus evolution proceeding in a situation where a new virus has jumped into a novel host population.”

Data from the Centers for Disease Control and Prevention’s COVID-19 Data Tracker—which reports weekly hospitalizations, deaths, emergency department (ED) visits, and COVID-19 test positivity results—shows infection trends fluctuating, but overall, they are decreasing.

  • For the week of October 21, 2023, there were 16,186 hospitalizations due to COVID-19 compared to the highest week recorded (January 15, 2022) with 150,674 hospitalizations nationwide.
  • The highest number of deaths reported in a single week were 25,974 for the week of January 8, 2021, while 637 patients perished from COVID-19 during the week of October 21, 2023.
  • In January of 2021, COVID accounted for 13.8% of all ED visits and in October 2023, COVID-19 was responsible for 1.3% of ED visits. 

“What I think we’re seeing is the virus continuing to evolve, and then leading to waves of infection, hopefully mostly mild in severity,” Barouch told The New York Times.

As severity of COVID-19 infections continues to fall, so, presumably, will demand for COVID-19 testing which has been a source of revenue for clinical laboratories for several years.

—JP Schlingman

Related Information:

Sore Throat, Then Congestion: Common COVID Symptoms Follow a Pattern Now, Doctors Say

COVID Continues to Rise, but Experts Remain Optimistic

What Is the Order of COVID Symptoms This Fall?

COVID Symptoms Now Follow a Distinct Pattern, Doctors Report

How are COVID-19 Symptoms Changing?

What Are the Mild Symptoms of COVID-19, and When Should You See a Doctor?

Doctors Admit They Can’t Tell COVID Apart from Allergies or the Common Cold Anymore—Highlighting How Mild Virus has Become

The Evolution of SARS-CoV-2

UCSF Researchers Identify Genetic Mutation That Promotes an Asymptomatic Response in Humans to COVID-19 Infection

University of Pennsylvania Researchers Use Cellulose to Produce Accurate Rapid COVID-19 Test Results Faster and Cheaper than Traditional PCR Tests

Researchers are working to create accurate rapid COVID-19 tests with lower costs and less waste than existing rapid clinical laboratory tests

University of Pennsylvania (UPenn) researchers have developed a biodegradable rapid COVID-19 test that raises the bar on traditional polymerase chain reaction (PCR) tests, which throughout the COVID-19 pandemic have been the gold standard for SARS-CoV-2 diagnostic testing.

Many clinical laboratory professionals are aware of the significant amount of waste going into landfills from spent COVID-19 rapid PCR tests that use biosensors to produce results. These biosensor systems “use printed circuit boards, or PCBs, the same materials used in computers. PCBs are difficult to recycle and slow to biodegrade, using large amounts of metal, plastic, and non-eco-friendly materials,” according to a Penn Engineering Today blog post.

UPenn’s new test does not use PCBs. Instead, its biosensor uses “bacterial cellulose (BC), an organic compound synthesized from several strains of bacteria,” the blog post noted.

“This new BC test is non-toxic, naturally biodegradable and both inexpensive and scalable to mass production, currently costing less than $4.00 per test to produce. Its cellulose fibers do not require the chemicals used to manufacture paper, and the test is almost entirely biodegradable,” the blog post continued.

The Penn engineers published their findings in the journal Cell Reports Physical Science titled, “A Bacterial Cellulose-Based and Low-Cost Electrochemical Biosensor for Ultrasensitive Detection of SARS-CoV-2.”

Cesar de la Fuente, PhD

“There is a need for biodegradable diagnostic testing,” said Cesar de la Fuente, PhD (above), Presidential Assistant Professor in the Psychiatry Department at the University of Pennsylvania’s Perelman School of Medicine. “We will be continuing to perfect this technology, which could hopefully help many people in the future, while also looking to expand it to other emerging pathogens in anticipation of future pandemics.” Clinical laboratories engaged in SARS-CoV-2 testing during the COVID-19 pandemic can attest to the massive amounts of waste generated by traditional PCR testing. (Photo copyright: University of Pennsylvania.)

Evolution of Improvement for SARS-CoV-2 Diagnostic Assays

Cesar de la Fuente, PhD, is Presidential Assistant Professor in the Psychiatry Department at the Perelman School of Medicine. His lab has been hard at work since the start of the pandemic to improve COVID-19 testing. The recent study was a collaboration between University of Pennsylvania’s de la Fuente Lab and William Reis de Araujo, Professor in Analytical Chemistry at the State University of Campinas (UNICAMP) in São Paulo, Brazil.

De Araujo leads the Portable Chemical Sensors Lab and has been pairing his electrochemistry expertise with de la Fuente’s lab for years, Penn Engineering Today noted.

The team wanted to combine the speed and cost-effectiveness of previous rapid tests with an eco-friendly biodegradable substrate material.

Bacterial cellulose (BC) was a great choice because it “naturally serves as a factory for the production of cellulose, a paper-like substance which can be used as the basis for biosensors,” Penn Engineering Today reported.

Additionally, BC has an excellent track record for a variety of uses, such as regenerative medicine, wound care, and point-of-care (POC) diagnostics, the blog post noted. UPenn’s test offers speed and accuracy without needing costly equipment making it desirable for clinical laboratories preparing to fight the next pandemic.

The test has shown to be capable of “correctly identifying multiple variants in under 10 minutes. This means that the tests won’t require ‘recalibration’ to accurately test for new variants,” Penn Engineering Today added.

Innovation Born from Inspiration

Though rapid tests are essential to help curb the spread of COVID-19, the negatives that come with these tests didn’t sit well with the UPenn team. This spurred them to strive for improvements.

PCR tests “are hampered by waste [metal, plastic, and the aforementioned PCBs]. They require significant time [results can take up to a day or more] as well as specialized equipment and labor, all of which increase costs,” Penn Engineering Today noted.

Additionally, “Sophistication of PCR tests makes them harder to tweak and therefore slower to respond to new variants,” the blog post concluded.

“There’s a tension between these two worlds of innovation and conservation,” de la Fuente told Penn Engineering Today. “When we create new technology, we have a responsibility to think through the consequences for the planet and to find ways to mitigate the environmental impact.” 

Need for Biodegradable Diagnostic Tests

“COVID-19 has led to over 6.8 million deaths worldwide and continues to affect millions of people, primarily in low-income countries and communities with low vaccination coverage,” the Cell Reports Physical Science paper noted.

“There is a need for biodegradable diagnostic testing,” de la Fuentes told Penn Engineering Today. “We will be continuing to perfect this technology, which could hopefully help many people in the future, while also looking to expand it to other emerging pathogens in anticipation of future pandemics.”

While UPenn’s test will require clinical trials and FDA approval before it can become available to clinical laboratories and for point-of-care testing, it promises a bright, eco-friendly future for rapid viral testing.

—Kristin Althea O’Connor

Related Information:

Penn Engineers Create Low-Cost, Eco-Friendly COVID Test

A Bacterial Cellulose-Based and Low-Cost Electrochemical Biosensor for Ultrasensitive Detection of SARS-CoV-2

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

Penn Researchers Develop Faster, Biodegradable COVID-19 Tests

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

Millions of COVID-19 At-Home Tests Set to Flood Market as HHS Asks 12 Test Manufacturers to Produce 200 Million Tests

Free at home clinical-laboratory testing for COVID-19 has been provided in the past, but this time the federal government wants to manufacture as many tests as possible in the US

Pathologists and clinical laboratory managers may be interested to learn that the US market is about to be flooded with millions of at-home COVID-19 rapid tests. The federal government has contracted with 12 US-based test manufacturers to produce 200 million at-home self-tests aimed at detecting “currently circulating COVID-19 variants” through the end of this year, according to a US Department of Health and Human Services (HHS) news release.

Through the Administration for Strategic Preparedness and Response (ASPR), HHS is investing $600 million to fund the self-tests, which are available for delivery through a reopening of the COVID.Gov/Test website.

Federal officials want to head off “supply chain issues” that developed in the past with reliance on tests made overseas, and to address a possible COVID-19 surge during the fall and winter, the Associated Press (AP) reported.

In fact, 500 million tests have already been distributed through US government channels to long-term care facilities, schools, and low-income senior housing.

Dawn O’Connell, JD

“Manufacturing COVID-19 tests in the United States strengthens our preparedness for the upcoming fall and winter seasons, reduces our reliance on other countries, and provides good jobs to hardworking Americans,” said Assistant Secretary for Preparedness and Response Dawn O’Connell, JD (above), in an HHS news release. “ASPR’s investments in these domestic manufacturers will increase availability of tests in the future.” With the federal government preparing for what it expects to be a surge in demand for COVID-19 testing, clinical laboratories may want to track the CDC’s weekly reports on the number of positive COVID-19 cases as this year’s influenza season progresses. (Photo copyright: Administration for Strategic Preparedness and Response.)

In Vitro Diagnostics Test Makers Get Government Gigs

This is not the first time federal officials sent out free COVID-19 tests to consumers. According to the AP, more than 755 million tests went out to US households in previous efforts to fight the spread of infections. But unlike those tests, these tests will be manufactured entirely within the US.

The government’s latest wave of free tests is meant to “complement ASPR’s ongoing distribution of free COVID-19 tests to long-term care facilities, low-income senior housing, uninsured individuals, and underserved communities, with 500 million tests provided to date through these channels,” the HHS news release noted.  

Both large and lesser-known in vitro diagnostics (IVD) manufacturers were selected by the federal government to receive funding. They include:

HHS advises people to take the test at the first sign of symptoms (fever, sore throat, runny nose, others), after coming into contact someone who has COVID-19, or prior to gathering with a group, as a preventative to spread of the coronavirus.

Tracking New BA.2.86 COVID Variant

Currently, the federal Centers for Disease Control and Prevention (CDC) is tracking BA.2.86 (aka, Pirola), a new SARS-CoV-2 variant.

According to CDC’s latest Respiratory Viruses Update:

  • Reporting laboratories say existing antibodies work against the BA.2.86 variant.
  • The variant does not appear to be linked in the US with increasing infections or hospitalizations.
  • It is “unclear how easily BA.2.86 spreads” relative to other variants.
  • BA.2.86 has been detected in nine states: Colorado, Delaware, Michigan, Ohio, Pennsylvania, Virginia, Washington, and in wastewater in New York and Ohio, as well as in other countries. 

For week ending Sept. 23, the CDC reported the following statistics compared to the prior week:

  • 19,079 COVID-19 hospitalizations, down 3.1%.
  • Total hospitalizations: 6.3 million.
  • 2.7% of total deaths were due to COVID-19, up 8%.
  • COVID-19 test positivity rate was 11.6%, down 1.1%.
  • 1.8% of emergency department visits were diagnosed with COVID-19, down 11.7%.

According to Verywell Health, BA.2.86 carries more than 30 mutations.  

“Even with a lot of mutations, there are a lot of spots in the virus that can be recognized by our immune system, and there are many shared mutations as well. There will be some protection from new vaccine booster as well as prior infections,” Rajendram Rajnarayanan, PhD, Assistant Dean of Research and Associate Professor, Basic Sciences, Arkansas State University, told Verywell Health.

During an online media briefing conducted by the World Health Organization (WHO), Maria Van Kerkhove, PhD, COVID-19 Technical Lead at WHO, said that the variant could be classified by WHO as a “variant of concern” in the event of widespread circulation. 

COVID-19, an Endemic Disease?

It’s worth noting that the common cold, influenza, SARS, and SARS-CoV-2 are all in the coronavirus family, and thus closely related with similar symptoms. It would not be a surprise that SARS-CoV-2 joins those other viruses as an endemic virus with a similar yearly cycle of infection rates.

If that happens, and no surge in infections appears that would motivate orders for the new COVID-19 at-home tests, the government may find itself with a lot of unused tests at the end of the year. The US Food and Drug Administration (FDA) is aware of this possibility and provides a website where people can check to see if their test has an extended expiration date.

Plus, folks who are tired of the pandemic may not respond at all to the government’s insistence to prepare for possible surges in infection rates.

“Whether or not people are done with it, we know the virus is there, we know that it’s circulating. We know, if past is prologue, it’ll circulate to a higher degree and spread, and cases will go up in the fall and winter seasons,” said Assistant Secretary for Preparedness and Response Dawn O’Connell, JD, in the HHS new release. “Anticipating that that would be true again, or something similar, we want to make sure the American people have these tools.”

Clinical laboratories may want to prepare as well. Many people are not comfortable with at-home self-testing and prefer to have their local medical labs perform the tests.

—Donna Marie Pocius

Related Information:

Biden-Harris Administration Awards $600 Million to Bolster US Manufacturing of COVID-19 Tests and Announces the Re-Opening of COVIDTests.gov

Biden Administration Announces $600 Million to Produce COVID-19 Tests and Will Reopen Website to Order Them

Free COVID Testing Will Fade with US Health Emergency in May

CDC’s COVID-19 Variant Update

CDC’s COVID-19 Data Tracker

Why B.2.86 Stands Out from Other COVID-19 Variants

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 Amazon.com, Alibris.com, 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

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