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Clinical Laboratories and Pathology Groups

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Understanding Gen Z’s Approach to Healthcare Helps Clinical Laboratories Learn How to Better Meet Their Needs

Healthcare providers of all types will benefit from acknowledging Gen Z’s preference for digital interactions, self-testing, and over-the-counter medications

Each generation has its own unique connection to how it manages its health, and the latest studies into the healthcare habits of Generation Z (aka, Gen Z or Zoomers) are providing valuable insight that savvy clinical laboratory managers and pathologists—in fact all healthcare providers—can use to better serve their Gen Z patients.

According to McKinsey and Company, Gen Z’s “identity has been shaped by the digital age, climate anxiety, a shifting financial landscape, and COVID-19.” And Pew Research states that Zoomers “are also digital natives who have little or no memory of the world as it existed before smartphones.”

As the largest demographic, “Gen Z stands 2.6 billion members strong. … Globally, they hold purchasing power of more than $500 billion and mobile buying power of $143 billion,” wrote Stacy Rapacon, Managing Editor at Senior Executive Media, in an article she penned for HP’s The Garage.

Meeting Gen Zers’ healthcare needs on their terms would seem to be a judicious choice.

Bernhard Schroeder

“Gen-Z’s buying power may exceed $3 trillion,” wrote Bernhard Schroeder (above), a clinical lecturer on integrated/online marketing at San Diego State University, in Forbes. “Their spending ability exceeds the gross domestic product of all but about 25 of the world’s countries.” Thus, it behooves healthcare leaders, including clinical laboratory managers and pathologists, to consider how best to approach treating Gen Z patients. (Photo copyright: San Diego State University.)

Gen Z Leads in Digital Healthcare Use, Self-testing, OTC Drugs

“Gen Z engages in every type of digital healthcare activity more than other generations,” a recent study by PYMNTS noted. A total of 2,735 consumers were surveyed, and though all reported using digital healthcare to some degree, Gen Z stood out.

Patient portal access was the highest digital method accessed by Zoomers (62%), followed by telemedicine appointment usage (55%), the PYMNTS report found.

Knowing the direction Gen Z is trending may lead clinical laboratory leaders to expect self-testing to be on the rise, and that hunch would be correct. “There are two converging trends; the rise of women’s health technology and increased use of at-home sample collection for diagnosis tests,” Clinical Lab Products reported.

“Ongoing innovation in these areas could significantly improve the accessibility of women’s health testing. It will also have repercussions for labs, potentially changing the way samples are received and processed, and the way results are distributed. The quantity and quality of samples may be impacted, too. It’s important for labs to be aware of likely developments so they can prepare, and potentially collaborate with the health technology companies driving change,” CLP noted.

Another area feeling the impact of Gen Z’s healthcare spending is the over-the-counter (OTC) drug market.

“Since the pandemic began, more Americans are paying closer attention to their symptoms and looking for easily accessible information about over-the-counter medications, especially for allergies, coughs, and headaches,” said Kim Castro, Editor and Chief Content Officer for US News and World Report, in a press release.

Zoomers Want Healthcare on Their Own Terms

Gen Z grew up with the internet, Amazon, Netflix, Google, and social media since birth.

“The ‘norm’ they experienced as children was a world that operated at speed, scale, and scope. They developed an early facility with powerful digital tools that allowed them to be self-reliant as well as collaborative,” anthropologist Roberta Katz, PhD, a senior research scholar at Stanford’s Center for Advanced Study in the Behavioral Sciences (CASBS) told Stanford News.

As digital natives, Gen Z can be more science and data driven and yet still expect to find health advice on YouTube or TikTok. According to an article published by Harvard Pilgrim Healthcare, “Gen Z is the first generation to grow up surrounded by digital devices, and they expect their health benefits to be digital, too. From choosing a benefits package to finding a provider, Gen Z wants to take care of their health on their own terms. And that may just include video chatting with a doctor from the back of an Uber.”

In its 2022 US Digital Health Survey, research firm Insider Intelligence found that “Half of Gen Z adults turn to social media platforms for health-related purposes, either all the time or often.”

“Gen-Z will make up 31% of the world’s population by 2021 and they have deeply formed perceptions and beliefs … This has led to an amazing change in the way Gen-Z is disrupting several industries simultaneously,” wrote Bernhard Schroeder (above), a clinical lecturer on integrated/online marketing at San Diego State University, in Forbes.

What Can Clinical Laboratories Learn from These Findings

Gen Z seeks accuracy and trustworthy information. “Gen-Zers’ natural penchant for skepticism and frugality—coupled with low levels of confidence in the US healthcare system—makes them less likely to trust providers, more likely to research prices before seeking care, and more apt to worry that their health insurance won’t cover their treatment,” Insider Intelligence noted.

According to Contract Pharma, “Gen Z is concerned with holistic health and self-care, rather than a one size fits all pharmaceutical approach. They share a hesitancy for traditional healthcare models but with very interesting differences. By understanding these differences, the consumer healthcare industry can focus on agile and distinctive brands to harness Gen Z’s tremendous purchasing power.”

Savvy clinical laboratory leaders can better serve their Gen-Z client physicians and patients by better understanding why Zoomers are more inclined to order their own lab tests (without a physician), collect their own specimens to send into labs, and/or collect their own specimens to do home testing (think COVID-19 self-test kits). Zoomers may need an entirely new business model from their healthcare providers, including clinical laboratories.

Kristin Althea O’Connor

Related Information:

What is Gen Z?

On the Cusp of Adulthood and Facing an Uncertain Future: What We Know about Gen Z So Far

How Gen Z is Redefining Their World through Technology

Gen Z Is ‘Generation Digital Health’ as 62% Use Digital Patient Portals

What Self-Sampling for Women’s Health Testing Means for Labs

US News Top Recommended Over-the-Counter Health Products

Gen Z Are Not ‘Coddled.’ They Are Highly Collaborative, Self-Reliant and Pragmatic, According to New Stanford-Affiliated Research

Who is Gen Z and How Are They Shaping the Future of Health Benefits?

Generation Z: Transforming Consumer Healthcare

Gen Z’s Take on Healthcare

US Generation Z Healthcare Behaviors

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

Smart Pacifier That Monitors Electrolyte Levels in Saliva Could Prove to Be Beneficial for Vital Care of Infants in Newborn Intensive Care Units

Tiny sensors with Bluetooth technology that measure useful biomarkers may eliminate need for invasive blood draws used for clinical laboratory tests

What if a baby’s pacifier could be used to measure electrolyte levels in newborns? An international research team has developed just such a device, and it has the potential to reduce invasive blood collections required to provide specimens for clinical laboratory testing of critical biomarkers. At the same time, this device may allow continuous monitoring of electrolyte levels with wireless alerts to caregivers.

Developed at Washington State University (WSU) Vancouver with researchers from the United States and South Korea, the wireless bioelectronic pacifier monitors electrolyte levels in newborn intensive care unit (NICU) babies and sends the collected data to caregivers and hospital information systems in real time.

Reliable Information from Consistent Monitoring

Typical blood draws for NICU babies can cause information gaps as they are usually  only performed twice a day. This can be problematic in cases where more frequent monitoring of these biomarkers is required to monitor the infant’s condition.

“We know that premature babies have a better chance of survival if they get a high quality of care in the first month of birth,” said Jong-Hoon Kim, PhD, Associate Professor at the WSU School of Electrical Engineering and Computer Science, in a WSU news release. “Normally, in a hospital environment, they draw blood from the baby twice a day, so they just get two data points. This device is a non-invasive way to provide real-time monitoring of the electrolyte concentration of babies.”

Kim is a co-corresponding author of the WSU study published in the peer-reviewed journal Biosensors and Bioelectronics, titled, “Smart Bioelectronic Pacifier for Real-Time Continuous Monitoring of Salivary Electrolytes.”

The smart pacifier (above) developed by researchers at the Washington State University School of Electrical Engineering and Computer Science—in collaboration with scientists in two South Korean institutions—provides continuous monitoring of sodium and potassium ion levels. This can help detect and prevent potentially dangerous dehydration issues in NICU babies without invasive blood draws for traditional clinical laboratory testing. (Photo copyright: University of Washington.)

How the Smart Pacifier Works

The miniature system developed by the WSU researchers utilizes a typical, commercially available pacifier outfitted with ion-selective sensors, flexible circuits, and microfluidic channels that monitor salivary electrolytes. These flexible, microfluidic channels attract the saliva when the pacifier is in the infant’s mouth which enables continuous and efficient saliva collection without the need for any type of pumping system. The gathered data is relayed wirelessly to caregivers using Bluetooth technology.

When the researchers tested their smart pacifier on infants, they discovered that the results captured from the device were comparable to information obtained from normal blood draws and standard clinical laboratory tests. Kim noted in the press release that technology currently in use to test infant saliva for electrolytes tend to be bulky, rigid devices that require a separate sample collection.

“You often see NICU pictures where babies are hooked up to a bunch of wires to check their health conditions such as their heart rate, the respiratory rate, body temperature, and blood pressure,” said Kim in the press release. “We want to get rid of those wires.”

The researchers intend to make the components for the device more affordable and recyclable. They also plan to perform testing for their smart pacifier on larger test groups to prove efficacy and hope the gadget will help make NICU treatment less disruptive for infant patients.

Co-authors on the WSU study include researchers from the Georgia Institute of Technology, and Pukyong National University and Yonsei University College of Medicine in South Korea.

Before the ‘Smart’ Pacifier Were ‘Smart’ Diapers!

Going as far back as 2013, Dark Daily has covered research into the use of sensors placed in wearables and disposables to detect and monitor health issues.

In “New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—then Alerts Baby’s Doctor,” Dark Daily reported on how the advent of digital technology and smartphones was moving medical laboratory testing out of the central laboratory and into the bedside, homes, and into diapers!

And this past fall, 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 on researchers who were combining diagnostics with existing products to help medical professionals and patients monitor bodily functions and chronic diseases.

“It should be noted that the ability to put reliable diagnostic sensors in disposables like diapers has been around for almost a decade and does not seem to have caught on with either caregivers or the public,” said Robert Michel, Editor-in-Chief of Dark Daily and its sister publication, The Dark Report. “Because the researchers who developed the pacifier are attempting to solve a problem for NICU babies, this solution might find acceptance.”

This is another example of how researchers are thinking outside the box as to how to measure critical biomarkers without the need to send a specimen to the core clinical laboratory and wait hours—sometimes overnight—for results.

JP Schlingman

Related Information:

Smart Pacifier Developed to Monitor Infant Health in Hospitals

Smart Bioelectronic Pacifier for Real-time Continuous Monitoring of Salivary Electrolytes

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

New ‘Smart Diaper’ Tests Baby’s Urine for Urinary Tract Infections, Dehydration, and Kidney Problems—then Alerts Baby’s Doctor

University of Washington Researchers Develop Home Blood Clotting Clinical Laboratory Test That Uses a Smartphone and a Single Drop of Blood

UW scientists believe their at-home test could help more people on anticoagulants monitor their clotting levels and avoid blood clots

In a proof-of-concept study,researchers at the University of Washington (UW) are developing a new smartphone-based technology/application designed to enable people on anticoagulants such as warfarin to monitor their clotting levels from the comfort of their homes. Should this new test methodology prove successful, clinical laboratories may have yet one more source of competition from this at-home PT/INR test solution.

PT/INR (prothrombin time with an international normalized ratio) is one of the most frequently performed clinical laboratory blood tests. This well-proven assay helps physicians monitor clotting in patients taking certain anticoagulation medications.

However, the process can be onerous for those on anticoagulation drugs. Users of this type of medication must have their blood tested regularly—typically by a clinical laboratory—to ensure the medication is working effectively. When not, a doctor visit is required to adjust the amount of the medication in the bloodstream.

Alternatively, where a state’s scope of practice law permits, pharmacists can perform a point-of-care test for the patient, thus allowing the pharmacist to appropriately adjust the patient’s prescription.

Though in the early stages of its development, were the UW’s new smartphone-based blood clotting test to be cleared by the federal Food and Drug Administration (FDA), then users would only need to see a doctor when their readings went and stayed out of range, according to Clinical Lab Products (CLP).

The UW researchers published their findings in the journal Nature Communications, titled, “Micro-Mechanical Blood Clot Testing Using Smartphones.”

Enabling Patients to Test Their Blood More Frequently

More than eight million Americans with mechanical heart valves or other cardiac conditions take anticoagulants, and 55% of people taking those medication say they fear experiencing life-threatening bleeding, according to the National Blood Clot Alliance.

They have reason to be worried. Even when taking an anticoagulation drug, its level may not stay within therapeutic range due to the effects of food and other medications, experts say. 

“In the US, most people are only in what we call the ‘desirable range’ of PT/INR levels about 64% of the time. This number is even lower—only about 40% of the time—in countries such as India or Uganda, where there is less frequent testing. We need to make it easier for people to test more frequently,” said anesthesiologist and co-author of the study Kelly Michaelsen, MD, PhD, UW Assistant Professor of Anesthesiology and Pain Medicine, in a UW news release.

Shyam Gollakota, PhD
“Back in the day, doctors used to manually rock tubes of blood back and forth to monitor how long it took a clot to form. This, however, requires a lot of blood, making it infeasible to use in home settings,” said senior study author Shyam Gollakota, PhD (above), professor and head of the Networks and Mobile Systems Lab at UW’s Paul G. Allen School of Computer Science and Engineering, in the UW news release. “The creative leap we make here is that we’re showing that by using the vibration motor on a smartphone, our algorithms can do the same thing, except with a single drop of blood. And we get accuracy similar to the best commercially available techniques [used by clinical laboratories].” (Photo copyright: University of Washington.)

How UW’s Smartphone-based Blood Clotting Test Works

The UW researchers were motived by the success of home continuous glucose monitors, which enable diabetics to continually track their blood glucose levels.

According to the Nature Communications paper, here’s how UW’s “smartphone-based micro-mechanical clot detection system” works:

  • Samples of blood plasma and whole blood are placed into a thimble-size plastic cup.
  • The cup includes a small copper particle and thromboplastin activator.
  • When the smartphone is turned on and vibrating, the cup (which is mounted on an attachment) moves beneath the phone’s camera.
  • Video analytic algorithms running on the smartphone track the motion of the copper particle.
  • If blood clots, the “viscous mixture” slows and stops.
  • PT/INR values can be determined in less than a minute.  

“Our system visually tracks the micro-mechanical movements of a small copper particle in a cup with either a single drop of whole blood or plasma and the addition of activators,” the researchers wrote in Nature Communications. “As the blood clots, it forms a network that tightens. And in that process, the particle goes from happily bouncing around to no longer moving,” Michaelsen explained.

The system produced these results:

  • 140 de-identified plasma samples: PT/INR with inter-class correlation coefficients of 0.963 and 0.966.
  • 79 de-identified whole blood samples: 0.974 for both PT/INR.

Another At-home Test That Could Impact Clinical Laboratories

The UW scientists intend to test the system with patients in their homes, and in areas and countries with limited testing resources, Medical Device Network reported.

Should UW’s smartphone-based blood-clotting test be cleared by the FDA, there could be a ready market for it. But it will need to be offered it at a price competitive with current clinical laboratory assays for blood clotting, as well as with the current point-of-care tests in use today.

Nevertheless, UW’s work is the latest example of a self-testing methodology that could become a new competitor for clinical laboratories. This may motivate medical laboratories to keep PT/INR testing costs low, while also reporting quick and accurate results to physicians and patients on anticoagulants.

Alternatively, innovative clinical laboratories could develop a patient management service to oversee a patient’s self-testing at home and coordinate delivery of the results with the patient’s physician and pharmacist. This approach would enable the lab to add value for which it could be reimbursed. 

Donna Marie Pocius

Related Information:

Smartphone App Can Vibrate a Single Drop of Blood to Determine How Well It Clots

Blood Coagulation Testing Using Smartphones

Micro-Mechanical Blood Clot Testing Using Smartphones

55% of Americans Taking Blood Thinners Indicate They Fear Suffering from Major Blooding, 73% More Cautious with Routine Activities to Avoid Risk

University of Washington Develops New Blood Clotting Test

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

Abbott sends the SARS-CoV-2 test results directly to patients’ smartphones, which can be displayed to gain entrance into areas requiring proof of COVID-19 testing

There is no greater example that COVID-19 is a major force for change in the clinical laboratory industry than the fact that—though the US federal government pays 50% of the nation’s total annual healthcare spend of $3.5 trillion—it recently spent $760 million to purchase 150 million COVID-19 tests from Abbott Laboratories (NYSE:ABT), an American multinational medical devices and healthcare company headquartered in Abbott Park, Ill., “to expand strategic, evidence-based testing in the United States,” according to the company’s website.

In August, the federal Food and Drug Administration (FDA) granted an emergency use authorization (EUA) to Abbott for its BinaxNOW portable rapid-response COVID-19 antigen (Ag) test. The credit-card sized test costs $5 and can return clinical laboratory test results in minutes, rather than hours, days, or in some cases, weeks, the Wall Street Journal (WSJ) reported.

The test includes a free smartphone app called NAVICA, which enables those tested to receive their test results directly on their mobile devices—bypassing the patient’s primary care physicians.

According to Abbott’s website, the app “allows people who test negative to get an encrypted temporary digital NAVICA Pass, similar to an airline boarding pass. NAVICA-enabled organizations will be able to verify an individual’s negative COVID-19 test results by scanning the individual’s digital NAVICA Pass to facilitate entry into facilities.”

This feature of Abbott’s new COVID-19 test is a good example of how quickly innovation in the medical laboratory testing profession is bringing new features and new capabilities to the marketplace. By marrying the SARS-CoV-2 test with the NAVICA Pass feature, Abbott hopes to deliver increased value—not just to physicians and their patients—but also to employers with employee screening programs and federal government programs designed to screen federal employees, as well as being used for screening travelers at airports and other transportation hubs.

Abbott appears to be banking that in the future such identification will be required to “enter organizations and other places where people gather,” as the company’s website states.

Testing Limited to CLIA-Certified Clinical Laboratories

An HHS news release announcing the government’s planned distribution of the BinaxNOW tests stated that “Testing will be potentially deployed to schools and to assist with serving other special needs populations.”

In the news release, Alex Azar, HHS Secretary, said, “By strategically distributing 150 million of these tests to where they’re needed most, we can track the virus like never before and protect millions of Americans at risk in especially vulnerable situations.”

The EUA adds that “Testing of nasal swab specimens using [BinaxNOW] … is limited to laboratories certified under CLIA that meet the requirements to perform high, moderate, or waived complexity tests. This test is authorized for use at the [point of care], i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.”

The FDA’s EUA describes the BinaxNOW portable rapid-response COVID-19 antigen test (above) as “a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.” The test costs $5 and Abbott sends results directly to the patient’s smartphone using the free NAVICA app included with the test. (Photo copyright: Abbott Laboratories.)

IVD Companies See Boom in COVID-19 Test Sales

Demand for COVID-19 testing has created opportunities for in vitro diagnostics (IVD) companies that can develop and bring tests to market quickly. 

Recent issues of Dark Daily’s sister print publication—The Dark Report (TDR)—covered IVD companies’ second quarter (Q2) boom in sales of COVID-19 instruments and tests, while also noting a fall-off in routine clinical laboratory testing during the COVID-19 pandemic. 

Abbott Laboratories saw molecular diagnostics sales increase 241% in Q2 driven by $283 million in sales of COVID-19 testing, while rapid diagnostic COVID-19 testing rose 11% on $180 million in sales in Q2, TDR reported, based on Abbott data.

“There is huge economic incentive for diagnostic companies to develop technologies that can be used to create rapid tests that are cheap to perform,” said Robert Michel, Publisher and Editor-in-Chief of TDR and Dark Daily. “In this sense, COVID is a major force for change.”

“This new COVID-19 antigen test is an important addition to available tests because the results can be read in minutes, right off the testing card,” said Jeff Shuren, MD, JD (above), Director of the FDA’s Center for Devices and Radiological Health (CDRH), in an FDA news release announcing the federal government’s $760 million purchase of 150 million Abbott BinaxNOW rapid-response antigen COVID-19 tests. “This means people will know if they have the virus in almost real-time. Due to its simpler design and the large number of tests the company anticipates making in the coming months, this new antigen test is an important advancement in our fight against the pandemic.” (Photo copyright: The New York Times.)

Abbott Invests in Proving BinaxNOW’s Capabilities

Abbott has a lot riding on the BinaxNOW test. Its portable, rapid molecular ID NOW COVID-19 test was touted by President Trump during a White House press briefing in March as “a whole new ballgame.” But then, researchers at New York University (NYU) published study data that questioned the accuracy and reliability of the test, which Dark Daily covered in “Abbott Labs’ ID NOW COVID-19 Rapid Molecular Test Continues to Face Scrutiny Over False Negatives.”

Thus, Abbott is determined to ensure this product launch is successful and that the test works as promised. According to a news release, “In data submitted to the FDA from a clinical study conducted by Abbott with several leading US research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.”

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, PhD, professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, in the Abbott news release. “With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.”

Abbott has invested hundreds of millions of dollars in two manufacturing facilities where the tests will be made, John Hackett Jr, PhD, an immunologist and Abbott’s Divisional Vice President Applied Research and Technology, and lead scientist on the BinaxNOW project, told The Atlantic.

“Our nation’s frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic,” said Charles Chiu, MD, PhD, professor of Laboratory Medicine at University of California, San Francisco, in the Abbott news release. “The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times, and greatly expand access to people who need it.”

However, other experts are not so sure. In the Atlantic article, Michael Mina MD, PhD, Assistant Professor Epidemiology at Harvard’s T.H. Chan School of Public Health, voiced the need to test both asymptomatic and pre-symptomatic people. “This is the type of [COVID-19] test we have been waiting for—but may not be the test.”

Nevertheless, the federal government’s investment is significant. Abbott plans to start shipping tens of millions of tests in September and produce 50 million tests per month starting in October, Forbes reported.

Shifting Clinical Laboratory Paradigms

BinaxNOW will be performed without doctors’ orders, in a variety of locations, and results go directly to patients’ smartphone—without a pathologist’s interpretation and medical laboratory report. This is new ground and the impact on non-CLIA labs, and on healthcare in general, is yet to be seen.

Clinical laboratory managers will want to monitor the rise of rapid-response tests that can be easily accessed, conducted, and reported on without physician input. 

—Donna Marie Pocius

Related Information:

Trump Administration Will Deploy 150 Million Rapid Tests in 2020

In Vitro Diagnostics Firms Report Boom in Sales of COVID-19 Instruments, Tests

FDA Authorizes First Diagnostic Test Where Results Can Be Read Directly from Testing Card

Abbott’s Fast, $5, 15-Minute Easy-to-Use COVID-19 Antigen Test Receives FDA Emergency Use Authorization; Mobile App Displays Test Results to Help Our Return to Daily Life; Ramping Production to 50 Million Tests a Month

Performance of the Rapid Nucleic Acid Amplification by Abbott ID NOW COVID-19 in Nasopharyngeal Swabs Transported in Viral Media and Dry Nasal Swabs, in a New York City Academic Institution

Trump to Announce Deal with Abbott Laboratories for 150 Million Rapid COVID-19 Tests

Abbott Labs’ ID NOW COVID-19 Rapid Molecular Test Continues to Face Scrutiny Over False Negatives

Abbott Provides Update on ID NOW

A New Era of Coronavirus Testing is About to Begin

U.S. Approves Abbott Labs’ $5 Mass-Scale COVID-19 Test

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