The rapid diagnostic test costs less than $5 per unit and can be adapted for other diseases, the developers say, which opens a slew of possibilities for clinical laboratories
Just as the SARS-CoV-2 coronavirus spurred deployment of new vaccine technology based on messenger RNA (mRNA), the COVID-19 pandemic also could prove to be a watershed for in vitro diagnostics (IVD) innovation in ways that benefit clinical laboratories.
A Penn Medicine news release noted that “The RAPID technology … transforms the binding event between the SARS-CoV-2 viral spike protein and its receptor in the human body, the protein ACE2 (which provides the entry point for the coronavirus to hook into and infect human cells), into an electrical signal that clinicians and technicians can detect. That signal allows the test to discriminate between infected and healthy human samples. The signal can be read through a desktop instrument or a smartphone.”
Though still in its early stages, the technique potentially offers dramatically lower costs and faster results than traditional RT-PCR (reverse transcription polymerase chain reaction) molecular tests. Moreover, the RAPID technology might be useful for identifying other types of biomarkers and could be the basis for diagnostic tests that help reduce the cost-per-test in medical laboratory testing while providing comparable sensitivity and specificity to existing methodologies.
Clinical trials began on January 5, 2021, and the Penn Medicine researchers say the IVD test technology can be applied to other infectious diseases, which, if proven accurate, would be a boon to clinical laboratory testing.
Diagnostic Test Results in Four Minutes for Less than $5/Test
According to the news release, the RAPID 1.0 (Real-time Accurate Portable Impedimetric Detection prototype 1.0) biosensor test costs less than $5 and can deliver results in four minutes. The researchers reported overall accuracy of 87.1% on (139) nasal swab samples and 90% on (50) saliva samples.
The technology uses electrodes that can be mass-produced at low cost on commercially-available screen printers, the researchers said. Results can be read on electronic devices connected to a PC or smartphone.
RAPID 1.0 (above) is a low-cost COVID-19 diagnostic test developed at the César de la Fuente clinical laboratory at the Perelman School of Medicine University of Pennsylvania in Philadelphia. At less than $5/test, plus the ability to be adapted to other diseases, clinical laboratories performing disease screenings in rural or remote locations may have a new tool in the fight against infections. (Photo copyright: University of Pennsylvania.)
Does Penn Medicine’s RAPID 1.0 Test Replace Traditional RT-PCR Testing?
In their published study, the Penn Medicine researchers cited the need for “fast, reliable, inexpensive, and scalable point-of-care diagnostics.”
RT-PCR tests, they said, “are limited by their requirement of a large laboratory space, high reagent costs, multistep sample preparation, and the potential for cross-contamination. Moreover, results usually take hours to days to become available.”
Researchers who have studied the SARS-CoV-2 coronavirus know that it uses a spike-like protein to bind to angiotensin-converting enzyme 2 (ACE2) receptors on the surfaces of human cells.
As described in Penn Medicine’s published study, the biosensor contains ACE2 and other biochemical agents anchored to an electrode. When the SARS-CoV-2 coronavirus attaches to the ACE2, the biosensor transforms the chemical reaction into an electrical signal that can be measured on a device known as a potentiostat.
The researchers tested their RAPID 1.0 technology with two commercially available potentiostat models:
The researchers initially developed the electrode as a printed circuit board, which is relatively expensive. To reduce costs, they constructed a version that uses filter paper as the main component. The researchers noted that one screen printer in a lab can produce 35,000 electrodes per day, including time needed to incorporate the chemical elements. “However, it must be noted that these steps can be fully automated into a production line for industrial purposes, drastically reducing time requirements,” they wrote.
The test can be performed at room temperature, they added, and total cost per unit is $4.67. Much of that—$4.50—is for functionalizing the ACE2 recognition agent. The cost for the bare electrode is just seven cents.
“The overall cost of RAPID may be further reduced through recombinant production of ACE2 and ACE2 variants,” the researchers said, adding that the RAPID 1.0 test can detect the SARS-CoV-2 coronavirus at low concentrations correlating to the earliest stages of the COVID-19 disease.
The Penn Medicine research team was led by César de la Fuente, PhD (above), an Assistant Professor in Psychiatry, Microbiology, Chemical and Biomolecular Engineering and Bioengineering at the Perelman School of Medicine. “Prior to the pandemic, our lab was working on diagnostics for bacterial infections,” he said in the Penn Medicine news release. “But then, COVID-19 hit. We felt a responsibility to use our expertise to help—and the diagnostic space was ripe for improvements.” (Photo copyright: University of Pennsylvania.)
Testing Penn Medicine’s RAPID 1.0 Test
The researchers evaluated the technology in blinded tests with clinical samples from the Hospital of the University of Pennsylvania. The evaluation included 139 nasal swab samples, of which 109 were determined to be COVID-19 positive by RT-PCR tests and clinical assessments. Among these, the RAPID test successfully detected the SARS-CoV-2 coronavirus in 91 samples, for a sensitivity rate of 83.5%. One sample was from a patient diagnosed with the highly contagious SARS-CoV-2 Alpha variant B.1.1.7, which the test correctly identified as positive.
Among the 30 samples determined to be COVID negative, the RAPID test scored a specificity rate of 100%, meaning no false positives. Overall accuracy, including sensitivity and specificity, was 87.1%.
The researchers also analyzed 50 saliva samples: 13 COVID-positive and 37 COVID-negative. The test correctly identified all 13 positive samples but produced five false-positives among the 37 negative samples, for a specificity rate of 86.5%. The researchers speculated that this could be due to interactions between ACE2 and other biomolecules in the saliva but suggested that performance “will improve when using fresh saliva samples at the point-of-care.”
Are There Other Applications for the RAPID Test?
The Penn Medicine news release said the RAPID technology can be adapted to detect other viruses, including those that cause Influenza and sexually-transmitted diseases.
Robert Michel, Editor-in-Chief of Dark Daily and its sister publication The Dark Report, said the test points to one silver lining in the COVID-19 pandemic. “Researchers around the world intensified their work to find ways to identify the SARS-CoV-2 virus that are faster, cheaper, and more accurate than the diagnostic technologies that existed at the time of the outbreak. In this regard, the COVID-19 pandemic may have accelerated the development and refinement of useful diagnostic technologies that will disrupt long-established methods of testing.”
Marcelo Der Torossian Torres, PhD, postdoctoral researcher at Penn Medicine and lead author of the study, said in the news release, “Quick and reliable tests like RAPID allow for high-frequency testing, which can help identify asymptomatic individuals who, once they learn they are infected, will stay home and decrease spread.
“We envision this type of test being able to be used at high-populated locations such as schools, airports, stadiums, companies—or even in one’s own home,” he added.
Clinical laboratory managers may want to stay current on the development and possible commercialization of the RAPID 1.0 (Real-time Accurate Portable Impedimetric Detection prototype 1.0) biosensor test by the research team at Penn Medicine.
Online reputation management is increasingly becoming a critical function that all providers, including clinical laboratories, must address or risk losing revenue
Recent surveys cite growing evidence that Facebook (NASDAQ:FB) and online review sites such as Yelp (NYSE:YELP) are swiftly becoming healthcare consumers’ preferred sources for researching doctors, hospitals, medical laboratories, and other medical service providers.
Healthcare consumers are using the Internet to review information
on healthcare providers prior to visits. More important, data show a majority
of Americans share their healthcare experiences publicly online following
visits with providers.
This should serve as a wakeup call for clinical laboratories and anatomic pathology groups that have not developed effective social media strategies, as they are clearly among the health services being evaluated.
More than half of Americans (51%) reported sharing their healthcare experiences online, an increase of 65% over just one year ago;
Among Millennials (people born between 1981 and 1996) that number jumps to 70%, a 94% increase over last year;
70% of Americans overall say online ratings and reviews influenced their choices of physicians and facilities;
More than 40% of respondents admitted they researched doctors online even after being referred to them by another healthcare professional.
“The survey results underscore the significance of online ratings and reviews as online reputation management for physicians becomes ever-more important in today’s healthcare environment,” said Aaron Clifford, Senior Vice President of Marketing at Binary Fountain, in a statement. “As patients are becoming more vocal about their healthcare experiences, healthcare organizations need to play a more active role in compiling, reviewing, and responding to patient feedback if they want to compete in today’s marketplace.”
Healthcare Dive also noted that Millennials are likely to consider online reviews and ratings of healthcare professionals to be trustworthy.
97% of 24- to 34-year-olds report believing
online comments are reliable;
While 100% of the 18- to 24-year-olds surveyed felt
similarly.
Pathologists and clinical laboratory administrators should
consider the two findings above as evidence that a major change has already
happened in how the younger generations look for—and select—their hospitals,
their physicians, and their clinical laboratory providers. Thus, every
pathology group and clinical laboratory should have a business strategy for
managing the Internet presence of their labs. Failure to do so means that
competing labs that do a good job of managing their Internet presence will be
more successful at winning the lab testing business of Gen Xers (born
1965-1980), Millennials (Gen Y, born 1981-1996), and Gen Z (born 1997-2009).
In addition, the survey discovered that the most important
qualities consumers look for in a doctor are:
Friendly and caring attitudes;
Physicians’ ability to answer questions; and
Thoroughness of examinations.
Those polled reported the most frustrating issues when
dealing with healthcare professionals were:
Office wait times;
Cost and payment concerns;
Wait times for exam and medical laboratory
results; and
Scheduling appointments.
It’s All in a Word
Earlier this year, Healthcare Dive also reported on research that examined online reviews and their content conducted by Penn Medicine. Researchers at the University of Pennsylvania used digital tools and data analytics to help healthcare providers better understand and improve the patient experience.
The researchers analyzed 51,376 online reviews about 1,566
hospitals posted on Yelp over a 12-year period. They published their findings in
the Journal
of General Internal Medicine (JGIM).
They concluded the word most often found in positive Yelp
reviews was “friendly.” Their example of how positive review writers used this word:
“The doctors, nurses, and X-ray technician who helped me out were all so cool
and friendly. It really restored my faith in humanity after I got hit on my
bike.”
Other words the researchers commonly found in good online
reviews include “great, staff, and very.”
“Told” was the word most often found in negative reviews. The
researchers’ example: “I constantly told them that none of that was true and
the nurse there wouldn’t believe me.” It appears from the JGIM study
that Millennials often felt healthcare professionals did not listen to them.
The researchers identified “worst, hours, rude, said, no and
not” as other words often found in negative reviews.
“As providers, we need to take a moment to think about how we talk in hospitals, but also what patients are hearing,” said lead author of the Penn Medicine study Anish Agarwal, MD, Assistant Professor of Emergency Medicine at the University of Pennsylvania. “I may say something, but the way it’s heard and interpreted and then processed within patients when they’re going through a vulnerable time can be different.” (Photo copyright: University of Pennsylvania.)
Half of Millennials Prefer Internet Research and Online
Virtual Healthcare
Another survey conducted by Harmony Healthcare IT, a health data management firm based in South Bend, Ind., found that more millennials are researching the Internet for medical advice in lieu of actual doctor visits.
PC Magazine reported Harmony Healthcare IT’s survey found:
73% of Millennials reported following medical
advice found online instead of going to a doctor; and
93% reported researching medical conditions
online in addition to a doctor visit.
The survey also found that 48% of millennials trust online
resources for medical information and that 48% prefer virtual doctor office
visits over in-person visits.
In addition, 24% of this age group have gone five or more years without a physical and 57% prefer high-deductible health plans (HDHPs).
“With an emphasis on convenience, low cost, and technology, it will be interesting to see how this generation helps shape the future of health and how both patients and providers will adapt to those changes along the way,” Harmony Healthcare IT wrote in a blog post.
The results of these surveys illustrate why clinical laboratories
and anatomic pathology groups must have a social media strategy for managing
their reputations and presence on the Internet, especially where Millennials
are concerned.
That strategy should include easy and informative ways for
patients to learn about medical laboratory services, pricing of lab tests,
quality of work, and methods consumers can use to leave online feedback and
receive responses to their comments.
PwC report indicates deal-making may generate long-term savings, but adds to higher medical costs as hospital systems dominate markets and drive up prices
Consolidation of big hospital health networks combined with a loss of independent doctor practices has changed the healthcare landscape in recent years, and clinical laboratories and anatomic pathology groups have been directly impacted. Now, those trends, along with increased access to care, are expected to push employer medical cost up by as much as 6% in 2019.
The continued deal-making is bad news for medical laboratories, since super-sized hospital systems typically trim the budgets of laboratory and other services to improve operating efficiencies.
At the same time, more doctors are practicing as employees of hospitals, health networks, and medical groups. This physician consolidation presents challenges for independent clinical laboratories, which often lose test orders to in-house hospital labs when physicians no longer practice independently.
Consumer Demand for Access to Healthcare Will Drive Costs Higher
Consolidation-related pressures are not the only forces pushing medical costs higher. HRI expects a third factor to inflate medical costs in 2019—consumer pressure for more ways to access care.
The growth of care options such as: retail clinics, telemedicine, urgent care, and on-site employer health clinics may bring prices down over time, however increased utilization often raises employers’ healthcare costs in the short-term as workers take advantage of easier ways to access care, the report states.
Less Flu and High-Performing Health Networks Expected to Lower Costs
Conversely, HRI believes a milder flu season in 2018-2019 may help keep spending increases in check. Additionally, the growing number of healthcare advocates in the workplace who educate employees on the use of their healthcare benefits, plus the creation of high-performing health networks—both of which emphasize high-quality care alongside cost savings—should serve to deflate healthcare spending.
In an interview with FierceHealthcare, Barbara Gniewek, a Health Services Principal at PwC, compared attempts to control healthcare spending to a balloon. “Every time you squeeze one area” another issue crops up, she said.
Employer healthcare costs have risen 5.5% to 7% annually for each of the past five years. HRI contends downward pressure on healthcare prices overall—not just drug prices—may be the only remaining way for employers and health plans to keep healthcare spending from outpacing inflation.
“Efforts by employers to cut utilization have mostly run their course,” the report states. “Employers and consumers are plagued by high prices that continue to grow because of new, expensive medical services and drugs, and other factors, such as consolidation.”
While the 2019 spending number pales in comparison to the annual double-digit growth in healthcare spending two decades ago, Gniewek told RevCycleIntelligence the inflation news should not be viewed as positive.
“While some people are relieved that it’s not the high rates of 15 or 20 years ago, costs going up at that rate still [are] unsustainable,” Barbara Gniewek, Health Services Principal at PwC, told RevCycleIntelligence. “We still haven’t figured out how to control healthcare costs and we still don’t have the type of healthcare that we need.” (Photo copyright: PricewaterhouseCoopers.)
Giant Wave of Consolidation
In theory, healthcare consolidation should create economies of scale that result in efficiencies that drive costs lower. However, reality can be much different, since short-term prices often rise when one health system suddenly dominates a market.
“We need to start getting to the point where we pull out the excess redundancies in the system and be able to monetize that in terms of savings,” Gniewek told RevCycleIntelligence. “We just haven’t seen that happen yet. It’s been more, ‘I own the market, so I can drive up the prices.’ As the government and employers demand better price control and want to do some direct contracting or high-performing networks, then eventually consolidations will be more efficient.”
“It’s both ‘horizontal’ and ‘vertical,’ meaning hospitals aren’t just buying other hospitals, they’re picking up physician practices, rehabilitation facilities, and other ancillary healthcare providers,” a Knowledge@Whartonarticle on hospital consolidation stated.
Of the 115 health-system and hospital mergers announced in 2017, 10 were mega-deals involving sellers with net annual revenues of at least $1 billion, PwC noted in its annual report. The largest is a $28.4 billion merger between San Francisco-based Dignity Health and Catholic Health Initiatives of Englewood, Colo., which is expected to close in the coming year, according to a press release.
And a July 2018 report from the National Council on Compensation Insurance (NCCI) notes that though hospital mergers can lead to operating cost reductions for acquired hospitals of 15% to 30%, those reductions usually do not translate into price decreases.
“Research to date shows that hospital mergers increase the average price of hospital services by 6% to 18%. For Medicare, hospital concentration increases costs by increasing the quantity of care, rather than the price of care,” NCCI stated.
Clinical Laboratories May Be Part of Cost Reductions
If the factors fueling today’s increases in healthcare spending—consolidation and convenience—continue pushing costs higher, clinical laboratories and anatomic pathology groups will most likely be impacted as employers, insurers, and consumers look for ways to cut medical costs.
In this environment, medical laboratories must continually work to deliver more value to providers, patients, and healthcare networks.
Precision medicine programs can benefit from wearable usage data; however, little information has been collected on personalities and behaviors of the device users
Wearables medical devices have the potential to monitor some of the same biomarkers used in medical laboratory tests today. In addition, these mobile technologies can make it possible for clinical laboratories to monitor patients in real time, as well as allow labs to incorporate such into a patient’s historical record of lab test results.
The trend toward personalized medicine (aka, Precision Medicine) is increasing, with many payment programs based on it. Thus, monitoring and correcting activities that cause chronic disease, or work against treatments, is becoming standard procedure for forward-thinking, technically proficient doctors and hospitals. But are patients onboard with all of it?
Activity Trackers for Monitoring Patient Behavior
With the popularity of activity trackers on the rise, researchers are examining their usage patterns to determine how the devices are being utilized, their target market, and ways to encourage sustained use of the gadgets.
A recent article published in Annals of Internal Medicine provided insight regarding who is using this type of wearable device, how activity trackers are being employed, and the length of time consumers will maintain their usage.
“Many people are excited by the potential of using activity trackers to monitor healthy behaviors, but there is very little evidence on who is using them and whether or not use is sustained over time,” Patel stated in a Penn Medicine news release. “We found that, though use grew over time, it really varied depending on individual characteristics like age and income. We also found that once someone started using an activity tracker, sustained use at six months was high at 80%.”
Patel is also Director of the Penn Medicine Nudge Unit, a behavioral design team that is studying the impact that nudges or small interventions may have on healthcare. The team is examining ways in which nudges can influence choices, and also direct medical professionals and patients toward optimal decisions to improve healthcare delivery and results. (Photo copyright: University of Pennsylvania.)
Gaming the Study Improves Usage of Test Devices
To perform the study, 4.4 million members of a national wellness program were invited to take part in data collection. Approximately 55,000 of those individuals actually participated in the study, which involved downloading an app to record pertinent information. Researchers tracked and interpreted the data during a two-year period in 2014 and 2015.
The information analyzed included:
When participants initially activated their tracker;
How often the device was utilized;
The average number of steps taken per day; and,
Sociodemographic characteristics.
The results of the study were not entirely unexpected, but there were surprises:
80% of the people who initially activated the devices were still using them after six months;
Only 0.2% of the invited individuals used the devices in the first year;
However, that number increased to 1.2% during the second year.
The usage of wearable activity trackers was nearly double among younger people than it was for older individuals. In addition, people from households with an annual income of less than $50,000 used the gadgets at lower rates than those at higher income levels.
A mere 0.1% of the potential participants were over 65-years old. However, 90% of individuals in this age group were still using the devices six months after initial activation.
The authors of the study stated that adding game elements, such as points, levels, badges and financial incentives may have played a role in the sustained use of the activity trackers.
“Gamification and financial incentives are commonly used within wellness programs, but their impact has not been well studied,” Patel stated in the news release. “Our findings provide initial evidence suggesting that these types of engagement strategies may show promise for keeping sustained use high. However, more studies are needed to determine the best way to combine these types of engagement strategies with activity trackers to improve health outcomes.”
Most Commonly Used Mobile Activity Tracking Devices
There were 60 different types of wearable activity trackers that could be used by participants for the study. Seventy-six percent of those participants elected to use the FitBit activity tracker. This mobile healthcare device is worn on the wrist like a watch. It monitors activity, exercise, food, weight, and sleep to provide consumers with real-time data about their activities.
The data collected by the device is sent automatically and wirelessly to the user’s phone or computer. Individuals then can use the FitBit dashboard to view their progress through online charts and graphs. The dashboard also offers progress notifications to the consumer and gives achievement badges when established goals have been reached.
The second most common activity trackers used were Apple devices, such as Apple Watches, which were chosen by 9% of the participants.
Biometric data on patients’ behavior and activities that is collected and transmitted from mobile devices has swiftly become critical data doctors use in precision medicine diagnoses and treatments. Clinical laboratories will likely be including biomarker data taken by these devices in their testing and procedures in the future. The only question is how quickly the data generated by such devices becomes acceptable to add to a patient’s permanent health record.
80% of US employers are using financial incentives in wellness programs, and Penn Medicine research suggests better incentive design is needed to get people to exercise
In recent years, there’s been plenty of headlines about wellness programs offered by employers and health insurers. Data show that such programs are cost-effective. But, until now, there were few studies about employees’ attitudes toward wellness programs. Because some of these wellness programs incorporate clinical laboratory testing, medical labs have a stake in their future.
The fact is that companies want healthier employees and they’re willing to pay for it. Experts say about 80% of US employers use financial incentives in worker wellness programs. And for each dollar a company spends on a wellness program, it saves about $3 in medical costs, according to an article the journal Health Affairs. (more…)
