Multiple recent studies reveal a substantial number of patients continue to delay needed healthcare in the months since the onset of the SARS-CoV-2 outbreak
Based on an analysis of hospital emergency department (ED) usage, federal researchers concluded that patients continue to be cautious when visiting healthcare providers, including clinical laboratories, and that people are altering how they seek and utilize emergency care due to the COVID-19 pandemic. This not only reduces the number of typical test orders from the ER to the hospital lab, but also reduces the source of inpatient admissions.
Between March 29 and April 25 of this year, facilities the CDC examined recorded 1.2 million visits to EDs, compared to 2.1 million visits between March 31 and April 27 of last year. The steepest decrease in patient demographics was for individuals under the age of 14, women, and people living in the Northeast region.
The CDC’s data showed that 12% of ED visits were for children in pre-pandemic 2019, which dropped to 6% during the 2020 pandemic period. The CDC included ED visits from hospitals in 47 states (excluding Hawaii, South Dakota, and Wyoming) and captured information from approximately 73% of ED visits in the US.
Delaying Healthcare Visits Worsens Medical Conditions, Reduces Revenues
ED visits are an important referral source for inpatient admissions. Fewer patients in EDs means lost revenue for hospitals. However, one positive aspect of the waning number of ED visits is that it may be keeping patients with non-emergency situations away from emergency departments, thus reducing the overuse of costly ED visits. But healthcare professionals are concerned that individuals also may be avoiding or delaying care when needed, which could worsen medical situations and outcomes.
“We saw people, with COVID-19 and without, coming into the ED who were very ill,” Vik Reddy, MD, Chief Medical Officer at Wellstar Kennestone Hospital and Wellstar Windy Hill Hospital in the Atlanta area, told Modern Healthcare. He noted that some patients delayed care for critical non-COVID-19 illnesses. “The good news is that we’re seeing that trend reverse this time around. It was scary in March when we knew that people weren’t coming into the ED for heart attacks.”
The NSSP’s analysis concluded that the report’s findings were subject to at least four limitations:
The number of hospitals reporting to NSSP changes over time as facilities are added or closed. For example, 3,173 hospitals reported data in April of 2019, while 3,467 reported data in April 2020.
Diagnostic categories rely on the use of specific codes, which were missing in 20% of the ED visits reported.
NSSP coverage is not uniform across or within all the participating states.
The analysis is limited only to ED visits and does not take into account patients who did not go to an ED, but instead received treatment in other healthcare environments, such as urgent care clinics.
The graphics above are taken from a Washington Post article which reported that the newspaper’s analysis of smartphone location data of hospital traffic in 2020 showed the “drop” in hospital usage had turned into “a crash,” compared to the same two months last year, and that, “As in many other industries, those lost visits represented a widespread financial crisis for hospitals and other healthcare providers, even in places the novel coronavirus hardly touched.” (Graphics copyright: The Washington Post.)
Additional Studies Show Patients Avoiding Hospital EDs, Delaying Care
Other sources also are reporting similar findings regarding consumer attitudes towards seeking medical care during the COVID-19 pandemic. A PricewaterhouseCoopers survey released in May found that about 45% of 2,500 consumers surveyed plan to forgo their annual physical in 2020, due to the pandemic, Modern Healthcare reported.
In addition, an Optum Consumer Pulse Survey released in May found that nearly 20% of 700 surveyed individuals stated they were likely to avoid hospital EDs even if they were showing signs of a heart attack or appendicitis. Another 40% stated they were likely to avoid the ED if they had a cut that required stitches.
In “Americans Are Delaying Medical Care, and It’s Devastating Health-Care Providers,” The Washington Post analyzed hospital use during the pandemic based on smartphone tracking data. WaPo’s report found a significant drop in patients seeking in-person healthcare with many areas across the country reporting a 50% reduction in patients when compared to last year.
The article also states that almost 94 million people have delayed medical care due to the COVID-19 pandemic, and that 66 million of those individuals needed medical care unrelated to the virus but did not receive it.
These studies and others are showing a pattern. The COVID-19 pandemic has changed when and where patients access healthcare, and if the trend continues, it could have a long-term impact on clinical laboratories. Since fewer people are seeking medical care, fewer laboratory tests are being ordered and performed, which means less work and revenue for the nations’ hospital and independent clinical labs.
If the proposed rule becomes final, it may shift some inpatient medical laboratory testing away from hospital labs and to independent clinical laboratories
Medical laboratories in hospitals and health systems already feel the pinch of less test orders originating from their own emergency departments (ED). Now, more tests associated with inpatient care might also shift away from hospital labs due to a new proposed rule from the federal Centers for Medicaid and Medicare Services (CMS) that would move 1,740 specific procedures from inpatient care settings to outpatient ambulatory surgical centers (ACS).
Further, the proposed rule would completely phase out the “inpatient only” (IPO) list of services over a three-year transitional period, with total elimination of the IPO list by Calendar Year (CY) 2024.
If finalized as written, the rule (CMS-1736-P) would have a negative impact on the finances of hospitals laboratories as more patients get their care in outpatient settings instead of their local hospitals.
Conversely, hospital outreach labs that service ambulatory surgical centers and other outpatient settings could have an opportunity to pick up more medical laboratory test referrals.
The proposed rule, titled, “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; New Categories for Hospital Outpatient Department Prior Authorization Process; Clinical Laboratory Fee Schedule: Laboratory Date of Service Policy; Overall Hospital Quality Star Rating Methodology; and Physician-Owned Hospitals,” was published in the Federal Register on August 12, 2020, and is open for comments until 10/05/2020.
“In this proposed rule, we describe the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system.
Moving from Highest Cost Settings to Lower Cost Settings
In the big picture, these changes can save Medicare money. By shifting procedures for Medicare patients from the highest cost settings—hospital inpatient—to lower cost settings, such as outpatient ambulatory surgical centers, and by eliminating the inpatient-only list, physicians have more leeway to determine for themselves whether a patient needs to be hospitalized for any given procedure.
In “Do Hospitals Have a Target on their Back?” healthcare coding and reimbursement consultant, Terry Fletcher, an editorial board member with ICD10monitor, wrote, “Last year, CMS proposed removing certain services from the inpatient-only list and making them available on an outpatient basis, which it said would help lower costs.
“According to the proposal, ambulatory surgical centers would get a payment increase of 2.6%, and CMS estimated total payments to them for 2021 will be about $5.45 billion, an increase of $160 million from this year,” she added.
Fewer Referrals for Inpatient Lab, More for Hospital Outreach Labs
The impact of the proposed rule is predictable—price shopping will ensue, which is what Medicare wants. Thus, with the removal of the inpatient-only procedure list, the clinical laboratories of hospitals and health systems will likely see a reduction in inpatient test orders. But clinical laboratories participating in hospital outreach programs may see an increase in test orders, as doctors transition to more outpatient procedures.
This seemingly simple shift may be more complicated than it appears, however, for both patients and labs. “In general, any routine test is going to be more expensive at a hospital,” Jean Pinder, founder and CEO of ClearHealthCosts, told Cleveland.com.
There may be other concerns as well. Convenience, insurance coverage, and physician recommendations often influence patient decisions about clinical laboratories.
The chart above, taken from the article by Cleveland.com, “compares prices for common clinical laboratory and imaging tests charged by an independent lab and local hospitals. These are charges that a person would pay without insurance reimbursements. Some University Hospitals prices in the chart differ from those on its website because some prices reflect inpatient, hospital-based services. Many factors can affect [a patient’s] final out-of-pocket costs, including health insurance coverage and individual aspects of your medical treatment.” (Graphic and caption copyright: Cleveland.com.)
Change Is the Only Constant
The entire healthcare industry is undergoing change that is unlikely to end any time soon. Clinical laboratory managers who stay aware of trends in the industry and remain informed on regulatory changes, and who look for opportunities as the business landscape evolves, will have the best chance for guiding their labs to success.
That would certainly be true if CMS is able to publish a final rule that shifts a large number of procedures away from inpatient care and categorizes them as outpatient procedures.
Might clinical laboratories soon be called on to conduct mass testing to find people who show little or no symptoms even though they are infected with the coronavirus?
Clinical laboratory managers understand that as demand for COVID-19 testing exceeds supplies, what testing is done is generally performed on symptomatic patients. And yet, it is the asymptomatic individuals—those who are shown to be infected with the SARS-CoV-2 coronavirus, but who experience no symptoms of the illness—who may hold the key to creating effective treatments and vaccinations.
So, as the COVID-19 pandemic persists, scientists are asking why some people who are infected remain asymptomatic, while others die. Why do some patients get severely ill and others do not? Researchers at the University of California San Francisco (UCSF) and Stanford University School of Medicine (Stanford Medicine) are attempting to answer these questions as they investigate viral transmission, masking, immunity, and more.
And pressure is increasing on researchers to find the answer. According to Monica Gandhi, MD, MPH, an infectious disease specialist and Professor of Medicine at UCSF, millions of people may be asymptomatic and unknowingly spreading the virus. Gandhi is also Associate Division Chief (Clinical Operations/Education) of the Division of HIV, Infectious Diseases, and Global Medicine at UCSF’s Zuckerberg San Francisco General Hospital and Trauma Center.
“If we did a mass testing campaign on 300 million Americans right now, I think the rate of asymptomatic infection would be somewhere between 50% and 80% of cases,” she told UCSF Magazine.
On a smaller scale, her statement was borne out. In a study conducted in San Francisco’s Mission District during the first six weeks of the city’s shelter-in-place order, UCSF researchers conducted SARS-CoV-2 reverse transcription-PCR and antibody (Abbott ARCHITECT IgG) testing on 3,000 people. Approximately 53% tested positive for COVID-19 but had no symptoms such as fever, cough, and muscle aches, according to data reported by Carina Marquez, MD, UCSF Assistant Professor of Medicine and co-author of the study, in The Mercury News.
Pandemic Control’s Biggest Challenge: Asymptomatic People
In an editorial in the New England Journal of Medicine (NEJM), Gandhi wrote that transmission of the virus by asymptomatic people is the “Achilles heel of COVID-19 pandemic control.”
In her article, Gandhi compared SARS-CoV-2, the coronavirus that causes COVID-19, to SARS-CoV-1, the coronavirus that caused the 2003 SARS epidemic. One difference lies in how the virus sheds. In the case of SARS-CoV-2, that takes place in the upper respiratory tract, but with SARS-CoV-1, it takes place in the lower tract. In the latter, symptoms are more likely to be detected, Gandhi explained. Thus, asymptomatic carriers of the coronavirus may go undetected.
“Viral loads with SARS-CoV-1, which are associated with symptom onset, peak a median of five days later than viral loads with SARS-CoV-2, which makes symptom-based detection of infection more effective in the case of SARS-CoV-1,” Gandhi wrote. “With influenza, persons with asymptomatic disease generally have lower quantitative viral loads in secretions from the upper respiratory tract than from the lower respiratory tract and a shorter duration of viral shedding than persons with symptoms, which decreases the risk of transmission from paucisymptomatic persons.”
Rick Wright (above), an insurance broker in Redwood City, Calif., was infected with the COVID-19 coronavirus while aboard a Diamond Princess Cruise. He underwent 40 days of isolation, and though he consistently tested positive for the coronavirus, he experienced no symptoms of the illness. “I never felt sick. Not a cough, wheezing, headache. Absolutely nothing,” he told Mercury News. (Photo copyright: The Mercury News.)
Stanford Studies Immune Responses in COVID-19 Patients
Meanwhile, scientists at the Stanford University School of Medicine were on their own quest to find out why COVID-19 causes severe disease in some people and mild symptoms in others.
“One of the great mysteries of COVID-19 infections has been that some people develop severe disease, while others seem to recover quickly. Now, we have some insight into why that happens,” Bali Pulendran, PhD, Stanford Professor of Pathology, Microbiology, and Immunology and Senior Author of the study in a Stanford Medicine news release.
The Stanford research suggested that three molecules—EN-RAGE, TNFSF14, and oncostatin-M—“correlated with disease and increased bacterial products in human plasma” of COVID-19 patients.
“Our multiplex analysis of plasma cytokines revealed enhanced levels of several proinflammatory cytokines and a strong association of the inflammatory mediators EN-RAGE, TNFSF14, and OSM with clinical severity of the disease,” the scientists wrote in Science.
Pulendran hypothesized that the molecules originated in patients’ lungs, which was the infection site.
“These findings reveal how the immune system goes awry during coronavirus infections, leading to severe disease and point to potential therapeutic targets,” Pulendran said in the news release, adding, “These three molecules and their receptors could represent attractive therapeutic targets in combating COVID-19.”
Clinical Laboratories May Do More Testing of Asymptomatic People
The research continues. In a televised news conference, President Trump said COVID-19 testing plays an important role in “preventing transmission of the virus.” Clearly this is true and learning why some people who are infected experience little or no symptoms may be key to defeating COVID-19.
Thus, as the nation reopens, clinical laboratories may want to find ways to offer COVID-19 testing beyond hospitalized symptomatic patients and people who show up at independent labs with doctors’ orders. As supplies permit, laboratory managers may want to partner with providers in their communities to identify people who are asymptomatic and appear to be well, but who may be transmitting the coronavirus.
July data shows some volume gains for providers since June; however, analysts say current predictions depends on progress of the COVID-19 pandemic
Clinical laboratory managers preparing strategic plans for 2020 and 2021 face a basic and key question: when and if they can expect patient volumes and associated lab test referrals to return to pre-COVID-19 pandemic levels.
Some insights into how to answer that question can be found in two separate reports. Separately, healthcare analysts from Advisory Board and Kaufman Hall explored possible COVID-19 case scenarios and implications for providers’ volumes and operating margins for the remaining months of 2020.
The Advisory Board analysts do not see a snap back to pre-pandemic volume levels happening this year. However, they do envision a gradual volume increase that has already started, they reported in “Projecting Volume Recovery through 2020.”
Patient Volumes Depend on COVID-19 Cases
With 200 experts and more than 4,500 member organizations, the Advisory Board, according to its website, “helps leaders and future leaders in the healthcare industry work smarter and faster by providing provocative insights, actionable strategies, and practical tools to support execution.”
In a Radio Advisory broadcast concerning volume outlook for 2020, Anna Yakovenko, Advisory Board Practice Manager, said there are two likely scenarios for patient volumes, each based on COVID-19 having:
An overall plateau of cases;
A potential of a second wave in advance of influenza season.
“We predict that we’ll continue to see a gradual increase in volumes through the year, getting close to pre-COVID-19 volumes,” Anna Yakovenko (above), Advisory Board Practice Manager, said during a Radio Advisory broadcast. She added, “We do think outpatient visits will climb at a higher trajectory, both because they fell the most and because those who delayed care will begin to return. In addition, outpatient surgeries will continue to see an increase probably eclipsing inpatient surgeries, especially those affected by COVID-19 pushing inpatient surgeries to outpatient.” Yakovenko leads best practices research on hospital strategic and operational challenges. (Photo copyright: Advisory Board.)
What If There’s a Second Wave of COVID-19?
The Advisory Board predicts that, even if a COVID-19 second wave occurs earlier than the traditional mid-autumn influenza outbreak, a gradual recovery for providers will still happen. “But then we think we’ll see a dip in volumes—not remotely the level of dip that we saw in March and April—but a dip nonetheless,” Yakovenko said.
In a blog post, Yakovenko cited a Moody’s Investors Service report showing healthcare systems with more patient encounters in May. She wrote that providers need to overcome three pandemic-related issues to get volumes back on track in 2020:
Patients cancelling care because they are anxious;
Loss of jobs and insurance coverage resulting in decreased care demand;
Need for safety precautions, which could result in lower efficiency.
Kaufman Hall Report: Margins Could Go as Low as -11% in Q4 2020
The second report looked at hospital finances and patient volumes. It was done by Kaufman Hall, a Chicago firm providing management consulting services and software. The analysis by Kaufman Hall, released by the American Hospital Association (AHA) titled, “The Effect of COVID-19 on Hospital Financial Health,” predicted median hospital operating margin of -3% in the second quarter (Q2) of 2020, and a possible year-end range of -1% and -11% due to COVID-19. The report noted that—even before COVID-19—hospitals had a modest median margin (money made from operations) of 3.5%.
An AHA news release describes two COVID-19 case scenarios that could affect providers’ margins:
A steady decrease in cases could see median margin of -1% by the fourth quarter of 2020.
“Hospitals have shown some incremental signs of potential financial recovery in recent months,” James Blake (above), Managing Director, Kaufman Hall, said in a news release. “Unfortunately, there is no guarantee these trends will continue, and hospitals still have a long way to go to recover from devastating losses in the early months of the pandemic,” he added. (Photo copyright: Kaufman Hall.)
However, Kaufman Hall’s analysts spotted signs of recovery that were evidenced in data for June to July, when operating margins improved 24% due to pent-up demand for patient services, Healthcare Dive reported.
Their analysis also showed that providers in July had boosts in discharges and surgeries due to resumption of elective procedures. Other data for the seven months ending July 31, and for the month-to-month period June to July, showed:
Operating margins fell 5% year-over-year, but rose 12% month-over-month.
Discharges were down 7% year-over-year, but up 6% month-over-month.
Emergency Department visits fell 17% compared to first seven months in 2019 and were up 10% month-over-month.
Operating Room minutes were down 15% year-to-date and up 3% month-over-month.
Inpatient and outpatient revenues (without CARES funding) are down 5% and 11%, respectively, year-to-date. Inpatient and outpatient revenues June to July increased 6% and 5%, respectively.
“Hospitals saw flat year-over-year gross operating revenue performance, continued high-per-patient expenses, and a fifth consecutive month of volumes falling below 2019 performance and below budget across most metrics. Emergency Department volumes have been hardest hit. Even, so July volumes continued to show some signs of recovery month-over-month,” the Kaufman Hall analysts wrote.
One Provider’s Financial Tale
Allina Health System in Minneapolis, Minn., experienced financial struggles but is reportedly experiencing the type of turnaround the Advisory Board and Kaufman Hall analysts predicted. Allina had an $85 million operating loss in Q2 2020, compared to $14.4 million loss in Q2 2019. But it had positive income for June, according to the Minneapolis/St. Paul Business Journal.
Clearly, the researchers studying patient volumes recognize that it is possible for patient volumes to return to pre-pandemic levels. However, a surge in the number of COVID-19 cases would obviously discourage patients from returning to get routine care and schedule elective procedures with their local hospitals. In turn, that would restrict the volume of clinical laboratory test referrals flowing into the nation’s medical laboratories.
Pathologists and medical laboratory managers should take into account these expert predictions and the supporting data in these two research reports as they plan staffing schedules and consider major purchasing of instruments and test supplies.
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.)
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.
