The latest McKinsey report addresses when the COVID-19 pandemic is “most likely” to end and what needs to happen to get there
Clinical laboratory leaders, pathologists, and diagnostics professionals everywhere want to know when the SARS-CoV-2 coronavirus will burn itself out. When can we expect to return to normal? Since there is no such thing as a crystal ball, it might be helpful to review the latest report from international management consulting firm McKinsey and Company, titled, appropriately, “When Will the COVID-19 Pandemic End?”
It’s a good question, and McKinsey is not certain of the answer. Barring other factors, McKinsey predicts “Transition toward normalcy in the United States remains most likely in the second quarter of 2021 and herd immunity in the third and fourth quarters, but the emergence of new strains and a slow start to vaccine rollout raise real risks to both timelines.” The report also states, “the emergence of more-infectious variants of SARS-CoV-2 increases the risk that this milestone will not be achieved until later.
“More-infectious viruses,” McKinsey continued, “require that a higher percentage of people be simultaneously immune to reach herd immunity. While a more infectious variant likely means more people are acquiring natural immunity through infection (despite ongoing efforts to minimize new cases), the net impact of more-infectious strains is likely to be that a higher portion of the population needs to be vaccinated, which may take more time.”
Challenges That May Slow Herd Immunity to COVID-19
“It is now harder to imagine the United States or United Kingdom transitioning to normalcy before second quarter 2021 or reaching herd immunity before third quarter 2021,” McKinsey added. “Herd immunity to a pathogen is achieved when a sufficient portion of a population is simultaneously immune to prevent sustained transmission.”
But problems in [COVID-19] vaccine distribution, supply shortages, and intermittent participation by the population could push the pandemic endpoint to 2022, cautioned McKinsey.
“We believe herd immunity in the United States is still most likely in third or fourth quarter 2021, but that the chance of delay until first quarter 2022 or beyond has increased,” the report states, “Even later herd immunity remains possible if other challenges arise, especially vaccine safety concerns or ambivalence to vaccination following a transition toward normalcy.”
Other factors that went into the firm’s “most likely” set of possible timelines include:
“Unexpected safety issues emerging with early vaccines,
“Significant manufacturing or supply-chain delays,
“Continued slow adoption,
“Further mutation [of the virus],
“A shorter-than-anticipated duration of vaccine-conferred immunity.”
The graph above, taken from the McKinsey and Co. report, illustrates how “the probability of reaching COVID-19 herd immunity in the United States is highest in the third or fourth quarter, but could shift.” (Graphic copyright: McKinsey and Company.)
A ‘Transition Toward Normalcy’
In its report, McKinsey notes that “During this transition, controlling the spread of SARS-CoV-2 will still require public-health measures (such as continued COVID-19 testing and mask use in many settings), but mortality will fall significantly, allowing greater normalization of business and social activities.”
In apparent agreement, according to data from the COVID Tracking Project, as of Jan. 27, 2021, 107,444 people were hospitalized in the US with COVID-19, as compared to 130,000 hospital cases on Jan. 13, 2021. Numbers of new cases appear to be dropping, however, McKinsey predicts that “COVID-19 will not disappear during this transition but will become a more normal part of the baseline disease burden in society (like flu, for example), rather than a special threat requiring exceptional societal response.”
It may help that more people are taking one of the vaccines. A recent survey conducted by London-based research and analytics firm YouGov, found that people worldwide are becoming more willing to take the COVID-19 vaccine. For example, in the UK, 80% of those surveyed gave a thumbs-up to getting vaccinated, compared to 61% in November. In the US, however, still only about 45% said they will get the vaccine, up slightly from 42% who said so in July, YouGov reported.
However, McKinsey points out that “vaccine rollout has not yet proceeded far enough to protect much of the population.”
How Should Medical Laboratories and Other Healthcare Providers Proceed?
In “No One Said it Would Be Easy,” Jan. 22, 2021, Becker’s Hospital Review, Michael Dowling, President and CEO of Northwell Health, wrote, “We will be living in a world preoccupied by COVID-19 and vaccination for many months to come … And the stark reality is that the vaccination rollout will continue well into the summer, if not longer, while at the same time we continue to care for hundreds of thousands of Americans sickened by the virus. Despite the challenges we face now and in the coming months in treating the disease and vaccinating a US population of 330 million, none of us should doubt that we will prevail.”
“To achieve that,” McKinsey notes, “we will need to see significant progress on the epidemiological end point … Favorable findings on natural and cross-immunity would help accelerate timelines.
“Five additional criteria will also contribute to the transition to a form of normalcy—the more of these that are achieved, the faster the milestone is likely to be reached:
“Continued improvement by governments in the application of public-health interventions (such as test and trace) that don’t significantly limit economic and social activities.
“Compliance with public-health measures until we achieve herd immunity.
“Accurate, widely available, rapid testing that effectively enables specific activities.
“Continued advancements in therapeutics (including pre- and post-exposure prophylactics) for and clinical management of COVID-19, leading to lower infection-fatality ratios—substantial progress has already been made through a combination of effective drugs, such as Dexamethasone and Remdesivir, and changes in clinical management.
“Public confidence that there aren’t significant long-term health consequences for those who recover from COVID-19.”
Finally, McKinsey notes that “Both the epidemiological and normalcy ends to the COVID-19 pandemic are important. The transition to the next normal will mark an important social and economic milestone, and herd immunity will be a more definitive end to the pandemic. In the United States, while the transition to normal might be accomplished sooner, the epidemiological end point looks most likely to be reached in the second half of 2021.”
It is not clear when clinical laboratories and pathologists will know for certain when the pandemic’s end point has been reached. Predictions coming from sources such as McKinsey’s latest report may be as close as we get to a crystal ball view of the pandemic’s future.
Payers are unwilling to reimburse for autopsies despite the fact that autopsies are a proven way to learn more about new diseases and how they attack the human body
Each year, less money is spent by Medicare and private health insurers on autopsies. However, autopsies regularly provide pathologists with relevant, clinically useful information about exact causes of death and other elements of disease in the deceased. Some diseases cannot be identified any other way but by autopsy. And data from autopsies have helped developers bring critical new medical laboratory tests, therapeutic drugs, and vaccines to market.
Thus, the healthcare system is losing valuable research that would bring a better understanding of diseases and processes in the body that contribute to poor health and death. This is true with COVID-19. Autopsy results have already provided revelations into how the SARS-CoV-2 coronavirus affects the body, and yielded clues that are helping pathologists combat the illness.
“Many lives have been saved by looking closely at someone’s death,” he added.
Autopsies performed on deceased patients could help clarify why there is such a wide array of symptoms for those affected by COVID-19 and provide details that cannot be detected in living patients.
For example, autopsies completed early in the pandemic confirmed that the SARS-CoV-2 coronavirus causes respiratory disease, and that extended use of ventilators could cause considerable damage to the lungs, the AP article noted. This discovery led physicians to re-evaluate how ventilators should be used on COVID-19 patients.
The AP story also stated that pathologists learned the SARS-CoV-2 coronavirus may spread the illness to other organs such as the heart, brain, liver, kidneys, and colon.
Through autopsies, COVID-19 patients also were discovered to have dramatic blood clotting issues in almost every organ of the body and micro-clotting in the lungs.
“The clotting was not only in the large vessels but also in the smaller vessels,” said Amy Rapkiewicz, MD, an anatomic and forensic pathologist, Chair of the Department of Pathology at NYU Langone Medical Center and Associate Professor, Department of Pathology at NYU Long Island School of Medicine, in an Advisory Board Daily Briefing. “And this was dramatic, because though we might have expected it in the lungs, we found it in almost every organ that we looked at in our autopsy study.”
Doctors are now exploring whether blood thinners should be utilized to prevent blood clots from forming in COVID-19 patients.
“When you’re able to see what’s happening at the level of the cells, you just have a broader picture of the potential mechanism by which the disease is happening,” Amy Rapkiewicz, MD (above), Chair of the Department of Pathology at NYU Langone Medical Center and Associate Professor, Department of Pathology at NYU Long Island School of Medicine, told Undark. (Photo copyright: Associated Press.)
Autopsies Identify Secondary Causes of Death
Autopsies also have shown that some COVID-19 patients are dying from secondary bacterial infections that appear alongside the disease. This discovery may help doctors understand lingering symptoms that plague some coronavirus patients.
“What you see at autopsy represents an effective catalogue of the injury that occurs in patients who have COVID,” pathologist Stephen Hewitt, MD, PhD, associate research physician, Laboratory of Pathology, and head of the Experimental Pathology Laboratory at the National Cancer Institute Center for Cancer Research, told Undark. “And it gives you an understanding and a basis to try and forecast forward what we’re going to see in post-COVID syndrome.”
Shortage in Funding and Forensic Pathologists
With advances in technology, clinical laboratory testing, and imaging scans, autopsies are performed much less than they were in the past. In the 1950s, autopsies were performed on about half of the patients who passed away in hospital situations, but now that number is somewhere between only five and 11%, ABC News reported.
At this time, hospitals are not required to provide autopsy services and the costs to perform autopsies are often not covered by private or government insurance.
“As medicine has become closer to the bottom line, community hospitals don’t want to perform the autopsies because they’re not getting any functional reimbursement for them,” Hewitt told Undark.
Hospitals usually have to cover costs associated with autopsies themselves or pass those expenditures along to the deceased patient’s family. Autopsies typically cost anywhere from $1,000 to $5,000 per patient, Undark reported.
“When you consider there’s no reimbursement for this, it’s almost an altruistic practice,” Billie Fyfe-Kirschner, MD, a pathologist with Rutgers University, told the Associated Press. “It’s vitally important, but we don’t have to fund it.”
According to the AP, the US faces a critical shortage of forensic pathologists who are trained to perform autopsies. It is estimated, AP reported, that “the US has only a few hundred forensic pathologists but could use several thousand—and less than one in 100 graduating medical school students enters the profession each year.”
Clearly, pathologists have much to offer in the field of autopsies. Autopsying patients who died from COVID-19 may provide data that could greatly affect treatment for those diagnosed with the disease and improve patient outcomes overall.
Pathologists may be interested to learn that though a substitute for horseshoe crab blood has been available for nearly 20 years, it has not been widely adopted in the US
Since the 1970s, the blue blood of the horseshoe crab has saved countless human lives by detecting deadly toxins in medical products, as well as its use in a number of medical laboratory tests. Now, that unique blood is playing a vital role in the fight against COVID-19 as well, by enabling pharma companies to ensure the coronavirus vaccines they are giving are free of bacterial contaminants—such as endotoxins—that can harm or kill patients.
Microbiologists and clinical laboratory scientists are familiar with the Endotoxin Activity Assay (EAA), which uses LAL as a way to detect if a critically-ill patient may have whole blood endotoxemia. Published studies show that the detection of elevated endotoxin activity levels is associated with an increased disease severity in patients with sepsis and septic shock.
Horseshoe crab blood is an opaque blue color due to its high copper content. The blood contains limulus amebocyte lysate or LAL (pronounced “el-ay-el”), which either clots or changes color in the presence of bacterial endotoxins. LAL has become the standard to test the safety of many medical devices and pharmaceuticals—including coronavirus vaccines. There are currently no other tests that can analyze the purity of medications and cleanliness of medical devices with the same accuracy as the LAL test.
“The crabs live only on the east coasts of Asia and North America,” Yahoo News reported. “The world’s largest population of American horseshoes winters off Maryland shores and spawns each spring in Delaware Bay. The latest trawl survey puts this population at more than 14 million mature crabs.”
Futuristic Clean Rooms for Extracting Blood
After the crabs are dredged from the ocean floor, or captured as they come ashore for breeding, they are transported to one of a handful of facilities authorized to perform the bleeding process. Once there, the horseshoe crabs are cleaned and sterilized, suspended upside down, and inserted with a needle which extracts approximately one third of their blood.
“These things are being produced in ‘clean rooms’ that look like the stuff they make microchips in,” Glenn Gauvry, Founder and President of the Ecological Research and Development Group Inc. (ERDG) told Yahoo News. ERDG is a 501(c)3 non-profit wildlife conservation organization. Its primary focus is the conservation of the world’s four horseshoe crab species.
In futuristic-looking labs (above), technicians withdraw the prized blood cells from the tubular heart of the crab and then spin the blood in a centrifuge to isolate the LAL. The resulting product is then sold as endotoxin test kits to pharmaceutical companies that test medical and clinical laboratory supplies, including COVID-19 vaccines. (Photo copyright: Popular Mechanics.)
Certain laboratory tests developed from horseshoe crab blood are used to detect bacterial contamination in everything from heart stents, saline drips, and flu shots, to surgical implants such as pacemakers and prosthetic devices.
Federal law mandates that any medical device that is inserted or injected into a human body must pass the LAL test for contamination. This makes horseshoe crab blood vital for ensuring the new COVID-19 vaccinations are free of potentially-deadly toxins.
“Without LAL, you’re not going to be able to produce the billions of inoculations that are going to have to come about to handle this pandemic,” John Tanacredi, PhD, Professor of Earth and Environmental Sciences, Department of Biology, Chemistry and Environmental Studies at Molloy College, told CBS News.
A $60 Million/Year Industry
Once the LAL has been withdrawn, the crabs are returned to the wild. The horseshoe crabs typically spend one to three days in the lab while the LAL is extracted. They can survive out of water for up to four days, as long as their gills stay moist.
The crabs are then returned to the fishermen who originally caught them, to be gently placed back into the sea. “We treat these crabs like babies,” Yahoo News reported one fisherman saying. “Blue bloods save lives,” said another fisherman.
The Atlantic States Marine Fisheries Commission estimates that in 2019 labs extracted blood from approximately 640,000 horseshoe crabs in the US. Researchers estimate the industry makes about $60 million per year and that the coveted blue blood is worth about $60,000 per gallon, Yahoo News reported.
There are only four labs in the US authorized to extract blood from the horseshoe crabs. They are located in Maryland, Virginia, South Carolina, and Cape Cod. In Maryland, only three trawlers hold permits to catch the horseshoe crabs from the waters surrounding that state.
“We have a 450 million-year-old creature that for the last 45 years has improved the safety of medicines for humans and animals,” John Dubczak, Director of Operations at Charles River Laboratories, told CBS News.
Allen Burgenson, Global Subject Matter Expert-Testing Solutions, Lonza Walkersville, a division of Lonza Bioscience, told Yahoo News “the [pharmaceutical] industry produces enough tests in one day to screen five billion doses of coronavirus vaccine.”
Synthetic Substitute for Horseshoe Crab Blood Available, But Not Widely Used in US
In response to pressure from conservation groups, researchers in Singapore successfully cloned the blood of horseshoe crabs and developed a synthetic test for endotoxins. The synthetic test, known as Recombinant Factor C (rFC), has been commercially available since 2003 and in some countries in Europe is accepted as equal to tests using horseshoe crab blood. However, rFC has not yet been approved for widespread use in the US.
“You’ve got a very large, biomedical bleeding industry with a vested interest in keeping those horseshoes crabs coming in and basically protecting this monopoly,” Ryan Phelan, co-founder and Executive Director of Revive and Restore, a wildlife conservation group based in California that lobbied for the synthetic, told Yahoo News.
In 2017, Dark Daily reported on the potential threat to horseshoe crabs due to blood harvesting. In “Medical Laboratories Could Be Threatening the Survival of Horseshoe Crabs,” we noted growing concerns that the biomedical industry was having a negative impact on the horseshoe crab population. Since then, not much movement has been made toward establishing the synthetic as the standard test in the US.
Recombinant Factor C might eventually eliminate the need to harvest blood from living creatures. But for now, horseshoe crabs continue to provide a critical component for safeguarding humans against contaminants in medical supplies and pharmaceuticals, including COVID-19 vaccinations.
According to Dubczak, the LAL test “has unequivocally elevated the quality and safety of injectable pharmaceutical drugs and medical devices, and that includes all of the vaccines that protect us,” he told USA Today.
Walmart may be the largest, but it is not the only retailer offering clinical laboratory testing and primary care services at conveniently-located retail stores
Earlier this month in “How Walmart Plans to Take Over Health Care,” CNBC asked, “Is Walmart the future of healthcare?” Good question. In the midst of the COVID-19 pandemic, Walmart (NYSE:WMT) managed to open six Walmart Health locations in Georgia and Arkansas. In addition, the giant retailer announced plans to open more primary care clinics at Walmart Supercenters in Chicago and Florida.
Clinical laboratory managers who struggle to keep revenues flowing should take notice. These retail clinics may not have their own medical laboratories, but their primary care physicians will be generating lab specimens.
And because Walmart offers medical laboratory tests at these locations, with so many people opting to visit health clinics installed within retail stores, independent clinical labs could see a noticeable drop in business as Walmart Health expands its network across the US.
Therefore, clinical labs near Walmart Health locations would be wise to develop strategies and services toward becoming a lab test provider to these retail clinics.
Walmart Health Eyes Florida Primary Care Market
“The past few months in particular have exposed the vulnerabilities of our healthcare system and left many without access to adequate health resources,” said Lori Flees, Senior Vice President and Chief Operating Officer, Walmart US Health and Wellness, in a blog post. “We know our customers need us more than ever, which is why we’re announcing an expansion of Walmart Health.
“We’re planning to open seven Walmart Health locations in the Jacksonville [Florida] market in 2021, with at least one opening in early 2021, and we’re beginning conversations in the Orlando and Tampa markets. Our new health centers will be in communities in need of affordable, accessible preventive care, which we will help deliver through Walmart Health,” Flees wrote.
Walmart could be operating 22 Walmart Health locations like that shown above in Georgia, Florida, Arkansas, and Illinois by the end of 2021, Fierce Healthcare reported. This means Walmart Health may double its locations by the end of this year. Clinical laboratories near these locations may want to reach out and offer lab testing services to these retail clinics. Notice that, in the picture of the exterior of a Walmart Health clinic, “Labs” is a service that is prominently displayed as one of the important clinical services offered at that site. (Photo copyright: Walmart.)
Can Clinical Laboratories Compete or Collaborate with Walmart?
A news release announcing the opening of the Walmart Health Centers in Chicago stated that Walmart Health partners with “local, on-the-ground health providers to deliver primary care, labs, x-ray and diagnostics, counseling, dental, and hearing services all in one facility at transparent pricing regardless of a patient’s insurance status.”
However, clinical laboratories wanting to be a testing provider to Walmart Health may have to keep their costs of tests and services down in order to be competitive.
Walmart Health’s “Summary Price List” provides a complete list of medical laboratory tests and services offered at the retail clinics.
Other Primary Care Disruptors
Walmart is not the only retailer offering primary care services amid the COVID-19 pandemic.
Walgreens Boots Alliance (NASDAQ:WBA) partnered with VillageMD, a provider of primary care services, to open 500-700 “Village Medical at Walgreens” primary care clinics “in more than 30 US markets in the next five years, with the intent to build hundreds more thereafter,” according to a news release.
By end of summer 2021, 40 “Village Medical at Walgreens” primary care sites (above) are expected to open in Texas, Arizona, and Florida, according to a January 2021 news release. Walgreens is investing $1 billion over three years in the clinics, which will be situated near its stores. “Through these conveniently located clinics at our neighborhood stores, we will uniquely integrate the pharmacist as a critical member of VillageMD’s multi-disciplinary care team to provide patients with personalized and coordinated care,” said Stefano Pessina, Walgreens Executive Vice Chairman and CEO, in the news release. (Photo copyright: Walgreens Boots Alliance.)
Clinical laboratory managers and pathologists will want to be on the alert for opportunities to forge relationships with Walmart Health, Walgreens, and CVS Health to capture new primary care-related testing business coming out of these non-traditional healthcare providers.
The key to success with pooled testing, says the lab’s director, is having the right personnel and equipment, and an LIS that supports the added steps
Experts believe pooled testing for COVID-19 could reduce the number of standard tests for SARS-CoV-2 by conserving testing resources and cutting lab spending on tests and testing supplies. However, some clinical laboratories have found pooled testing causes inefficiencies due to the lab’s lack of staff, limitations of existing equipment, and biosafety hood space, as well as not having a laboratory information system (LIS) that can manage the large volume of specimens and retesting involved in pooled testing.
One such example is the microbiology lab at 562-bed University of Vermont Medical Center (UVMC) in Burlington, Vt. After evaluating the pooled-testing method, Christina M. Wojewoda, MD, pathologist, Director of Clinical Microbiology at UVMC and an Associate Professor at the Larner College of Medicine at University of Vermont, decided last summer not to do pooled testing, due to the manual steps that the process requires.
The manual steps include having clinical laboratory scientists work under protective hoods to limit the virus’ spread, and both hood space and med techs are in short supply at UVMC, she explained during an exclusive interview with The Dark Report, Dark Daily’s sister publication.
“Our evaluation then is the same as it is now,” she commented. “The barriers to pooling still hold true. Instead of pooling, we keep up with the volume of COVID-19 samples by balancing in-house SARS-CoV-2 testing and send-out testing.”
Low Viral Load a Problem in Pooled Testing for SARS-CoV-2
Another problem, Wojewoda added, is when one patient’s sample in a pool of specimens has a low viral load of SARS-CoV-2. Clinical labs in some states have found that when the prevalence of the novel coronavirus in the population is below 5%, then pooled testing could be an effective testing strategy. However, although Vermont has a relatively low presence of the COVID-19 virus in the population, Wojewoda remains concerned about the viral load in a pooled sample.
“For us, it is less of an issue with prevalence in the population than an issue with low viral load in one patient sample, and that can happen with any prevalence level,” she said. “If there is a low level of virus in one sample, and that sample is combined with samples from four other patients to create the pool, you could dilute the virus below the assay’s level of detection. That means you could miss low-level positive patients.
“When we first considered pooling, we worried about missing those patients, but since then we’ve learned more about the SARS-CoV-2 virus,” she continued. “Now, we now know that patients start producing high levels of virus quickly and that low virus levels often occur toward the end of their infection, after they’ve probably been tested or identified.
“That means we’re less concerned with low levels of virus now than we were initially, at least when pooling five specimens in one tube. But it’s still something to watch for,” she noted.
What About Too Much Virus?
The opposite of this problem also is a concern. If the incidence of infection is too high in a population, then pooled testing could produce too many positive results. The required retesting then makes the process inefficient.
Wojewoda has heard similar concerns from her colleagues at other medical laboratories. They said they were not doing pooled SARS-CoV-2 testing for some of the same reasons.
“When we looked into pooled testing, a number of complications made it impractical,” she said. “Instead, we have been testing each patient individually.”
When patient COVID-19 samples exceed 500 in a day, UVMC sends those specimens to the Broad Institute in Cambridge, Mass., for testing.
During the summer, the rate of COVID-19 infections in Vermont was at about 1%, Wojewoda noted. In the last week of December, the Vermont Department of Health reported the seven-day average percentage of positive tests was 2.2%.
Laboratory Information System Challenges When Doing Pooled Testing
In addition to her concerns about the level of detection, UVMC’s laboratory information system (LIS) was another worry. “Clinical laboratories are designed to test one sample and get one result, and that one result goes into one patient’s chart,” she explained. “But when the lab makes a pool of, say, five patients’ samples, those five results need to go into five patients’ charts.
Wojewoda estimates that manual data entry for each of those results takes a solid minute per sample. “That’s not a lot, but it adds up over time, and it’s not something we do normally.”
Normally, lab test results get filed automatically into the patient’s chart, and then those results are available to patients online, she noted.
“There may be multiple fixes for this problem of accurately and efficiently getting pooled test results into the LIS, then reported to each individual patient, but for us the current state of our computer system requires that we enter each result into each patient’s chart manually. We try not to do that as much as possible because of the potential for errors from manual entry,” she said.
When Automation Falls Short
In addition, Wojewoda said that pooled testing cannot be automated the way most standard clinical laboratory tests are run.
“With routine testing, we put a sample on the instrument and let the test run,” she explained. “When we get the result, it goes into the patient’s chart. But, for pooled testing, we have to collect five samples and then pause to manually put a little bit of each of those five samples into one tube. Then, we put that tube on the instrument.
“After we get the results, we manually report the negative results into each patient’s chart,” she continued. “But if they’re positive, then lab staff must find the five tubes and test each one individually. Therefore, we’re doubling the time it normally takes to produce and report a positive result for SARS-CoV-2.”
Any positive results in a pooled sample, she explained, are held up at the instrument so that the lab staff can pull those five samples from the pool and test each one individually. “Then those individual results go into each patient’s chart, because potentially only one of the five might be positive. We don’t want all five of those patients to be labeled as positive if only one is positive,” she added.
Pooled testing for COVID-19 adds a layer of complexity that the UVMC lab does not normally do, noted the lab’s Director Christina M. Wojewoda, MD (above), a pathologist and Director of Clinical Microbiology at the University of Vermont Medical Center (UVMC) in Burlington, in an interview with The Dark Report. She added that the lab’s staff is already stretched thin and doing as much as possible. “In all these ways, pooled testing is different from how we usually run clinical lab tests. It’s clear that the idea behind pooled testing is to improve efficiency, and yet the need for manual data entry and pulling pooled samples apart create inefficiencies,” she commented. (Photo copyright: University of Vermont.)
Shortage of Lab Techs and Hood Space Compound Inefficiencies of Pooled Testing
Another problem is the requirement to pipette each specimen, she noted. “All infectious samples require hood space and a lab technician to do the work under the hood. But both hood space and lab techs are in short supply.”
Wojewoda explained that some tests being run at the UVMC lab are not being tested from the primary tube.
“There’s often a step where we take some of the primary sample and put it into a tube or cartridge for the test. Then, we put multiple samples together, and we have to pipette each one into the tube without cross contaminating the other samples,” she explained.
“At the same time, we have to track the five patient samples so that we can find the original specimen for testing if we need to do so later. All those steps take more staff time.
“So, while pooled testing saves reagents, it also takes more staff time for pipetting and data entry and the need to record which samples are in which tubes,” she noted. “That might require a spreadsheet or other electronic means to track which samples come from which patients.
“An automated way to do the pipetting would be helpful and would increase staff safety,” she added. “I worry when we’re working with something as infectious as SARS-CoV-2, because the lab techs must dig swabs out of liquid media before discarding them, while being careful not to contaminate anything around them.”
Pooled testing for COVID-19 clearly has potential. But, as Wojewoda explained, it brings complications that can cause inefficiencies. Clinical laboratory managers will want to evaluate existing instrumentation, automation, staffing, and laboratory informatics capabilities to determine if and how their labs would experience similar inefficiencies before a final decision to begin a program of pooled testing for COVID-19.
