Its low cost may advance liquid biopsy cancer testing used by anatomic pathologists and improve outcomes by speeding time to diagnosis and treatment
Researchers in Japan say they have created a circulating tumor cell (CTC) detection solution that is inexpensive and easy to run. Such a device would be of huge interest to investors and companies wishing to develop clinical laboratory tests that use circulating tumor cells in the blood to identify patients with cancer.
In a proof-of-concept study, researchers at Kumamoto University (KU) in Japan have developed and tested a microfilter device they claim can separate and capture CTCs in blood without large equipment, a KU news release reported.
According to Medgadget, the device is an “inexpensive, convenient, and highly sensitive filter that can successfully work in samples containing as few as five tumor cells in one milliliter of blood and does not require expensive equipment or reagents, unlike certain pre-existing cell capture technologies.”
This Technology Could Give Pathologists a Less-Invasive Cancer Test
As medical laboratory scientists and anatomic pathologists know, a CTC test is less invasive than tissue biopsy, which benefits patients. Furthermore, such a CTC test may enable earlier detection of cancer and start of treatment improving odds for success.
Still, there are many pitfalls to overcome when the challenge is to detect cancer cells in a milliliter (about .03 fluid ounce) of blood. As Medgadget put it, “A needle in a haystack doesn’t even come close.”
“Cancer cell count in the blood of cancer patients is extremely low. If these cells are easily detectable, cancer diagnosis may be possible by simply using a blood test, thus reducing patient burden,” the researchers wrote in their paper.
“This work demonstrates that our microfilter device can accurately detect trace amounts of cancer cells in blood,” said study leader Yuta Nakashima, PhD (above), Associate Professor, Department of Mechanical System Engineering at Kumamoto University, in the news release. “We expect it will be adopted for cancer diagnosis and treatment, including for early diagnosis of cancers that cannot be detected by imaging like CT and PET scans, post-operative follow-up, recurrence monitoring, and tailor-made treatments. In the future, we plan to use blood samples donated by cancer patients to verify the practical and clinical application of the method,” he added. Were it to become available, such a CTC test would be a boon for clinical laboratories and anatomic pathologists engaged in cancer diagnostics and treatment. (Photo copyright: Kumamoto University.)
How Does the CTC Filter Device Work?
The KU scientists created a palm-size “cancer detection device using a microfilter and nucleic acid aptamer,” the paper said, adding:
It includes slits to enable a deformation with force of blood pumping through the device.
As blood flows over the microfilter, cancer cells bind to the nucleic acid aptamer.
Force of blood flow opens microfilter slits, pushing away the healthy cells.
Cancer cells are left on the microfilter.
To test the microfilter the researchers used one milliliter of blood that was “spiked with cancer cells,” according to the paper. Findings include:
Detection of five CTCs in one milliliter of blood.
Blood cell removal rate of 98% suggested “no blood cells were absorbed by the microfilter,” the news release said.
The method “showed higher accuracy than the CellSearch System,” the Talanta paper noted.
The KU research team compared their microfluidic device to CellSearch, an FDA-cleared system for detecting CTCs from a blood sample.
CellSearch enables “identification, isolation, and enumeration of CTCs of epithelial origin,” according to Menarini Silicon Biosystems of Castel Maggiore, Italy. It works from a blood sample of 7.5 millimeters with “high level of sensitivity and specificity,” notes the company’s website.
According to Menarini, labs offering CellSearch CTC testing include:
The UK scientists admit that their research needs further study. Nakashima indicated he plans to test blood samples donated by cancer patients in subsequent device trials.
“Although great progress has been made, there is a long way to go before CTC-based liquid biopsy is widely used as a routine test in clinical application,” the authors of that study noted.
Nevertheless, even with more to do, liquid biopsy testing has come a long way, as multiple Dark Daily eBriefs reported over the years.
If the KU scientists succeed in bringing to market a microfilter that can reduce the cost of CTC detection by clinical laboratories while also improving cancer diagnostics, that will have a huge impact on cancer patients and is worthy of clinical laboratory leaders’ attention.
Group’s report also suggests that at-home clinical laboratory tests for COVID-19 that are difficult to use may lead to inaccurate results
At-home clinical laboratory tests for COVID-19 have become quite popular. But how accurate are they? Now, an independent safety organization has investigated COVID-19 rapid antigen tests to find out how easy—or not—they are to use and what that means for the accuracy of the tests’ results.
ECRI (Emergency Care Research Institute) of Plymouth Meeting, Penn., “conducted a usability evaluation to determine if there were any differences in ease of use for the rapid COVID-19 tests,” according to the company’s website.The nonprofit was founded in the 1960s by surgeon and inventor Joel J. Nobel to evaluate medical devices that have been approved by the U.S. Food and Drug Administration (FDA).
“Because of the urgency in providing useful information to consumers as quickly as possible, ECRI selected the seven test kits based on retail availability,” ECRI noted.
ECRI ranked the seven over-the-counter (OTC) at-home rapid antigen tests according to their SUS usability ratings. The System Usability Scale (SUS), invented by John Brooke in 1986, “rates products on a scale of 0 to 100 with 100 being the easiest to use. More than 30 points separated the top and bottom tests analyzed,” according to Managed Healthcare Executive.
Of the seven rapid antigen test kits for COVID-19, ECRI found “noteworthy usability concerns” and “significant differences in ease of use.” None of the tests achieved a SUS rating of “excellent,” ECRI stated in a press release.
“Our evaluation shows that some rapid [COVID-19] tests are much easier to use than others. If given options, consumers should choose tests that are the easiest to use because when a [COVID-19] test is difficult for a consumer to use, it may lead to an inaccurate result,” said ECRI President and CEO Marcus Schabacker, MD, PhD, in a news release. Marcus “is a board-certified anesthesiologist and intensive care specialist with more than 35 years of healthcare experience in complex global environments, and more than 20 years of senior leadership responsibilities serving the medical device and pharmaceutical industries across the healthcare value chain,” states ECRI. (Photo copyright: Biz Journals.)
Seven Rapid Antigen Tests for SARS-CoV-2 Evaluated
As clinical laboratory scientists and pathologists know, it’s possible for different test methodologies for the same biomarker to produce dissimilar results. Another factor affecting medical laboratory test accuracy is the variability from one manufacturing batch or lot to another. And, as the ECRI report suggests, how a specimen is collected and handled can affect accuracy, reliability, and reproducibility of the test results generated by that specimen.
These are the OTC COVID-19 rapid antigen tests ECRI evaluated and their SUS ratings:
Some tests, the ECRI analysts found, required “fine motor control” or were packed with written instructions ECRI determined were too small for older adults to read.
How ECRI Evaluated the COVID-19 Rapid Antigen Tests
SUS reviewers took each rapid test and completed questionnaires specifying their level of agreement (on a range of one to five) with these statements. (Edited by Dark Daily for space):
Desire to use
Perception of unnecessary complexity
Easy to use
Support of a technical person needed
Functions well-integrated
Too much system inconsistency
Easy to learn for most people
A very cumbersome system to use
Feeling of confidence in use
A need to learn before getting going
ECRI then used an algorithm to derive an aggregate score (from 0 to 100) for each test, the report noted.
“Based on the aggregate SUS scores, none of the COVID-19 test kits would be judged to have ‘excellent’ usability. The On/Go, CareStart, Flowflex test kits we rate as ‘very good’ as the usability score for these kits falls just short of ‘excellent,’” the report said.
Some of the positive responses ECRI received from the SUS participants included:
“One of the simpler tests to use with good, printed instructions,” (On/Go and CareStart).
“Cassette makes handling without touching test strip easy,” (CareStart and Flowflex).
“The QR (quick-response) code-linked instructional video is helpful, but probably not needed,” (QuickVue).
“Once the swab is inserted into the test card, the test seems less likely to be spilled or disturbed than other test kits,” (BinaxNOW).
Is it Time for Rapid COVID-19 Antigen Tests?
Unlike RT-PCR tests that can take hours or days to return results, rapid antigen tests provide a quick result that’s used for screening worldwide. And with the COVID-19 Omicron variant spreading rapidly around the world, speed is much needed, according to Stephen Kissler, PhD, Research Fellow in the department of immunology and infectious diseases at Harvard’s T.H. Chan School of Public Health.
“I think the rapid tests provide some of the best protection we have against the spread of disease, especially as we now have a variant on hand that’s going to be able to cause an awful lot of breakthrough infections,” Kissler told The Atlantic-Journal Constitution.
One way clinical laboratory leaders can help is to reach out in their local markets and provide information on the importance of appropriate sampling and collection for accurate results from rapid COVID-19 antigen testing.
Study conducted on International Space Station found crew’s red blood cells were destroyed 54% faster in space than while on Earth
Hemolysis in blood specimens is something that clinical laboratories deal with every day. Now researchers in Canada have determined that, while astronauts are in space, hemolysis is a causative factor in the condition known as “space anemia.”
Hematologists whose clinical laboratories process a steady volume of complete blood count (CBC) tests to diagnosis anemia will want to take note of this research study, which was conducted at the University of Ottawa and on the International Space Station. Dubbed the “MARROW” study, it may have uncovered not only why astronauts suffer from anemia even a year after returning to Earth, but also how those insights can be applied to treatments for anemia and other blood diseases for Earthbound patients as well.
Anemia is caused by a marked decrease in the number of red blood cells and can lead to weakness, persistent fatigue, and slower brain function, which on Earth is concerning, but in space can be life threatening.
“Space anemia has consistently been reported when astronauts returned to Earth since the first space missions, but we didn’t know why,” said the study’s lead author Guy Trudel, MD, in a University of Ottawa news release.
Trudel is Director of the Bone and Joint Research Laboratory at the Ottawa Hospital Rehabilitation Centre in Canada. He is also a Rehabilitation Physician and Researcher at the Ottawa Hospital and Professor of Medicine at the University of Ottawa, and the principal investigator of the MARROW study, which is investigating the effects of microgravity on bone marrow, according to NASA.
“Our study shows that upon arriving in space, more red blood cells are destroyed, and this continues for the entire duration of the astronaut’s mission,” he added.
Although these scientific findings may not immediately lead to new methodologies for testing human blood for use in clinical laboratories, the insights gleaned from the study could inform future studies designed to learn how to get the body to produce more red blood cells in ways that benefit patients diagnosed with anemia or other blood disorders.
Guy Trudel, MD (above), Rehabilitation Physician and Researcher at the Ottawa Hospital and Professor at the University of Ottawa, is lead author of a Canadian study explaining why astronauts develop “space anemia.” In space, astronauts’ red blood cells are destroyed 54% faster than while on Earth, a finding that could have implications for space tourists and astronauts on longer missions to the moon and Mars, the researchers noted. (Photo copyright: University of Ottawa.)
Effects of Anemia Continue One Year after Returning to Earth
The MARROW research project, which was funded by the Canadian Space Agency (CSA), required the participation of 14 astronauts on the International Space Station.
The researchers began collecting data in October 2015 and completed their final tests in June 2020. They found that astronauts’ bodies destroyed 54% more red blood cells in space than would be normal on Earth, according to the study published in Nature Medicine.
“Thankfully, having fewer red blood cells in space isn’t a problem when your body is weightless,” Trudel said in the news release. “But when landing on Earth, and potentially on other planets or moons, anemia affecting your energy, endurance, and strength can threaten mission objectives. The effects of anemia are felt once you land and must deal with gravity again.”
The MARROW experiment detected the following changes:
During a six-month mission, astronauts’ bodies were destroying 54% more red blood cells than typical preflight rates.
Five of the 13 astronauts who had their blood drawn shortly after landing back on Earth were anemic. Red blood cell levels gradually improved three to four months post-flight.
The rate of red blood cell destruction remained 30% higher one year after landing than before missions to the International Space Station.
“Increased hemolysis as a primary effect of exposure to space constitutes a paradigm shift in our understanding of space anemia … Persistent hemolysis during space missions suggests that the longer the exposure, the worse the anemia,” the study’s authors wrote.
Measurements were made by testing the astronauts’ blood for iron levels and using breath tests to measure exhaled carbon monoxide. One molecule of carbon monoxide is produced every time one molecule of heme, the deep-red pigment in blood cells, is destroyed.
According to the researchers, the discovery that space travel increases red blood cell destruction:
highlights the need to screen astronauts and space tourists for existing blood or health conditions that are affected by anemia;
impacts longer missions to the moon and Mars, which would likely worsen an astronaut’s anemia;
suggests astronauts require an adapted diet; and
shows it is unclear how long the body can maintain this higher rate of destruction and production of red blood cells.
Space Study Could Lead to Better Healthcare on Earth
A 2007 NASA study published in Microgravity Science and Technology blamed space anemia on water loss during space flight decreasing the amount of hemoglobin in red blood cells. The study labeled space anemia a “15-day ailment” because those researchers believed issues resolved within 15 days of crew members returning to Earth.
The MARROW study, however, found much longer-lasting implications for astronauts in space, which could lead to new insights for patients on Earth. The Canadian Space Agency believes the study’s findings could lead to better understanding and monitoring of the effects of physical inactivity on seniors, bedridden patients, and those with reduced mobility or undergoing rehabilitation.
“The findings have implications for understanding the physiological consequences of space flight and anemia in patients on the ground,” Sulekha Anand, PhD, a professor in the Department of Biological Sciences at San Jose State University, told Reuters.
This latest study shows how discoveries in space continue to lead to advancements in scientists’ understanding of how the human body functions. That knowledge may one day provide the foundation for developing new or improved clinical laboratory tests for astronauts as well as everyday earthlings.
Scientists working to sequence all 1.66 million animal species say this is a missed opportunity to better understand our own genetics; such research would identify biomarkers useful for clinical laboratory testing
For 23 years, the world’s genomic scientists have been on a mission to sequence the genomes of all animal species. And they’ve made great progress. However, according to a recent study conducted by researchers at Washington State University (WSU) and Brigham Young University (BYU), only a fraction of the sequences are from invertebrate species. And that, according to the study’s authors, is “overlooking huge swathes of diversity and opportunity.”
The push to sequence the whole genomes of all animals began in 1998 with the sequencing of the Caenorhabditis elegans roundworm, according to a WSU news release. It was the first animal genome sequence, but it was not to be the last. Nearly 25 years later, genomic scientists have sequenced about 3,300 animal genomes. And while that’s a lot of genomic sequences, it’s a drop in bucket of the approximately 1.7 million animal species on the planet.
But here’s where the missed opportunity comes in. According to the WSU news release, “Vertebrates account for 54% of all genome sequencing assemblies, despite representing only 3.9% of animal species. In contrast, the invertebrates of the Arthropoda phylum, which includes insects and spiders, comprise only 34% of current datasets while representing 78.5% of all species.”
“We are interested in ourselves, and that’s not necessarily a bad thing,” said Paul Frandsen, PhD (above), in the news release. Frandsen is Assistant Professor of Genetics, Genomics, and Biotechnology at Brigham Young University and one of the study authors. “But to begin to understand entire ecosystems,” he continued, “we have to start sampling more of the variety of life to gain a clearer picture. Vertebrates are important components of ecosystems, but arguably insects and many other small creatures probably play an even more important role because they’re down at the base of the food web.” (Photo copyright: Brigham Young University.)
The scientists analyzed the best available genome assemblies found in GenBank, the world’s most extensive genetic database. They found that 3,278 unique animal species across 24 phyla, 64 classes, and 258 orders have been sequenced and assembled to date.
They also found that sequencing efforts have focused heavily on species that most resemble humans. The Hominidae, a taxonomic family of primates that includes humans as well as great apes, bonobos, chimpanzees, orangutans, and gorillas, has the most contiguous genome data assembled.
The team discovered that vertebrates account for 54% of the animal genome sequencing that has been performed even though they make up less than four percent of known animal species. By comparison, invertebrates of the Arthropoda phylum, which represent 78.5% of all animal species, comprise only 34% of the completed animal genome sequencing. And yet, the Arthropoda phylum is the largest phylum in the animal kingdom and includes insects, spiders, scorpions, centipedes, millipedes, crabs, crayfish, lobsters, and barnacles.
“With genome assemblies accumulating rapidly, we want to think about where we are putting our efforts. It’s not being spread evenly across the animal tree of life,” said lead author Scott Hotaling, PhD, post-doctoral researcher at WSU, in the news release. “Invertebrates are still very underrepresented, which makes sense given that people seem to care more about vertebrates, the so-called ‘charismatic megafauna.’”
The team discovered that only five arthropod groups: ants, bees, butterflies, fruit flies, and mosquitos, were well represented in genome sequencing. The longest genome sequenced so far belongs to the Australian lungfish, the only surviving member of the family Neoceratodontidae.
1,100 Years to Sequence All Eukaryotic Life
The scientists also discerned that animal genome assemblies have been produced by 52 countries on every continent with permanent inhabitants. The majority of animal genome sequencing (77%) that is being performed is mostly occurring in developed countries located in the Northern Hemisphere, often referred to as the Global North. Nearly 70% of all animal genome assemblies have been produced by just three countries: the United States, China, and Switzerland.
There are geographic differences between regions regarding the types of animals being sequenced and assembled with North America concentrating on mammals and insects, Europe focusing on fish, and birds being the main type of animals sequenced in Asia.
The scientists would like to see more animal genome sequencing happening in countries from the Global South, or Southern Hemisphere, particularly in tropical regions that contain a myriad of diversity among animal species.
“If we want to build a global discipline, we need to include a global people,” Hotaling said. “It’s just basic equity, and from a pure scientific standpoint, the people who live in areas where species are being sequenced have a lot of knowledge about those species and ecosystems. They have a lot to contribute.”
But the WSU/BYU scientists found that many species in GenBank only have low-quality assemblies available. They noted that “the quality of a genome assembly is likely the most important factor dictating its long-term value.”
Fortunately, several animal genome sequencing ventures have been announced in recent years, so the amount of available data is expected to rise exponentially. These projects include:
The Earth BioGenome Project (EBP) which aspires to sequence and catalog the genes of all the eukaryotic species on the planet within ten years.
The Vertebrate Genomes Project which seeks to generate high-quality assemblies for 70,000 extant vertebrate species.
The Bird 10K Project that seeks to generate assemblies for all extant birds.
The i5K Project which plans to produce 5,000 arthropod genome assemblies.
The authors of the PNAS paper noted that there are currently only about four genome assemblies happening each day and, at that rate, the sequencing of all eukaryotic life will not be completed until the year 3130.
So, microbiologists, clinical laboratory professionals, and genomic scientists have plenty of time to get up to speed.
Given the large number of mutations found in the SARS-CoV-2 Omicron variant, experts in South Africa speculate it likely evolved in someone with a compromised immune system
As the SARS-CoV-2 Omicron variant spreads around the United States and the rest of the world, infectious disease experts in South Africa have been investigating how the variant developed so many mutations. One hypothesis is that it evolved over time in the body of an immunosuppressed person, such as a cancer patient, transplant recipient, or someone with uncontrolled human immunodeficiency virus infection (HIV).
One interesting facet in the story of how the Omicron variant was being tracked as it emerged in South Africa is the role of several medical laboratories in the country that reported genetic sequences associated with Omicron. This allowed researchers in South Africa to more quickly identify the growing range of mutations found in different samples of the Omicron virus.
“Normally your immune system would kick a virus out fairly quickly, if fully functional,” Linda-Gail Bekker, PhD, of the Desmond Tutu Health Foundation (formerly the Desmond Tutu HIV Foundation) in Cape Town, South Africa, told the BBC.
“In someone where immunity is suppressed, then we see virus persisting,” she added. “And it doesn’t just sit around, it replicates. And as it replicates it undergoes potential mutations. And in somebody where immunity is suppressed that virus may be able to continue for many months—mutating as it goes.”
Multiple factors can suppress the immune system, experts say, but some are pointing to HIV as a possible culprit given the likelihood that the variant emerged in sub-Saharan Africa, which has a high population of people living with HIV.
Li “was among the first to detail extensive coronavirus mutations in an immunosuppressed patient,” the LA Times reported. “Under attack by HIV, their T cells are not providing vital support that the immune system’s B cells need to clear an infection.”
Linda-Gail Bekker, PhD (above), of the Desmond Tutu Health Foundation cautions that these findings should not further stigmatize people living with HIV. “It’s important to stress that people who are on anti-retroviral medication—that does restore their immunity,” she told the BBC. (Photo copyright: Test Positive Aware Network.)
Omicron Spreads Rapidly in the US
Genomics surveillance Data from the CDC’s SARS-CoV-2 Tracking system indicates that on Dec. 11, 2021, Omicron accounted for about 7% of the SARS-CoV-2 variants in circulation, the agency reported. But by Dec. 25, the number had jumped to nearly 60%. The data is based on sequencing of SARS-CoV-2 by the agency as well as commercial clinical laboratories and academic laboratories.
Experts have pointed to several likely factors behind the variant’s high rate of transmission. The biggest factor, NPR reported, appears to be the large number of mutations on the spike protein, which the virus uses to attach to human cells. This gives the virus an advantage in evading the body’s immune system, even in people who have been vaccinated.
“The playing field for the virus right now is quite different than it was in the early days,” Joshua Schiffer, MD, of the Fred Hutchinson Cancer Research Center, told NPR. “The majority of variants we’ve seen to date couldn’t survive in this immune environment.”
One study from Norway cited by NPR suggests that Omicron has a shorter incubation period than other variants, which would increase the transmission rate. And researchers have found that it multiplies more rapidly than the Delta variant in the upper respiratory tract, which could facilitate spread when people exhale.
Using Genomics Testing to Determine How Omicron Evolved
But how did the Omicron variant accumulate so many mutations? In a story for The Atlantic, virologist Jesse Bloom, PhD, Professor, Basic Sciences Division, at the Fred Hutchinson Cancer Research Center in Seattle, described Omicron as “a huge jump in evolution,” one that researchers expected to happen “over the span of four or five years.”
Hence the speculation that it evolved in an immunosuppressed person, perhaps due to HIV, though that’s not the only theory. Another is “that the virus infected animals of some kind, acquired lots of mutations as it spread among them, and then jumped back to people—a phenomenon known as reverse zoonosis,” New Scientist reported.
Still, experts are pointing to emergence in someone with a weakened immune system as the most likely cause. One of them, the L.A. Times reported, is Tulio de Oliveira, PhD, Affiliate Professor in the Department of Global Health at the University of Washington. Oliveira leads the Centre for Epidemic Response and Innovation at Stellenbosch University in South Africa, as well as the nation’s Network for Genomic Surveillance.
The Network for Genomic Surveillance, he told The New Yorker, consists of multiple facilities around the country. Team members noticed what he described as a “small uptick” in COVID cases in Gauteng, so on Nov. 19 they decided to step up genomic surveillance in the province. One private clinical laboratory in the network submitted “six genomes of a very mutated virus,” he said. “And, when we looked at the genomes, we got quite worried because they discovered a failure of one of the probes in the PCR testing.”
Looking at national data, the scientists saw that the same failure was on the rise in PCR (Polymerase chain reaction) tests, prompting a request for samples from other medical laboratories. “We got over a hundred samples from over thirty clinics in Gauteng, and we started genotyping, and we analyzed the mutation of the virus,” he told The New Yorker. “We linked all the data with the PCR dropout, the increase of cases in South Africa and of the positivity rate, and then we began to see it might be a very suddenly emerging variant.”
Oliveira’s team first reported the emergence of the new variant to the World Health Organization, on Nov. 24. Two days later, the WHO issued a statement that named the newly classified Omicron variant (B.1.1.529) a “SARS-CoV-2 Variant of Concern.”
Microbiologists and clinical laboratory specialists in the US should keep close watch on Omicron research coming out of South Africa. Fortunately, scientists today have tools to understand the genetic makeup of viruses that did not exist at the time of SARS 2003, Swine flu 2008/9, MERS 2013.
Due to the national health system’s aggressive cost-cutting measures over the past 20 years, some regions of the island country now have only limited local medical laboratory services
It was in the early 2000s when different district health boards throughout New Zealand decided on a strategy of issuing sole source, multi-year medical laboratory testing contracts in their regions to cut lab test testing costs. Consequently, pathology laboratories that lost their bidding were forced to cease operations or merge with the winning bidders. At the time, New Zealand pathologists and laboratory scientists feared the government health system was undermining the financial stability of pathology laboratories and leaving portions of the country with limited testing capacity.
Now, arrival of the SARS-CoV-2 Omicron variant on the remote island nation may be creating a day of reckoning for that decision. In particular, “holiday hotspots” in New Zealand may be filling up with seasonal travelers at the exact moment a surge in COVID-19 testing is needed.
Holiday Destinations Lack Pathology Lab Capacity
Medical laboratory scientist Terry Taylor, president of the New Zealand Institute of Medical Laboratory Science (NZIMLS), fears some small-town tourist destinations do not have the local-based medical laboratory testing capacity to process a surge in PCR tests and will need to ship samples elsewhere, delaying the speed at which COVID-19 test results can be delivered in communities that attract thousands of vacationers during New Zealand’s summer from December to February.
“In these areas, those swabs that are taken will end up being sent to the mothership so to speak, so one of the larger laboratories that’s nearby those regions,” he told Checkpoint. “So, there will be delays when this starts to kick on.”
Taylor also pointed out that shifting lab work to larger medical centers creates capacity concerns within those facilities as well.
“I will reiterate, all of the big hospitals will obviously still be operating 24-hour services doing the acute work that’s coming through,” he said. “But be aware, we do everything. We don’t just do COVID testing, so sometimes things are just going to have to wait in those periods.”
“We’ve certainly got to get together now and come up with a plan that works so that we do not inundate our laboratories and therefore the other health services,” medical laboratory scientist Terry Taylor (above), president of the New Zealand Institute of Medical Laboratory Science, told Newshub. “It is really not an option to test everyone. We need to be looking at who we test, how we test and when we test,” he added. (Photo copyright: Newshub.)
In a statement to Checkpoint, the New Zealand Ministry of Health maintained COVID-19 testing remained a priority for the government over the Christmas and New Year period.
“The ministry works closely with DHBs (District Health Boards) and laboratories to manage demands for testing, and to reiterate the importance of processing and returning tests as quickly as possible,” the statement said. “It should be noted that samples of close contacts of cases and high-risk individual are prioritized by laboratories.”
Dark Daily Correctly Predicted Pathology Lab Losses
In 2009, Dark Daily reported on New Zealand’s use of contract bidding for pathology lab testing services in Wellington and Auckland in an effort to drive down costs. The winning labs agreed to roughly a 20% decrease in reimbursement rates.
At that time, Editor Robert L. Michel predicted the loss of established pathology providers and insufficient reimbursement rates could lead to scaled down testing menus, loss of skilled staff and a negative impact on patient care. He noted then, “New Zealand may become the first developed country in the world to learn what happens to the entire healthcare system when deep budget cuts finally leave medical laboratories with insufficient reimbursement.
“Such a situation,” Michel continued, “would likely mean that laboratory test providers in New Zealand would lack the funding and resources to offer physicians and patients a full menu of state-of-the-art diagnostics tests. It could also mean that medical laboratories would lack adequate resources and skilled staff to sustain the quality of test results at a world-class level of quality, accuracy, reliability, and reproducibility. In either case, the quality of patient care would be negatively affected.”
Fast forward to 2022, as the COVID-19 pandemic continues some New Zealand leaders fear the opening of Auckland’s border to summer travelers will lead to community spread of the coronavirus at a time when budget cuts have left these same regions with local pathology testing capacity that is insufficient to meet the needs of the surrounding community.
In fact, New Zealand’s first case of community exposure to the Omicron variant was reported in Auckland on December 29, 2021, a Ministry of Health news release noted.
“You’re going to see the virus seeded everywhere,” epidemiologist Michael Baker, Professor of Public Health, University of Otago in Dunedin, New Zealand, told The Guardian in mid-November.
Critical Supply Shortages as Pathology Testing ‘Crunch Point’ Reached
In the early months of the COVID-19 pandemic, New Zealand’s clinical laboratory system nearly reached a breaking point as a shortage of COVID-19 tests left the system teetering on the edge of collapse.
According to Joshua Freeman, MD, Clinical Director of Microbiology and Virology at the Canterbury DHB, the “crunch point” arrived around March 20, 2020, when New Zealanders were being urged to get tested so the country could determine if there was community transmission of the virus, online news site Stuff reported.
Meanwhile, testing supplies such as reagents, plastic tubes, and pipette tips were in short supply globally and 13 regional labs were yet to be set up across the country. Even once the new laboratories, district health board testing centers, and mobile clinics were up and running, procuring needed supplies remained challenging, according to COVID-19 testing data from the Ministry of Health.
America also Struggled with COVID-19 Supply Shortages
While New Zealand’s mostly publicly funded universal healthcare system has been stressed by the COVID-19 pandemic, America’s private system has not fared much better. In the early months of the pandemic, personal protective equipment, COVID-19 tests, and testing materials also were in short supply in this country.
CBS News reported that the US was continuing to struggle with limited supplies of COVID-19 rapid antigen tests and long turnaround times for clinical laboratory polymerase chain reaction (PCR) tests as families gathered for the recent holiday season.
Thus, clinical laboratory leaders and laboratory scientists in this country should watch with keen interest at how New Zealand’s pathology laboratories fare as the Omicron variant further challenges the country’s testing capacity.
