Following criticism over delays in authorizing medical LDT COVID-19 tests, the FDA swiftly shut down consumer at-home specimen collection schemes
Banning COVID-19 tests that
rely on consumers’ collecting their own specimens at home is one example where
the federal US
Food and Drug Administration (FDA) took remarkably swift action. It’s also
interesting to note how some business people—who lack formal training in clinical
laboratory medicine—often are ready to seize any opportunity to sell lab
tests directly to consumers, regardless of whether such tests are reliable,
accurate, medically-necessary, and reasonably priced.
Last month, in the midst of this novel coronavirus
pandemic, the attempt by a handful of direct-to-consumer
(DTC) lab companies to sell COVID-19 tests to customers was speedily stopped by
the FDA less than 10 days after the agency became aware of the DTC testing
schemes. This all happened off the radar screen of most pathologists
and clinical laboratory administrators, whose full-time attention has been on
serving the urgent needs of their parent hospitals, referring physicians, and
patients.
Within days of each other, several direct-to-consumer lab
testing companies announced plans to offer COVID-19 tests to consumers. A
common feature of these offerings was that each DTC company would send a
collection kit to the consumer, who would collect his or her specimen at home.
The kit would then be sent to one of the DTC company’s CLIA-certified
laboratories, where the SARS-CoV-2
(Severe Acute Respiratory Syndrome Coronavirus 2) test would be performed.
A flurry of press releases and news interviews about how
consumers could order and pay for their own COVID-19 test, collect the specimen
at home, and have a Clinical
Laboratory Improvement Amendments (CLIA)-certified lab perform the test
quickly caught the attention of the FDA. Federal officials took immediate
action, or close to it.
On March 20, the FDA issued a warning to healthcare
consumers to beware of “unauthorized fraudulent COVID-19 test kits.” On the
same day, the FDA announced updated
guidance on its website pointing to recent policy adjustments stating
that “testing by CLIA-certified labs that had not yet acquired Emergency Use
Authorization (EUA) for their COVID-19 diagnostic does not apply to at-home
COVID-19 testing, ‘including self-collection of samples to be sent to a
clinical laboratory,’” reported MobiHealthNews.
“We want to alert the American public that, at this time,
the FDA has not authorized any test that is available to purchase for testing
yourself at home for COVID-19,” the FDA said in a
statement. “The FDA sees the public health value in expanding the
availability of COVID-19 testing through safe and accurate tests that may
include home collection, and we are actively working with test developers in
this space.”
Nevertheless, the FDA stipulated that at-home specimen
collection was still not authorized.
Collectively, the FDA’s two actions sent an unmistakable
message to the DTC lab companies that affected their consumer COVID-19 testing
plans. Following public release of the FDA’s recommendation and policy change,
several of the DTC lab companies posted messages on their websites disclosing
that they would not be selling COVID-19 tests with consumer self-collection
after all.
Everlywell Health’s DTC Clinical Laboratory Test Plan
News stories about the plans of these companies contained
details that pathologists and clinical laboratory managers will find
interesting. That is certainly true of Everlywell,
a DTC lab company with a distinctive background.
Austin-based Everlywell was founded in 2015 by Julia Cheek. She
appeared on the Shark
Tank television program in 2017 and received $1 million in funding for her
business plan, which Dark
Daily covered. Cheek’s plan was to sell selected medical laboratory
tests directly to consumers, including placing collection kits in retail stores
and pharmacies. in the same year, investors pumped another $4 million into Everlywell,
for a total of $5 million in venture capital funding, reported Business
Wire.
“The extreme shortage of tests for COVID-19 puts millions of Americans at risk,” said Julia Cheek (above), Founder and CEO of Everlywell, in a March 18, 2020, press release. She added, “Everlywell is committed to helping stop the spread of COVID-19 in the US by making this test widely available. As the national leader in at-home lab testing, we want to use our resources and expertise to help as many people as we can. We are committed to this fight, and we’re here to help.” A few days later, the FDA reiterated its ban on at-home COVID-19 specimen collection. (Photo copyright: Forbes/Whitney Martin.)
Everlywell, which manufactures laboratory test kits for
everything from general wellness and energy/weight, to men’s health, women’s
health, and sexual health, was among several companies that just days before
the FDA’s warning had announced plans for an at-home COVID-19 lab test with telehealth diagnosis.
Before the FDA banned at-home testing, Everlywell had an
initial supply of 30,000 collection kits and planned to work with “multiple
labs to scale infrastructure,” with a goal of testing 250,000 people weekly, stated
a company news
release. In news interviews, Everlywell said these consumer-collected
specimens would be done by CLIA-certified clinical laboratories. However, the
company did not name the lab companies it expected to use to perform those
tests.
Everlywell’s at-home test carried a $135 price tag for
consumers, an amount the company noted was “at-cost.” Before purchasing a
COVID-19 test, consumers are required to complete an eligibility questionnaire
developed in accordance with CDC recommendations. Testing includes a free telehealth
consultation with a board-certified physician for consumers who tested
positive.
However, after the FDA issued its March 20 warning, Everlywell
announced on its
website that its COVID-19 test would not be available for individual
purchase.
“Our frontline healthcare workers are in desperate need of
testing,” the site states. “We have made the decision to allocate today’s test
supply to hospitals and healthcare providers only.”
Everlywell was asked to comment on these matters by Dark Daily’s sister publication, The Dark Report. As of this date, the company has not responded to that request.
Other DTC Companies Suspend Plans to Sell At-Home
COVID-19 Test Kits
The Wall
Street Journal (WSJ) reported that Scanwell Health, Nurx Inc.,
and Curative Inc. also were among the handful of companies that curtailed plans
to launch at-home COVID-19 testing following the FDA’s announcement.
Scanwell Health now plans to wait for FDA clearance under
the EUA for its at-home COVID-19 blood test.
Though the US is making strides to increase testing, lack of
testing capacity has hamstrung the nation’s healthcare system as it attempts to
control the COVID-19 pandemic.
An at-home test would appear to be one option for increasing
COVID-19 testing nationwide. However, the FDA is signaling to these
direct-to-consumer lab testing companies—along with clinical laboratories—that
specimen quality issues associated with consumers collecting their own samples
carry the risk of producing inaccurate test results.
This is something that pathologists and medical laboratory
professionals understand because the largest source of errors in clinical
laboratory testing come from the pre-analytical stage. This is the part of the
testing process where a specimen is collected, then transported to a laboratory
and prepared for analysis at the bench.
Previously considered “junk,” scientists learn that parts of DNA which don’t produce proteins are more important than first thought
It turns out that the long stretches of DNA in the human genome that are commonly called “junk DNA” or “dark DNA” may be doing important work. Researchers at the Ontario Institute for Cancer Research (OICR) recently published their findings about stretches of junk DNA that may have a role in how cancers develop.
Until very recently only about 2% of the human genome was considered important. Researchers were most interested in the portion of DNA that produces proteins, known as the coding region or CDS (coding sequence). The rest of the genome, 98% of it, was considered “junk” DNA. The OICR researchers found that all that DNA might not be junk after all, but instead plays a critical role in preventing cancer.
The OICR study included samples from more than 1,800 patients
with different types of cancer. The researchers looked at more than 100,000
sections of each patient’s genome and examined mutation patterns within the
large, non-coding parts of DNA. The researchers found that those non-coding
areas can control how and when certain genes are activated.
“One of the 30 key regions discovered was predicted to have a significant role in regulating a known anti-tumor gene in cancer cells, despite being more than 250,000 base pairs away from the gene in the genome,” states the news release.
Viewing DNA in New Ways Brings Insights
Within just the last few years, researchers have begun to
consider the architecture of DNA, and have begun to study it as a three-dimensional
(3D) structure. What they’ve learned is that the twisting, turning way that DNA
is packaged tightly into the nucleus of cells serves an important purpose. The
structure of DNA allows areas of non-coding DNA to be in close proximity to
other sections, as the OICR researchers discovered with the anti-tumor gene.
This discovery has revealed patterns that weren’t obvious
when the DNA was examined as if it were stretched out in a flat line. Before
scientists considered DNA in three dimensions, they were only able to identify certain
mutations, such as BRCA,
which are rare but indicate a higher cancer risk.
In looking at DNA as a whole, including the non-coding parts, researchers were able to identify specific Single Nucleotide Polymorphisms (SNPs) that when in particular positions can impact a person’s risk of cancer.
“Cancer-driver mutations are relatively rare in these large non-coding regions that often lie far from genes, presenting major challenges for systematic data analysis,” noted Jüri Reimand, PhD (above), molecular geneticist and principal investigator at OICR, Assistant Professor at the University of Toronto, and lead author of the OICR study. “Powered by novel statistical tools and whole genome sequencing data from more than 1,800 patients, we found evidence of new molecular mechanisms that may cause cancer and give rise to more-aggressive tumors.” (Photo copyright: University of Toronto.)
Another study conducted by scientist in England at Cancer Research UK and published in the British Journal of Cancer (BJC), titled, “Nongenic Cancer-Risk SNPs Affect Oncogenes, Tumour-Suppressor Genes, and Immune Function,” reached similar conclusions. The authors of that study wrote that “cancer-risk SNPs are associated with the expression levels of oncogenes [a gene with the potential to cause cancer] and tumor suppressor genes at a far greater rate than expected by chance. This indicates not only that mutations in these cancer genes are important, but also that genetic control of these genes by regulatory variants plays an important role.”
CRISPR and AI Bring New Discoveries
All of these genetic discoveries are a long way from being useful in developing diagnostics and treatments that can be used to help patients. However, researchers are using existing gene sequencing technologies such as CRISPR, along with artificial intelligence (AI), to speed up development.
The OICR researchers used CRISPR-Cas9 genome editing to explore the cancer-driving area of DNA they identified. And the researchers who conducted the BJC study plan to develop AI models based on their work that will better predict cancer risk.
“What we found surprised us, as it had never been reported before. Our results show that small genetic variations work collectively to subtly shift the activity of genes that drive cancer. We hope that this approach could one day save lives by helping to identify people at risk of cancer as well as other complex diseases,” said John Quackenbush, PhD, Professor, Computational Biology and Chair, Department of Biostatistics, Harvard T.H. Chan School of Public Health and lead author of the Cancer Research UK study, in a news release.
Clinical pathology may be on the cusp of change, driven in
large part by the discoveries being made in the realms of omics. New cancer
biomarkers coming out of these studies would be a boon to anatomic pathologists
and clinical laboratory diagnostics. Increased development of precision
medicine treatments based on these research findings could save many lives.
Two major clinical laboratory conferences reschedule, as the SARS-CoV-2 pandemic continues to disrupt long-planned events; Many labs are losing money as fewer patients visit physicians
This week, the ongoing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pandemic was responsible for two important developments in the clinical laboratory industry. Both involved the rescheduling of major annual conferences. In both cases, conference organizers are placing different bets on when they think the COVID-19 outbreak, the illness caused by the SARS-CoV-2 coronavirus, will have passed and when they believe some semblance of normalcy will return to both social interaction and business activities.
On Monday, the American Association of Clinical Chemistry (AACC) announced that it would reschedule its 2020 AACC annual meeting and exhibition—originally scheduled for July 26-30, 2020, at McCormick Place in Chicago—to Dec. 13-17, 2020, also at McCormick Place.
On the same day, Dark Daily’s sister publication, The Dark Report, announced it had rescheduled the 25th annual Executive War College on Laboratory and Pathology Management to new dates and to a new hotel. This conference will now take place on July 14-15, 2020, at the Hyatt Regency Hotel in New Orleans. This is a change from the originally scheduled date of April 28-29, 2020, and from the original location, the Sheraton New Orleans Hotel.
On its website, AACC stated: “Based on input from all stakeholder groups, and in close collaboration with host city officials, the organization is pleased to announce that AACC will be able to preserve the complete Annual Scientific Meeting and Clinical Lab Expo experience to which its members, exhibitors, and the entire laboratory medicine community have been looking forward. The 2020 AACC Annual Scientific Meeting and Clinical Lab Expo will now be held December 13-17, 2020, at McCormick Place in Chicago, IL, USA.”
Each conference claims to be “the largest” in some
dimension. Each year, AACC’s annual conference attracts more than 20,000
attendees, as measured by clinical chemists and other visitors to its Expo,
which features more than 750 lab companies.
While the Executive War College claims to be the largest conference serving the business, management, operations, and financial health needs of clinical laboratories and pathology groups. Each year, it hosts almost 900 attendees—generally senior administrators, lab executives, pathologist-business leaders, consultants, and in vitro diagnostics (IVD) manufacturers. The conference is supported by more than 50 corporate benefactors and sponsors.
AACC’s rescheduling of its conference from July to December
will delay two important activities:
Many lab scientists planning to attend were hoping to participate in the first assessments of the novel coronavirus pandemic, assuming that the pandemic had passed by mid-summer.
During AACC is when the nation’s major IVD manufacturers and companies that sell lab automation, instruments, test kits, reagents, and other products introduce their latest-generation solutions. Now, many of those product launches will be pushed back to December.
Meanwhile, organizers of the Executive War College are betting that the novel coronavirus pandemic will taper down, possibly synchronized with the end of the annual influenza season in North America, which is typically sometime in April or early May.
If this proves true, then conducting the conference on July 14-15, 2020, will give lab leaders the opportunity to gather and share lessons learned during this COVID-19 outbreak in time to prepare for a possible second outbreak of COVID-19 when the next influenza season arrives in the fall. It will also be an important opportunity for lab managers and pathologists to learn ways to restore revenue lost during the pandemic.
Clinical Laboratories, Pathology Groups, Hospitals, at
Brink of Financial Ruin
“What has gone unrecognized by the national news media is how the novel coronavirus pandemic is causing financial devastation to the finances of the nation’s clinical laboratories and anatomic pathology groups,” stated Robert L. Michel, Editor-in-Chief of The Dark Report and Founder of the Executive War College. “In absolute terms, the pandemic is a growing financial disaster to the medical lab industry, and it will take years for many labs to rebuild the staff that they have laid off or terminated in recent months in order to stay operational.
“Why are all labs losing money at this time?” asked Michel.
“The answer is simple—beginning early in March, patients stopped visiting their
doctors. Hospitals ceased to admit patients for elective procedures. Fewer
patients per day means fewer lab test referrals per day and loss of the revenue
generated by those claims that pays the salaries and expenses of the labs
performing those tests. Laying off or furloughing staff is one way labs lower
costs in response to lower income.
“Many clinical labs, pathology groups, and the hospitals
they serve are steadily approaching financial ruin,” he continued. “Every week
the pandemic continues, and North American citizens are advised to shelter in
place, forces labs to draw down their dwindling financial reserves to keep
their doors open.”
Robert Michel (above), Editor-in-Chief of The Dark Report and Dark Daily and Founder of The Dark Intelligence Group, will host the 25th anniversary Executive War College on Lab and Pathology Management on July 14-15, 2020, in New Orleans. Attendees from clinical laboratories and pathology groups will gain critical insights from such learning opportunities as: “Preparing Your Lab for a Second Outbreak of COVID-19,” and “Rapidly Building Cash Flow and Restoring Your Lab’s Financial Stability Post-Pandemic.” (Photo copyright: The Dark Report.)
This crisis has created three big questions that labs need
to answer:
How much longer will the COVID-19 pandemic last
before some degree of normalcy is restored (meaning patient office visits resume
and physicians begin ordering lab tests every day)?
If there is a second outbreak of SARS-CoV-2 this
fall, what does every lab need to know to be ready?
As American society and business return to
normal, how can labs quickly build up cash flow, collect more revenue, and
restore financial stability?
“Given the unknown aspects of the SARS-CoV-2 coronavirus,
the answer to the first question is a crap-shoot. But to reschedule the
Executive War College to dates that are 14 weeks away seems a reasonable bet,”
noted Michel. “The pay-off to that bet is the ability to provide the owners and
leaders of the nation’s labs answers to the second and third questions.
“The 14 weeks between now and mid-July give us the
opportunity to organize sessions and invite speakers who can provide answers
and information to help labs with their two most pressing needs: to be prepared
for another COVID-19 outbreak later this year, and to restore cash flow and
financial health as soon as possible,” said Michel. “This will be the very
first opportunity for lab managers and pathologists to assemble, learn the
COVID-19 lessons from successful labs, gain financial insights, and network
with their peers.”
The Executive War College team is inviting suggestions for
speakers and session topics for the July 14-15 conference. The original agenda
that was taking shape for the planned dates of April 28-29 will be revised so
as to include presentations now directly relevant to the state of the clinical
lab and pathology professions for mid-year 2020. Send your suggestions for
topics and speakers to info@darkreport.com.
Information on registering for the 25th annual Executive War College, and on placing reservations at the Hyatt Regency Hotel in New Orleans, is available on the EWC website (or copy and paste this URL in your browser: https://www.executivewarcollege.com.)
People already registered for Executive War College 2020
will have their registrations automatically applied to the new July 14-15
dates.
Because patient satisfaction continues to drive Medicare scoring, interest grows in technologies that reduce or remove pain from the patient’s experience, particularly when a phlebotomist draws blood for clinical laboratory testing
This is why hospital administrators are devoting more
attention—and budget dollars—to products that have the potential to reduce the
pain experienced by patients. And patient satisfaction surveys regularly
identify pain during phlebotomy procedures as an issue.
Enter PIVO,
a sterile single-use device created by San Francisco-based Velano Vascular Technologies that
attaches to an existing peripheral
intravenous (PIV) line to extract blood samples from patients through the
use of a vacuum tube or syringe, relieving the pain of additional needle
sticks.
Needle-free blood draws is not a new concept. But the fact
that hospitals are adopting such technologies indicates that the need to
improve the patient experience is motivating more hospitals to spend money on
these types of devices.
Velano Vascular’s PIVO device (above) works by pushing a small, flexible flow tube through the IV line and directly into the vein to collect as much blood as needed for medical laboratory testing. After the blood collection has been completed, PIVO is retracted and removed from the IV and discarded. As public demand for pain free healthcare increases, will the practice of phlebotomy in all healthcare settings need to adopt as well? (Photo copyright: HIT Consultant.)
Nurses Approve of No-Stick Technology
The Centura Health system in Centennial, Colo., utilizes
PIVO at all 17 of its hospitals throughout Colorado and western Kansas.
Centura’s goal is to “eliminate some of the suffering that goes along with
needlesticks for inpatients,” Rhonda Ward, MSN,
Vice President Nursing Services and Chief Nursing Officer, South Denver Group, Centura Health, told Modern
Healthcare.
“It adds no pain to the patient,” she said. “Unfortunately,
nurses, just by nature of their work, have to create discomfort in some of the
things that they have to do. So not creating more pain for the patient has been
a big satisfier.”
Velano Vascular first gained
FDA marketing clearance for its proprietary intravenous blood-draw device
in 2015. Later that same year, Intermountain
Healthcare in Salt Lake City became the first healthcare system in the
country to implement the PIVO device. Intermountain now uses PIVO in all 22 of
its hospitals.
“Blood draws are critical, common elements in modern medicine, but they cause an unnecessary amount of anxiety, pain and risk due to the use of century-old technology and practice,” said Kim Henrichsen, MSN, Senior Vice President, Clinical Operations/Chief Nursing Executive, Intermountain Healthcare, in a press release. “We are thrilled to offer a new standard of care that, over time, will help obviate the need for needles used for hospital blood collection. This commitment to standardizing draws will enhance quality for both patients and practitioners.”
According to the Velano website, there are 400 million
inpatient blood draws in the US each year, with each patient receiving 10 to 20
needlesticks per hospital stay. The site also states there are more than 1,000
practitioner needlestick injuries per day in the US and that approximately one
in five people in the country are needle phobic. The company claims the
advantages of the PIVO device include reducing patient pain and anxiety, making
blood draws easier for Difficult Venous Access (DVA) patients, and making the
blood extraction process safer for practitioners.
“It is baffling that in an era of smartphones and space
travel, clinicians draw blood by penetrating a vein with a needle—oftentimes in
the early morning hours,” said Todd
Dunn, Director of Innovation at Intermountain Healthcare Transformation Lab
in the Intermountain press release. “Through our Design for People program, we
resolved to find a better way for our phlebotomists and nurses to more humanely
and consistently draw blood. Following 15,000 PIVO draws on adults and children
with no adverse events and overwhelmingly positive feedback from patients and
caregivers alike, it is clear that we are together establishing a new standard
of care.”
According to a
survey commission by Velano Vascular and conducted by Charter Oak Research of more than 6,500
nurses from 24 hospitals regarding the blood collection process:
Eight out of ten nurses are concerned about
needle safety.
One in three patients are considered tough
sticks.
88% of the nurses felt that blood collection
sticks and re-sticks negatively impact the patient experience.
76% of the nurses would prefer to use needle-free
blood draws over venipuncture.
84% of the nurses said they would advocate for a
needle-free blood draw device.
One of the key findings in the survey found that there is a
lack of standardization in blood collection, and that there is “significant variability
in who and how blood is collected across patient floors and time of day.”
“Commercial demand for PIVO and our family of novel solutions is being driven by a move to one-stick hospitalization and a growing realization that removing needles from blood draws improves the patient experience, protects practitioners, and boosts the bottom line,” Eric Stone, Chief Executive Officer and co-founder, Velano Vascular, told FierceBiotech.
More Research versus Patient Outcomes
Though there are peer-reviewed studies and white papers
outlining positive patient outcomes surrounding the use of the PIVO device,
some professionals feel more research on the product is needed.
“All of these studies would suggest that additional study
would be warranted,” Diane Robertson,
Director Health Technology Assessment and ECRIgene Information Services at the ECRI Institute, told Modern Healthcare.
“But while the evidence is inconclusive at this point on a number of the
potential benefits, in studies and in our look at safety information, there’s
been no indication that there’s been any harm from this technology. It’s
reasonable for hospitals to consider it. It goes back to weighing the
patient-oriented outcomes.”
The need to improve the patient experience and improve
patient satisfaction scores is motivating hospital administrators to spend
money and resources on products like the PIVO device. Clinical laboratory
leaders should be aware of the rate of adoption of such products by healthcare
systems.
Continued growth in products that can collect medical
laboratory specimens without a traditional venipuncture performed by a
phlebotomist could give innovative labs a new way to add value in patient care
in both inpatient and outpatient settings.
Bioeasy stands behind the accuracy of its coronavirus test kits and, in a statement, questioned whether they were being used correctly
How accurate are the SARS-CoV-2 test kits being offered by different in vitro diagnostics companies, as well as the internally-developed COVID-19 tests developed by individual medical laboratories, both here in the United States and in other countries? It’s a question that has not been addressed by the news media nor by healthcare regulators.
That
is why a recent news story reported complaints by authorities in several
European countries that COVID-19 tests they had purchased were “unreliable.”
The source of the COVID-19 test kits was a Chinese company.
On Wednesday, government officials in China announced that manufacturers of test kits for SARS-CoV-2, the novel coronavirus that causes the COVID-19 illness, can no longer export their tests unless China’s National Medical Products Administration (NMPA) has licensed and registered those tests, the South China Morning Post (SCMP) reported.
China issued the new rules after receiving complaints from buyers in Europe about the quality and accuracy of tests kits and other products, including personal protective equipment (PPE), ventilators, and infrared thermometers, SCMP wrote. Previously, Chinese exporters were required only to have CE certification to indicate that their goods conformed to the health and safety standards required for sale in the European Economic Area, SCMP added.
In a joint statement issued March 31, China’s Ministry of Commerce, General Administration of Customs (GAC), and the National Medical Products Administration said the new rule applies to all companies seeking to export test kits, face masks, protective clothing, ventilators, and infrared thermometers.
Spain
Discontinues Use of Rapid Diagnostic Tests from Bioeasy
The new rules came after health authorities in Spain stopped using a rapid diagnostic test (RDT) kit that required a nasopharyngeal (NP) swab to collect specimens to diagnose patients for the SARS-CoV-2 virus, saying the test kits from Shenzhen Bioeasy Biotechnology were unreliable. Turkey also rejected the Shenzen Bioeasy test kits after finding similar problems, according to The Middle East Eye. Ukraine and Georgia also bought kits from Bioeasy, according to published reports.
The low accuracy rate of the Bioeasy coronavirus test kits raises questions about the rapid rate of development for new tests in the United States and worldwide, said Michael Noble, MD, FRCPC, Chair of the University of British Columbia (UBC) Clinical Microbiology Proficiency Testing program and the UBC Program Office for Laboratory Quality Management, in Vancouver.
“There’s
an inherent problem with building a test during a crisis,” Noble said in an
interview with Dark Daily. “Clinical laboratory test developers are
being forced into building tests in a hurry, and the highest likelihood is that
they will fail because these tests take a lot of time if the aim is to get them
right.
“When
a company or a lab feels the need to go too fast, it is likely to take
shortcuts,” he added. “And every time a shortcut is taken, an opportunity for
error is created.
“Also,
the federal Food and Drug Administration (FDA) may be going too fast to issue
emergency use authorizations (EUAs). If laboratory test developers and the FDA
go too fast, then both could make mistakes,” Noble noted.
“The lesson for labs in the United States and everywhere is you can’t go too fast and you don’t want to go too slow either,” Michael Noble, MD (above), Chair of the University of British Columbia Clinical Microbiology Proficiency Testing Program, told Dark Daily. “Instead, you need to proceed as quickly as you can, but also take as long as you need to ensure you follow all the steps accurately.” (Photo copyright: The Dark Report.)
Bioeasy
Questions Whether Tests are Being Used Correctly
On
March 27, SCMP reported that Shenzhen Bioeasy would send new kits to
ensure that “patients get the best diagnostics” and to “ensure the test kits’
sensitivity and specificity.” The company also raised questions about whether
the tests were used properly and promised to send a video explaining how those
administering the tests should collect specimens using NP swabs.
“As
it [is a] rapid test kit, following the protocol is very important,” the
company added, according to SCMP.
Last
week, Zhu Hai, a manager at
Shenzen Bioeasy, said reports that the test kits had a low accuracy rate were
untrue, SCMP reported. A more detailed explanation would be given via
official Chinese government channels, he added.
Shenzen
Bioeasy also issued a statement about the tests, saying, “The production export
of our CE products to Spain has been done according [to] regulations. All
Bioeasy COVID-19 rapid test [kits] are officially CE-IVD approved, so we are free
to [export] and sell in [the EU],” SCMP reported.
The company exported 337,000 tests to South Korea and more than 420,000 test kits to at least 10 countries, including Italy, Qatar, and Ukraine, the company added. It had five million such kits under production, the company said.
Spain
Purchased More than Half a Million Bioeasy Test Kits
One
of the first publications to report the inaccuracy problems was El País, a Spanish
language daily newspaper in Madrid.
The
Shenzen Bioeasy tests functioned much like pregnancy tests, the newspaper
wrote. Once the sample is taken, the NP swab is diluted and placed into a
cartridge with a lined test strip showing whether the result is positive,
negative, or invalid. “The tests detect the presence of antigen and the result is obtained in 10
or 15 minutes,” El País wrote.
Based
in part on a claim that the medical laboratory test kits have an 80% accuracy
rate, the government purchased 640,000 kits to screen health workers and the
elderly. If the Chinese tests were of sufficient quality, negative or doubtful
results would require a confirmatory molecular diagnostics test, the
newspaper added.
The
Chinese embassy in Spain also responded, saying on Twitter on March 26 that
the country’s National Medical Products Administration had not approved the
tests, and that they were not included in the medical supplies the Chinese
government sent to Spain, SCMP reported. “The Chinese Ministry of
Commerce offered Spain a list of approved suppliers, in which Shenzhen Bioeasy
Biotechnology was not included,” the embassy added.
After
the low accuracy rates were reported, the Spanish government said it ordered
€432 million (US$468 million) worth of medical supplies from China, 5.5 million
test kits, 550 million face masks, and 950 ventilators, SCMP added. But
none of the kits in this order were from Shenzen Bioeasy, the government said.
SCMP quoted Professor Leo Poon
Lit-man, BSc, MPhil, DPhil, FFPH, an expert in the SARS-CoV-2 coronavirus
who helped design a testing protocol for the COVID-19 illness, and who is a
Professor and Division Head of the Division of Public Health Laboratory
Sciences at The University of Hong Kong. A claim of 80% accuracy
for a test using nasal swabs was perplexing, because such tests are known to be
inaccurate, Poon said. “It would be dangerous if it’s used on a large scale,
since patients who are supposed to be positive might not be detected,” he
added.
Pathologists
and clinical laboratory scientists know there are many reasons why a clinical
laboratory test can be unreliable or inaccurate. For example, during the
production of a batch of tests, one step in the manufacturing process may have
gone awry and that problem was not detected before those tests were shipped to
a medical laboratory.
Unfortunately,
when lab tests are proved to be “unreliable” or inaccurate, the public or the
medical laboratory profession seldom learn the reasons for these problems and
what steps were taken to resolve them.
