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May 2020
PREDICTING ACUTE
RESPIRATORY
DISTRESS
SYNDROME
Clinical
Laboratory %
News
Accuracy of a prototype AI
model for COVID-19
PAGE 6
An AACC Publication | Volume 46, Number 4
A New
Point-of-Care
Testing Menu
COVID-19 Gut
Lab Microbiome
Preparedness Matters
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M AY 2020 CONTENTS 1
www.aacc.org
EDITORIAL STAFF Features
Managing Editor Bill Malone
Senior Editor Genna Rollins 8 Gut Microbiome: Next Frontier of Precision Medicine
Senior Manager, Communications and PR
Christine DeLong
Research advances still a ways from clinical practice
BUSINESS STAFF
Business Communications Specialist
14 What's Next on the Point-of-Care Testing Menu?
Ana Zelada From SARS-CoV-2 to cardiac biomarkers, a steady stream of IVD
innovation shows no signs of letting up
Board of Editors
Chair
Danyel Tacker, PhD, DABCC, FAACC
West Virginia University, Morgantown, W.Va.
Members
Dustin Bunch, PhD, DABCC
Nationwide Children’s Hospital, Columbus, Ohio
Sara Love, PhD, DABCC
Hennepin Healthcare, Minneapolis, Mn.
Mark Marzinke, PhD, DABCC, FAACC
Johns Hopkins University School of Medicine,
Baltimore, Md.
Alison Woodworth, PhD, DABCC, FAACC
University of Kentucky Healthcare, Lexington, Ky.
Melanie L. Yarbrough, PhD, DABCC, DABMM
Washington University School of Medicine,
St. Louis, Mo.
AACC Officers
President Carmen L. Wiley, PhD, DABCC, FAACC
President-Elect David G. Grenache, PhD, DABCC,
MT(ASCP), FAACC
Treasurer Steven Kazmierczak, PhD, DABCC,
FAACC
8
Secretary Anthony A. Killeen, MD, BCh, PhD,
DABCC, FAACC
Past President Dennis J. Dietzen, PhD, DABCC,
FAACC
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Clinical Laboratory News is published monthly (10 times
per year—Jan/Feb., March, April, May, June, July/August,
14
Sept., Oct., Nov., and Dec.) by the American Association
for Clinical Chemistry. 900 Seventh St., NW, Suite
400, Washington, DC 20001. Phone: +1 202.835.8756
or +1 800.892.1400 Fax: +1 202.877.5093. Contents
copyright © 2020 by the American Association for
Clinical Chemistry, Inc., except as noted. Printing in the
U.S.A. POSTMASTER: Send address changes to AACC,
900 Seventh St. NW, Suite 400, Washington, DC 20001.
Design and Production Management Departments In the past decade,
label-free technologies
Cover: Greg Gibson, Chinnapong / Getty Images
02 Federal Insider
04 Bench Matters have advanced into the
06 The Sample era of dip-in-solution
19 Regulatory Roundup sensing probes. The
22 Industry Playbook resulting label-free
24 Ask the Expert immunoassays are
open access, making
The full text of Clinical
Laboratory News can them similar to plate-
be found on EBSCO’s
CINAHL Complete
database and is also
format assays without
@ CLN_AACC searchable via the EBSCO
Discovery Service™
complicated sample
delivery or fluidics.
p24
2 M AY 2 0 2 0
AACC Endorses Verified Innovative Testing
in American Laboratories Act
Federal Insider AACC endorsed the Verified Innovative Testing in American Laboratories (VITAL)
Act, which would clarify the law around laboratory-develop tests (LDT) and
definitively locate LDTs oversight solely within CLIA administered by the Centers for
Medicare and Medicaid Services (CMS). This effort pushes back against other moves
from Congress and the Food and Drug Administration (FDA) to move LDTs further
under FDA’s purview, creating a cumbersome and duplicative regulatory structure.
In a letter to the VITAL Act’s sponsor, Senator Rand Paul, R-Ky., AACC wrote
that it agrees “that the increase in the number and complexity of LDTs may warrant
a fresh assessment of the regulatory and professional oversight for these tests.”
However, while “some adjustments may be necessary,” the association believes CLIA
oversight is sufficient.
“The FDA regulatory structure is designed for medical device manufacturers, not
clinical laboratories. Laboratories occasionally modify FDA-cleared or approved tests
or develop new in-house tests to meet specific clinical needs,” AACC wrote. “To add
FDA requirements to clinical laboratories utilizing these tests will stifle innovation
and hinder patient access to testing, as occurred recently when the FDA became
involved in LDT oversight during the outset of the COVID-19 public health
emergency.” The VITAL Act would prevent such delays in developing needed tests
in the future, the association added.
■ “AACC’s members, as laboratory Public Readiness and Emergency
AACC URGES CORONAVIRUS professionals, are on the front lines Preparedness Act authorizing
TASKFORCE TO BOLSTER LAB combating this disease,” AACC wrote licensed pharmacists to “order
ACCESS TO TESTING SUPPLIES in the letter. “While the capacity and administer” SARS-CoV-2
I n a letter to the administration’s
Coronavirus Task Force, AACC
called on the White House to tackle
for performing COVID-19 testing
has increased significantly in recent
weeks, our ability to perform tests
testing that has been authored by
the Food and Drug Administration
(FDA). The guidance specifically
the critical needs clinical laboratories is still limited. There is a shortage of notes that this can include
face around sample collection, ana- necessary supplies, including sample serology tests.
lytical test components, and personal collection and test components ... According to the HHS guidance,
protective equipment. Unless and until these supply chain pharmacists are “well positioned to
New guidelines released by the issues are resolved, the nation’s labo- aid COVID-19 testing expansion.”
White House call for an exten- ratories will remain stymied in their The guidance also notes that the
sive testing scheme that states are attempts to maximize their testing majority of Americans live close to
expected to rely on to reopen their capacity. At this point, the biggest a retail or independent community-
economies. barrier to testing is not capacity, but based pharmacy.
Guidelines recommend that states access to vital supplies.” Some pharmacies maintain a
first ensure they have the ability The letter encourages the CLIA certificate of waiver that
to quickly set up safe and efficient Coronavirus Task Force to commu- allows them to perform certain tests
screening and testing sites for individ- nicate “directly and regularly” with termed CLIA waived. In the case
uals with symptoms of COVID-19, the clinical laboratory community to of the novel coronavirus, FDA has
the illness caused by SARS-CoV-2. address barriers to testing. said that any test with an emergency
simpson33 / Getty Images
These guidelines also recommend that use authorization (EUA) indicating it
states test syndromic and influenza- ■ is appropriate for point-of-care
like illness-indicated persons for PHARMACISTS MAY ADMINISTER use should be considered CLIA
COVID-19, ensure sentinel surveil- COVID-19 TESTING waived. At CLN press time, these
lance sites are screening for asymp-
tomatic cases, and trace contacts for
all SARS-CoV-2 positive results.
T he Department of Health
and Human Services (HHS)
issued new guidance under the
waived EUAs included the Abbott
ID NOW, Mesa Biotech Accula,
and Cepheid Xpert Xpress.
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4 M AY 2 0 2 0
Lab Preparedness During the
COVID-19 Pandemic
Strategies for curtailing test menus, implementing
social distancing, and supporting staff morale in
response to a surge in testing and staffing shortages
Bench
Matters T he past few months have been a whirlwind of news
about, and activities in response to, the emergence
and spread of the novel coronavirus, SARS-CoV-2. As this
inpatient census, and providing only
the essential testing our patients need.
To consider what testing might be
pandemic unfolds, laboratory personnel are key to the most useful for COVID-19 patients
efforts to halt the virus’s spread and treat patients. we looked at the literature, recom-
The consequences of the pandemic on laboratories are mendations from the Centers for
likely to go beyond those of more familiar emergencies, Disease Control and Prevention,
like floods or hurricanes. In addition to a possibly over- and practice guidelines or useful
whelming surge in patients with COVID-19 illness, we internet tools. Finally, we considered
might experience planned reductions in other patient how our testing menu would change
populations, a changed patient mix to mostly or nearly all along with fluctuations in workforce
COVID-19 patients, supply shortages, and staff shortages availability, with staffing levels at
as team members need to self-quarantine or stay home to 60%, 30%, and 15% of normal.
care for family members. Our tiered plan involves shutting
down one of our two labs—keeping
A GOOD START open the one that already serves
CLSI 36-A:2014, Planning for Laboratory Operations inpatient needs—and operating only
During a Disaster, is an essential document for laboratory our main chemistry analyzer and
emergency preparedness planning during the COVID- immunoanalyzer line. We also will
19 pandemic. Chapter 10, which deals with planning for shut or slow down testing on plat-
pandemic influenza, easily can be adapted to our current forms where turnaround time can
situation. be delayed and will have the option
Jonathan To help prepare for the pandemic, laboratory leaders at of sending to a reference laboratory
Hoyne, PhD, Mayo Clinic in Florida utilized this document to aid us in testing that we would normally
DABCC, adjusting our hurricane crisis plan to the current situation. perform in-house. In the current
FAACC Our plan involves closing outpatient clinics, decreasing crisis, we will prioritize essential
COVID-19 testing, along with
testing we would perform during our
hurricane response.
By focusing our test menu, we’re
able to divert staff to our hospital
laboratory, cover for absences, sup-
plement our phlebotomy teams, and
provide necessary rest to our staff.
To prepare for a limited menu
offering, lab staff should be cross-
trained between benches as much
as possible. Analytes of specific or
increased utility during our current
crisis might be prioritized. In the
extreme, lab staff might be asked to
perform non-laboratory functions, or
to supervise non-laboratory person-
nel assisting in the lab.
ATTENDING TO STAFF
Greg Gibson
We also have to implement social dis-
tancing, maintaining 6 feet between
individuals whenever possible, holding
M AY 2020 5
meetings via conference calls or in he, she, there, and that to minimize high-stress situation rest has to be
rooms large enough to accommo- confusion and inefficiency. programmed into the plan, and we
date all the attendees while keeping A good way to know if a message need to proactively identify all non-
appropriate distance. Staff must has been communicated effectively essential tasks and defer or cease
remind one another, independent is to have the person receiving the them until the emergency ends.
of hierarchical position, to maintain information repeat it back, with the We will remember the events of
safe distancing. Reminders should be person giving the information asking the next weeks and months for the
accepted with a spirit of gratitude questions about points that might rest of our lives. Clinical laboratory
that each team member is looking out be susceptible to misunderstanding. professionals are essential members
for the entire team. Taking the extra time to commu- of the medical community upon
In addition, labs need to establish nicate effectively will pay off with which our society depends. We will
a clear line of authority beyond our the increased efficiency it affords in rise to the occasion and make our-
usual supervisory structures. This way, completing tasks. selves and our country proud. Take
if supervisors and leads are unable An overlooked aspect of emer- care of yourselves and each other.
to work, we still will have a chain of gency planning—addressed in the
authority for centralizing decision- CLSI document—is the emotional Jonathan Hoyne, PhD, DABCC, FAACC,
making and prioritizing tasks. The impact over time that working in is director of clinical chemistry at Mayo
entire lab staff needs to understand an emergency has on employees. Clinic in Jacksonville, Florida.
this structure going into the crisis. Initially, people come together as + E M A I L : Hoyne.Jonathan@mayo.edu
In an ever-changing emergent a team to tackle an overwhelming
situation with daily tasks and the problem. But as time moves on and What measures has your lab taken in
workforce in flux, communicating staff continue to work under stressful response to the COVID-19 pandemic?
effectively becomes more challenging. conditions, ignoring personal needs Join the conversation on the Artery,
We need to speak precisely, avoiding becomes unsustainable. To make it AACC’s online community:
the use of imprecise descriptors like successfully through an extended artery.aacc.org/home
S
6 M AY 2 0 2 0
Alanine Aminotransferase, Hemoglobin Levels 2 of 3
Features in Artificial Intelligence Tool That Most Predict
Severe COVID-19 Outcomes
A prototype artificial intelligence (AI) tool showed that just three inputs had
the most predictive power for discerning which patients with COVID-19, the
illness caused by the novel coronavirus SARS-CoV-2, would likely develop
The Sample acute respiratory distress syndrome (ARDS) (Comput Mater Con 2020;63:537-
51). Based on data from 53 patients treated at two hospitals in China, this
predictive analytics system found that elevations in alanine aminotransferase
(ALT) and hemoglobin, along with patient-reported myalgia predicted risk of
ARDS with up to 80% accuracy.
Surprisingly, many of the clinical features associated with COVID-19 such as
ground glass opacities on chest computed tomography, fever, cough,
lymphopenia, and dyspnea did not distinguish risk of disease progression and
were not highly predictive. Patients’ viral load (cycle threshold) also did not
prove to be predictive.
Moreover, the patients’ ALT and hemoglobin values were only modestly
elevated. The median ALT value at the time of presentation at hospital was
24 U/L (range, 15-40.5 U/L; reference range, 9-50 U/L). The median
hemoglobin level was 13.7 g/dL (range, 12.9-14.4 g/dL, reference range,
12.8-16.5 g/dL). Other features, including sex, temperature, age, and levels of
sodium, potassium, and creatinine, and lymphocyte and white blood cell counts,
added modestly to prediction.
“The model highlights that some pieces of clinical data may be
underappreciated by clinicians,” wrote the investigators in Wenzhou, China, and
in New York City. They added that features don’t have to be causal to be
predictive.
In their feature engineering and statistical analysis, the researchers employed
entropy, which measures how much information a feature encapsulates;
information gain—the amount of information acquired after knowing the value
of the feature; Gini index, a measure of the impurity of a dataset; and Chi-
Squared statistics, indicating how dependent two variables are.
The authors speculated that myalgia “could represent generalized
inflammatory and cytokine response not captured well by other indicators.” The
slightly elevated hemoglobin levels could be linked to smoking, which has been
associated with increased hemoglobin values, or to male sex.
■ adverse cardiovascular events at patient who received genetically
MAJOR GENETIC TESTING-GUIDED 1 year. However, the largest trial to guided treatment compared with
TRIAL FALLS JUST SHORT OF explore the clinical utility of detecting those who received standard therapy.
1-YEAR EVENT END POINT CYP2C19 *2/*3 loss of function allele These outcomes were presented at
T he much-anticipated TAILOR-
PCI trial assessing genetic
testing to guide antiplatelet therapy
carriers prior to starting antiplatelet
therapy showed a 34% reduction in a
composite of major cardiovascular
the virtual American College of
Cardiology/World Congress of
Cardiology meeting
after percutaneous cardiovascular events at year 1. TAILOR-PCI also (20-LB-20309-ACC).
intervention failed to meet its primary found a statistically significant 40% “Although these results fell short
NIAID
end point of a 50% reduction in drop in the total number of events per of the effect size that we predicted,
M AY 2020 7
they nevertheless provide a signal in the standard care arm and 1.9% transaminase (ALT) levels, and
that offers support for the benefit in carriers in the guided-treatment insulin resistance. The NASH liver
of genetically guided therapy,” said group. fat score is based on the presence of
co-principal investigator Naveen metabolic syndrome, type 2 diabetes,
Pereira, MD, professor of medicine ■ and levels of serum insulin, ALT, and
at the Mayo Clinic in Rochester, LITTLE CONCORDANCE AMONG aspartate aminotransferase (AST),
Minnesota. NONINVASIVE METHODS FOR while the Gholam score uses AST
In a post hoc analysis, the IDENTIFYING NASH and a diagnosis of type 2 diabetes.
researchers found a nearly 80%
reduction in the rate of adverse events
in the first 3 months of treatment in
T hree noninvasive methods
for identifying patients
with nonalcoholic steatohepatitis
The investigators identified
NHANES III participants who had
moderate to severe hepatic steatosis,
participants who received genetically (NASH) agree in only 18% of cases, as determined by ultrasound. In all
guided care versus those who received under-scoring the need for better 1,236 subjects were determined
standard care. noninvasive means of recognizing this to have NASH by at least one
Subjects were randomized to condition, according to an abstract noninvasive method, but the three
receive either standard care—75 mg accepted for the Endocrine Society’s methods all identified NASH in just
daily of clopidogrel—or genetic annual meeting (SUN-606). 18% of cases. Two methods agreed in
testing-guided care. Those who were The investigators used data from 20% of cases.
determined through genetic testing the National Health and Nutrition The three methods all identified
to be CYP2C19 *2/*3 carriers (35%) Examination Survey III (NHANES significant risk factors for NASH as
received 90 mg of ticagrelor twice III) to compare three noninvasive being overweight or obese, having
daily; otherwise, participants in methods of identifying NASH: the elevated AST or ALT levels, and
the genetic testing arm of the trial NASH liver fat score, the HAIR having raised C-peptide, serum
received clopidogrel. There were score, and the Gholam score. glucose, or serum triglyceride levels.
1.6% major or minor bleeding events The HAIR score incorporates the However, the methods disagreed on
at the end of 1 year in participants presence of hypertension, alanine the significance of other risk factors.
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8 M AY 2 0 2 0
Gut
Microb
Research advances T
Next Frontier of P
remendous advances in
next-generation
sequencing and omics
“The pendulum has swung from
a focus on killing pathogenic bacte-
ria to a focus on healthy, symbiotic,
still a ways from technologies have
catapulted microbiome science into
an exciting new frontier in medicine.
and commensal microbes,” said
Melissa Melby, PhD, co-director of
the Humans and the Microbiome
clinical practice Emerging data suggest that the
microbiome—the rich ecosystem of
more than 100 trillion bacteria, fungi,
Program at the Canadian Institute
for Advanced Research (CIFAR) in
Toronto. “There has been a shift in
and viruses in and on the human clinical care as well as the popular
BY PRANALI P. PATHARE, PHD
body—is integral in almost all aspects consciousness with the realization
of human health and disease and that that microbes are not all bad.”
analysis of the microbiome one day This deeper appreciation of the
could play an important role in microbiome’s power doesn’t mean
clinical practice. that clinical labs should expect toM AY 2020 9
obiome:
of Precision Medicine
be performing omic analyses of the
microbiome anytime soon, according
to Robert Britton, PhD, professor of
With more than 1 million
genes—versus 23,000 in the human
genome—the abundance and diversity
most promising lines of investigation
involves the gut microbiome. Initially
thought to have a role limited to
molecular virology and microbiol- of the microbiome is staggering; digesting complex carbohydrates and
ogy at Baylor College of Medicine microbiome communities in differ- synthesizing vitamins and nutrients,
in Houston. “I do believe that in five ent body sites have unique profiles, as this microbiome now is understood
to ten years, we’ll see microbiome- does each individual, influenced by to be a structural and functional part
based therapies making it to clinics, diet, medications, and other environ- of the body. Evidence shows that the
but what that’s going to be, who mental factors. gut microbiome globally governs host
knows,” he said. “We now must do physiology by regulating metabolism,
the heavy lifting and find the func- A BURGEONING FIELD immunity, and even the gut-brain axis,
tions behind … associations showing Research into the complex and via signaling of unique microbiome-
microbiotas have positive and dynamic interactions between micro- generated bioactive metabolites.
negative effects on different types of organisms and their human hosts has Disturbances in normal gut micro-
diseases.” taken off in recent years. One of the bial profiles have been associated with10 M AY 2 0 2 0
a range of conditions from cancer to said W.H. Wilson Tang, MD, profes- investigators discovered not only
metabolic, inflammatory, cardiovas- sor of medicine and research director that each person’s blood glucose
cular, and even neurodegenerative of heart failure and transplant at the levels were different even when they
diseases. “Amazing and incredibly Cleveland Clinic Lerner College of consumed the same food as others
large observational studies have Medicine. but also that microbiome rather than
shown very clear associations between “For a successful clinical transi- genetic data correctly predicted each
features of the gut microbiome and tion, we have to go beyond a very person’s blood glucose response to
clinical outcomes,” said Jonathan pathway-specific manner of looking an identical food. Furthermore, the
Peled, MD, PhD, a medical oncologist at things and instead look at how sys- team’s algorithm accurately predicted
at Memorial Sloan Kettering Cancer tems interact,” he explained. His team individual dietary interventions that
Center in New York City. “We and and others have identified metabolites successfully balanced glucose levels in
others have found associations processed by gut microbes that drive pre-diabetic people—outperforming
between perturbations of the gut the progression of several cardiovas- the standard-of-care diet.
microbiome and complications of cular pathologies like atherosclerosis, These unexpected findings portend
bone marrow transplant.” hypertension, heart failure, and type a whole new era of personalized
Peled and his team profiled fecal 2 diabetes. “These findings suggest nutrition in which specific diets based
samples taken from a large cohort that the gut microbiome functions on an individual’s gut microbiome
of cancer patients undergoing bone like an endocrine organ by generating composition could enhance a person’s
“UNDERSTANDING AND INTEGRATING
MICROBIOME VARIABILITY HOLDS POTENTIAL
TO PROMOTE PERSONALIZED PREVENTIVE
AND THERAPEUTIC APPROACHES.”
— Eran Elinav, MD, PhD
marrow transplants at four geographi- bioactive metabolites that can directly health outcomes. These findings also
cally distant transplant centers and or indirectly affect host physiology,” validate the idea that integrating
found that patients with more diverse wrote Tang in a recent review (Nat microbiome readouts in combina-
gut flora had better survival out- Rev Cardiol 2019;16:137-54). tion with genetic data offers a more
comes than those with lower diversity reliable and powerful approach to
(N Engl J Med 2020;382:822-34). PERSONALIZED assessing disease risk. “Deep pheno-
These findings imply that screening NUTRITION THERAPY typing of human cohorts, including
gut bacteria or providing interven- In addition to its diagnostic poten- the collection of microbiome data,
tions to balance the gut ecosystem tial, the human microbiome also could transform therapy develop-
prior to transplants might enhance represents an exciting new target ment,” opined Segal.
Abbve and on previous page: ChrisChrisW / Getty Images
patients’ health. for diet-based disease interventions.
A specific gut bacterial profile also Recently, several pivotal studies have GUT OVER GENETICS
has been reported in people with pul- revealed new insights into how the The Weizmann Institute team also
monary arterial hypertension (PAH) diet influences the gut microbiome, showed that a host’s genetics has
(Hypertension 2020;119:14294). This with potential implications for disease only a “minor role” in the gut micro-
signature predicted the presence of modification and treatment. biome’s composition, suggesting that
PAH with 83% accuracy. Although Most notably, a team led by Eran individualized microbiome alterations
these data are correlative, they sug- Segal, PhD, professor of computer aimed at improving clinical outcome
gest that gut microbiome changes science and applied mathematics at can be carried out across people from
eventually could become a way to the Weizmann Institute of Science in diverse genetic backgrounds (Nature
screen for the disease. However, Rehovot, Israel, developed a machine- 2018;555:210-5).
changes in the microbial ecosystem learning algorithm to integrate micro- “Understanding and integrating
are what drive changes in microbial biome data and evaluate an indi- microbiome variability holds potential
function—not merely the presence or vidual’s glycemic response to identical to promote personalized preventive
absence of specific microbial species, foods (Cell 2015;163:1079-94).. The and therapeutic approaches,” saidM AY 2020 11
Eran Elinav, MD, PhD, co-author of prebiotics, postbiotics, microbiota genetic signature of gut microbes was
both the Cell and Nature papers and transplantation, engineered bacte- 20% better than their own genes at
a professor of immunology at the riophages, microbial metabolites, discriminating between healthy and
Weizmann Institute. microbiota precision editing, and diseased individuals. The microbiome
Based on Elinav’s and others’ intestinal barrier modulation. So far, also outperformed by 50% associa-
findings, including his own, Melby’s however, just one application has tion studies predicting whether an
CIFAR colleague, Brett Finlay, PhD, advanced clinically—fecal microbiota individual had colorectal cancer.
recently put forth the provocative transplantation (FMT) to treat recur- “A big challenge is getting from
hypothesis that chronic diseases like rent Clostridioides difficile infections. correlation to causality and figuring
obesity, heart disease, and diabe- “That’s the only example where it has out mechanisms for how microbes
tes might be transmissible akin really worked and where there has are actually affecting our health,” he
to an infectious disease (Science been actual progress that has been added.
2020;367:250-1). “Data increasingly proven,” asserted Peled. Published Melby agreed that metabolomic
show that the microbiota is dysbi- reports indicate that at least 10,000 and proteomic analyses of microbiome
otic (altered) in individuals with FMT procedures take place annually, function will be key to making this
various [noncommunicable diseases] and FMT is also being investigated in research applicable to clinical settings.
NCDs … Therefore, we propose that at least 300 clinical trials. “Big data analysis and modeling is
some NCDs could have a microbial Despite accumulating data about also going to be critical as it is not
component and, if so, might be com- its efficacy, however, this treatment a particular organism or a particu-
municable via the microbiota,” wrote still faces hurdles. In mid-March the lar metabolite, but a consortium of
Finlay, co-director of the CIFAR Food and Drug Administration issued organisms that determine health or
Humans and the Microbiome Program a safety alert warning about the risk of non-health,” she noted.
and professor of microbiology and serious, even life-threatening infec- Methodological variation poses
immunology, biochemistry, and tions linked to FMT after six patients another challenge. “There are so many
molecular biology at the University of were infected with Escherichia coli fol- different methods and approaches
British Columbia in Vancouver. lowing the procedure, the second such you can take to analyze data that if
warning within a year. you put them side-by-side, you could
THE ROAD TO INTERVENTIONS As the challenges with FMT end up with varying results,” said
These emerging findings and theories illustrate, progress is slow going from Tierney. Since microbiome cohorts are
have the microbiome poised to play identifying associations to develop- relatively homogenous and limited in
an integral role in precision medicine. ing accurate and reliable methods for number, it is difficult to decide which
“We are at a point of inflection where analyzing the gut microbiome and observations are generalizable to larger
we are transitioning from observa- creating safe and effective clinical patient populations across different
tional studies and some phenomeno- treatments. geographical locations, he added.
logical mouse work to an era of deeper “Although we are starting to tap Despite these hurdles, the promise
mechanistic analysis in animal models into a lot of potential in the gut of microbiome-based clinical tests in
and to clinically actionable tests and microbiome space, it is still a long predicting, diagnosing, and treating
interventions,” said Peled. and nebulous road to achieving true diseases bodes well for the future of
The future armamentarium of clinical impact,” said Braden Tierney, a personalized medicine.
microbiome diagnostics and therapeu- computational biologist and doc-
tics offers broad and deep possibilities toral candidate at Harvard Medical Pranali P. Pathare, PhD, is a medical
for controlling and treating differ- School. His recent work posted on the writer and editor in St. Louis.
ent diseases—personalized diets, preprint server bioRxiv found that the + E M A I L : ppranali@gmail.comDECE MB E R 13 - 17 • CHICAGO, I L USA
BRING THE LAB TO LIFE SCIENTIFIC MINDS ARE POWERED BY CURIOSITY. WHAT DRIVES US INDIVIDUALLY UNITES US AS WE COME TOGETHER AS ONE GLOBAL LABORATORY MEDICINE COMMUNITY. IT’S NOW MORE VITAL THAN EVER. 300+ SESSIONS 20,000+ ATTENDEES Discover critical research impacting and advancing the Connect with global leaders in clinical chemistry, field from scientific sessions covering infectious disease, molecular diagnostics, mass spectrometry, and other emerging diagnostics, genomics and more. groundbreaking areas of laboratory science. 800+ EXHIBITORS JOIN US. Register today at meeting.aacc.org. Explore 200+ product and technology innovations at the Save with the lowest rates available until October 29. world’s largest exposition for clinical laboratory science.
14 M AY 2 0 2 0
WHAT’S NEXT on
the
POINT
OF
CARE
TESTING MENU?
From SARS-CoV-2 to cardiac biomarkers, a steady stream of IVD
innovation shows no signs of letting up BY KIMBERLY SCOTT
W
hile point-of-care (POC) testing in recent years has drastically
altered how patients are treated for conditions such as diabetes,
HIV, and cardiovascular disease, new advancements on the
horizon are expected to vastly improve near-patient treatment
for strokes, infectious diseases, and cancer, according to experts.
In vitro diagnostics (IVD) companies are working to improve specificity
and sensitivity of devices so that testing can be done on smaller specimen
samples, said Nick Collier, PhD, chief technology officer for Sagentia Medical,
a contract research organization based in the U.K. “There is a lot of
interest in reducing sample size—using capillary blood samples to do
testing, for example.”M AY 2020 15
16 M AY 2 0 2 0
At the same time, technology is Also on the infectious diseases and implementation,” she said. “Some
getting smaller, cheaper, and more front, the COVID-19 pandemic has of these we will see in cutting-edge
sophisticated. Lab-on-a-chip (LOC) spurred development of POC tests for places in the next couple of years, but
devices, which require just a few drops SARS-CoV-2, the virus that causes it will be longer before it filters down
of blood, already are in use and poten- COVID-19. In the United States, to POC in smaller hospitals or other
tially could be more widely deployed, Cepheid was first to market with a settings.”
especially in areas with limited health- rapid, near-patient test that it says will What is on David’s POC testing
care resources. In addition, diagnostics give results in 45 minutes. The Food wish list? “Procalcitonin for sepsis,
companies increasingly are combining and Drug Administration (FDA) on which would be useful in terms of
different technologies into single plat- March 21, 2020, issued an emergency curbing antibiotic resistance,” she
forms so users can perform multiple use authorization (EUA) for Cepheid’s noted. “A fingerstick [complete blood
tests on one sample, Collier added. Xpert Xpress SARS-VoV-2 test for count] test would also be wonderful.
Abbott’s i-STAT 1 POC blood use in high- and moderate-complexity But one of the problems with POC
analyzer, for example, can run multi- CLIA labs. Mesa Biotech (San Diego) testing is that if you want widespread
ple tests on one cartridge, including received an EUA March 24 for a test adoption, you have to get a CLIA
tests for cardiac markers, coagulation, that gives results in 30 minutes, and waiver. For doctors’ offices and clinics,
blood gases, chemistries, electrolytes, Abbott Labs received an EUA March getting a waiver is relatively doable,
“While there are and hematology. Roche Diagnostics’ 27 for a POC test that can deliver but getting a certificate of compli-
more than 100 cobas Liat PCR System also performs
multiple tests, using polymerase
positive results in as little as five
minutes. Other companies seeking
ance has more requirements and isn’t
always possible for most clinics.”
POC tests chain reaction technology to test for
influenza A/B, respiratory syncytial
FDA approval for POC COVID-19
tests include Becton Dickinson, bioM-
“There is a lot of interest around
sepsis diagnosis and treatment,”
available in the virus, and group A strep in about erieux, Integrated DNA Technologies, agreed Collier, noting that only a
20 minutes. LabCorp and Quest Diagnostics. few rapid tests for sepsis exist. An
U.S., not all Roche is in the process of In addition to molecular tests that example is BioFire’s BCID Panel that
are widely developing assays for other infectious
diseases, said Corinne Fantz, PhD,
analyze the viral RNA in patient
throat/nasal swabs, other POC testing
tests for 24 gram-positive, gram-
negative, and yeast pathogens, as well
implemented, director of Roche Scientific Affairs.
“We have a goal to make molecular
methods that are pending approval use
immunoassays to detect COVID-19
as three antibiotic resistance genes
associated with bloodstream infec-
such as tests for testing for sexually transmitted antibodies in blood or serum. tions. Abbott offers POC lactate
diseases [STDs] available at the point- Other companies seeking FDA testing that can be performed at a
proteins in blood of-care,” she explained. “Having the approval for POC SARS-CoV-2 patient’s bedside. While the BioFire
used for cancer ability to test for STDs in a doctor’s
office will have a big impact on treat-
tests include Becton Dickinson,
Bio-Rad, bioMérieux, Integrated
test does speed up pathogen identi-
fication, it is not yet POC because
diagnosis.” ment. The physician would be able to
get the results before a patient leaves
DNA Technologies, LabCorp, and
Quest Diagnostics. In addition to
it requires the blood to be cultured.
Collier noted that there is significant
— Kathleen David, the office, which means they can have
a discussion with the patient and
molecular tests that analyze the viral
RNA in patient throat/nasal swabs,
interest in whether the blood culture
step could be avoided, with molecular
MT(ASCP) decide on treatment.” other POC testing methods that are tests performed straight from blood to
pending approval identify the pathogen and antimicro-
use immunoassays to bial resistance genes.
detect SARS-CoV-2 Another likely trend in POC
antibodies in blood testing is use of high-sensitivity
or serum. troponin I (hs-cTn) tests in emer-
While there are gency departments and urgent care
more than 100 POC centers to diagnose heart attacks
tests available in more quickly, Collier predicted. These
the U.S., not all are assays, which were first introduced in
widely implemented, Europe in 2010, have only recently
such as tests for become available for clinical practice
proteins in blood in the U.S. Hs-cTn T allows for detec-
Left and on previous page: Greg Gibson
used for cancer diag- tion of very low levels of troponin
nosis, noted Kathleen T, helping to diagnose heart attacks
David, MT(ASCP), faster than testing sent to the central
POC testing manager lab, which in turn speeds treatment
for TriCore Reference and improves outcomes.
Laboratories in
Albuquerque, New WHEN DOES IT MAKE SENSE
Mexico. “Availability TO OFFER POC?
is one thing. Then Most physician office labs offer
there’s acceptance about five or six POC tests, oftenM AY 2020 17 for pregnancy, strep, and diabetes offering a test in-house? Fourth, what to better suit the needs of staff. If the (glucose and hemoglobin A1C), said is the cost/benefit return? “A lot of lab can’t accommodate the changes TriCore’s David. Urgent care centers the time a central laboratory can do needed, she suggested consulting with that do moderate-complexity testing testing cheaper than POC, but if you the hospital’s POC manager or coordi- typically offer additional testing, such can free up a procedure room 30 nator to determine which test would be as D-dimer tests, complete blood minutes faster and that saves $2,000, appropriate for clinicians’ needs. count, and flu testing. At hospitals, that’s a no-brainer,” David said. Payment for POC also needs to be POC testing—from prothrombin Determining the value of a considered, Fantz added. “Increasingly, time with international normalized POC test is critical to making deci- payors are looking for evidence ratio to blood gases—is performed in sions about whether to bring it that a POC test brings value over various units. in-house, commented Roche’s Fantz. tests performed in a central lab. Test Before deciding whether to offer “A common test in the emergency manufacturers typically generate this a POC test, a healthcare provider department is POC creatinine to evidence, but times are changing, and should consider several factors, determine if patients have problems the bar is getting higher every year.” experts say. First, how will the test with their kidneys,” she said. “It may be POC testing will almost certainly benefit patient care? “If it means more expensive than sending to a lab increase in the coming months and that treatment gets done faster or a but the value is in treating a patient years as technology continues to patient gets a prescription right away, faster to improve the throughput in advance. As healthcare resources are then that is a strong consideration for crowded places like the emergency stretched during the current global offering a test,” David said. Second, department.” pandemic, near-patient testing will play can the site accommodate changes Hospital department leaders should an even greater role in helping patients to workflow by offering a test—for have a conversation with central get treatment quickly and efficiently. example, drawing blood or having laboratory leaders before deciding to patients get swabbed before they even offer POC tests, advised David, who Kimberly Scott is a freelance writer who see a physician? Third, volume: Does said the laboratory might be able to lives in Lewes, Delaware. the site have enough cases to warrant improve workflow or communication + E M A I L : kmscott2@verizon.net
28 TH AACC INTERNATIONAL
CPOCT SYMPOSIUM
Emerging and
Current Trends in
Point-of-Care
Technologies
Making Faster and
Better Decisions
SEPTEMBER 30–OCTOBER 2, 2020 ∙ Montreal, QC, Canada
The 2020 AACC International CPOCT Symposium will showcase many
exciting and emerging technologies in disease diagnostics and management.
It will also examine the role of artificial intelligence, precision medicine, and
IT-based advances in POCT that explores cybersecurity threats and trends.
With over two and a half days in Montreal, Canada, you will have plenty of
opportunities to learn from, and network with interdisciplinary experts from
all over the world.
Register today at www.aacc.org/cpoct
Developed in cooperation
with the Canadian Society
of Clinical Chemists (CSCC)M AY 2020 19
World Sees Explosion of Regulatory Authorizations for
SARS-CoV-2 Tests
As the COVID-19 epidemic has intensified, diagnostic manufacturers have rushed
to develop tests for SARS-CoV-2, leading to an unprecedented flood of diagnostic
regulatory authorizations. In the U.S., Cepheid’s Xpert Xpress SARS-CoV-2 test
and Abbott’s ID NOW COVID-19 test became two of the first rapid point-of-
care tests for the virus to earn Food and Drug Administration (FDA) emergency
Regulatory use authorizations (EUA). Other companies that had received FDA EUAs for
SARS-CoV-2 tests at the time CLN went to print include LabCorp, Quest,
Roundup Hologic, bioMérieux, PerkinElmer, Luminex, Quidel, BGI Americas, Sentinel
Diagnostics, Primerdesign, DiaSorin, GenMark, and Avellino Labs. Almost all of
the tests that FDA has authorized so far are molecular assays, but serological tests
are also starting to come to market, such as Diazyme’s DZ-Lite SARS-CoV-2 IgG
and SARS-CoV-2 IgM CLIA test kits. Additionally, the Centers for Disease
Control and Prevention (CDC) qualified and approved primer and probe kits
manufactured by LGC, Biosearch Technologies and Integrated DNA
Technologies that are designed for labs implementing CDC’s SARS-
CoV-2 test.
While an inability to test widely hamstrung the U.S.’s initial
response to COVID-19, this sudden profusion of SARS-
CoV-2 tests has not been without its drawbacks. In
particular, FDA has needed to caution consumers against
using unauthorized, fraudulent test kits that some
companies are marketing as at-home tests for
COVID-19.
Outside the U.S., Thermo Fisher, BGI, DiaCarta,
AusDiagnostics, Bioneer, 3-Dmed, Genomica, Osang
Healthcare, Co-Diagnostics, Vision Medicals, Credo
Diagnostics, a collaboration between CerTest and BD,
and SolGent have all received the CE mark for their
SARS-CoV-2 tests. SolGent’s test also received EUAs
from Korean and Philippine regulatory authorities.
Elsewhere in Asia, Fosun Long March and Rendu
Biotechnology earned Chinese regulatory approval for their
tests, while an assay developed by the Agency for Science,
Technology, and Research and Tan Tock Seng Hospital gained
provisional authorization from Singapore.
■ Amendments of 1988 (CLIA) Waiver comparable performance between a
FDA RELEASES GUIDANCE TO AID Applications for Manufacturers of In waived user and a moderately
MANUFACTURERS APPLYING FOR Vitro Diagnostic Devices,” provides an complex laboratory user to demon-
Julia Garan / Getty Images
CLIA WAIVERS update to FDA’s 2008 guidance for strate device accuracy.
T he Food and Drug
Administration (FDA) has
finalized two guidance documents
manufacturers who are submitting
CLIA waiver applications. Specifically,
in compliance with the 21st Century
The second new guidance,
“Recommendations for Dual 510(k)
and CLIA Waiver by Application
related to CLIA waiver submissions. Cures Act, FDA revised Section V of Studies,” includes recommendations
The first guidance, “Recommendations the 2008 CLIA Waiver Guidance to for designing a single set of compari-
for Clinical Laboratory Improvement include the appropriate use of son and reproducibility studies that20 M AY 2 0 2 0
Mycoplasma hominis, and Ureaplasma
urealyticum. The test uses Randox’s
Biochip Array Technology, which
enables simultaneous multi-analyte
testing on one undivided sample by
combining a panel of related assays
on a single biochip with a single set
of reagents, controls, and calibrators.
The test is performed on the Vivalytic
system, a point-of-care platform that
Randox developed in partnership
with the German technology com-
pany Bosch. Randox’s STI test is also
fully automated and provides a full
molecular workflow, from extrac-
tion and polymerase chain reaction
amplification through detection.
Additionally, it does not require the
use of additional peripheral equip-
ment such as a laptop or keyboard,
bar-code scanner, or filling stations.
■
DXTERITY GETS CE MARK FOR
AT-HOME FINGERPRICK BLOOD
COLLECTION DEVICE
T he CE mark has been granted
to DxTerity Diagnostics for
the DxCollect MicroCollection
Tube (MCD), which collects and
may support dual 510(k) clearance progress to cervical cancer. The preserves 100 μL of fingerstick
and CLIA waiver submissions. With CINtec PLUS Cytology test identifies blood for DNA- and RNA-based
this guidance, FDA hopes to increase those women whose HPV infections genomic testing. Unlike DNA test-
use of the agency’s Dual 510(k) and are most likely to progress in this ing, which can be performed from
CLIA Waiver by Application pathway manner and who would benefit from saliva or a cheek swab, RNA-based
in order to expedite the process of immediate referral to colposcopy genomic testing usually requires a
bringing new in vitro diagnostic tests versus repeat testing. The test detects blood sample that is collected into
to CLIA-waived settings. the simultaneous presence within a specialized tubes and often shipped
single cell of the two biomarkers p16 on dry ice. The DxCollect MCD sta-
■ and Ki-67, an abnormality that is bilizes both DNA and RNA at room
FDA APPROVES ROCHE TEST FOR associated with HPV infections that temperature, enabling specimens to
TRIAGING HPV-POSITIVE are transforming. Additionally, labs be shipped under ambient condi-
SCREENING RESULTS can perform the test using the same tions using standard mail. The device
R oche has received Food and
Drug Administration approval
for the CINtec PLUS Cytology,
liquid sample that is used for HPV or
Pap cytology testing.
has been evaluated in large-scale,
direct-to-patient clinical studies.
Following receipt of the CE mark,
making this the first commercially ■ DxTerity is now focused on gain-
available biomarker-based triage test CE MARK GIVEN TO RANDOX’S ing Food and Drug Administration
for women whose primary cervical MULTIPLEX STI ASSAY approval for the MCD in conjunction
cancer screening results are positive
for the human papillomavirus (HPV)
using Roche’s cobas 4800 HPV test.
R andox Laboratories has
earned the CE mark for its
cartridge-based sexually transmit-
with the company’s Modular Immune
Profile assay, which is intended for
home testing of systemic lupus ery-
RossHelen / Getty Images
While most HPV infections resolve ted infection (STI) assay, which tests thematosus (SLE) patients. DxTerity
on their own, some women who for 10 of the most common STIs: hopes that regular monitoring of
test positive for the virus or whose Chlamydia trachomatis, Neisseria autoimmune patients using the MCD
co-testing results are inconclusive— gonorrhoeae, Trichomonas vaginalis, will enable physicians and patients
HPV-positive and Pap cytology- Mycoplasma genitalium, Treponema to more effectively manage SLE by
negative—develop pre-cancerous pallidum (syphilis), herpes simplex predicting potential flare-ups before
cervical lesions that, if left untreated, virus 1 and 2, Haemophilus ducreyi, they happen.New Aptima® assays
are evolving the standard
in vaginitis testing.
Vaginitis is the number one reason women visit their Ob-Gyns each year1.
Traditional, subjective tests can miss co-infections, often leading to inadequate
treatment.2,3 The Aptima® vaginitis assays are evolving the standard, offering:
OBJECTIVE detection of the three most common causes of infectious
vaginitis: bacterial vaginosis, candida vaginitis, and trichomoniasis2,3
COMPREHENSIVE testing using one simple swab2,3
ACCURATE results using nucleic acid amplification test (NAAT) technology
to deliver excellent sensitivity and specificity2,3
N OW F DA - C LE A R E D
RUN ON
For more information, visit hologic.com/AptimaVaginalHealth
References: 1. Kent HL. Epidemiology of vaginitis. Am J Obstet Gynecol. 1991 Oct;165(4 Pt 2):1168-76. 2. Aptima BV Assay [package insert] #AW-18811, San Diego, CA; Hologic, Inc., 2019.
3. Aptima CV/TV Assay [package insert] #AW-18812, San Diego, CA; Hologic, Inc., 2019.
ADS-02695-001 Rev. 001 © 2019 Hologic, Inc. All rights reserved. Hologic, Aptima and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or
its subsidiaries in the United States and/or other countries.22 M AY 2 0 2 0
Thermo Fisher to Acquire Qiagen for $11.5 Billion
Thermo Fisher Scientific announced it will acquire the molecular diagnostics-
focused firm Qiagen for $11.5 billion.
Qiagen’s specialization in molecular diagnostic services will allow
Thermo Fisher to advance its work in precision medicine by increasing
focus on infectious diseases, cancer, and genetic disorders, according to
the companies. Specifically, Thermo Fisher plans to expand utilization of
Qiagen’s Quantiferon-TB Gold Plus latent tuberculosis detection test, the
Industry QiaSymphony platform for molecular diagnostics infectious disease testing,
and the QiaStat-Dx syndromic testing system. These platforms add to Thermo
Playbook Fisher’s existing portfolio of quantitative polymerase chain reaction,
next-generation sequencing, Sanger sequencing, and microarray
technologies.
Thermo Fisher will also take advantage of Qiagen’s
sample prep technologies, assays, and bioinformatics
solutions to expand its life sciences products, including
existing reagents and consumables.
"This acquisition provides us with the opportunity
to leverage our industry-leading capabilities and
[research and development] expertise to accelerate
innovation and address emerging healthcare
needs," said Marc Casper, chairman, president,
and CEO of Thermo Fisher Scientific. The deal is
expected to be finalized in 2021.
Qiagen recently announced development of
its QiaStat-Dx Respiratory SARS-CoV-2 Panel
test for diagnosing patients with COVID-19. The
Food and Drug Administration granted Qiagen
an emergency use authorization for the test that
can differentiate the SARS-CoV-2 coronavirus from
21 other respiratory pathogens in patients. Using
nasopharyngeal swab samples, the test specifically targets
two genes that help detect the COVID-19 pathogen.
■ COVID-19. However, two recent companies intend to begin offer-
BIODESIX, BIO-RAD SEEK EUA FOR studies in China found that the ing this test in the U.S. once they
COVID-19 TEST ddPCR test can be significantly more receive EUA.
B iodesix and Bio-Rad
Laboratories have partnered
on a droplet digital polymerase chain
sensitive in diagnosing patients before
symptoms develop.
The studies showed that patients
■
GRANT FUNDING GOES TO
reaction (ddPCR) test for SARS- who underwent qPCR tests had the TUBERCULOSIS DETECTION ASSAY
CoV-2. At CLN press time, the com-
panies were hoping to gain Food and
possibility of showing false negatives
or false positives. The studies also F ollowing an initial $500,000
grant from the Bill & Melinda
sanjeri / Getty Images
Drug Administration emergency use saw a difference in accuracy with Gates Foundation, Biological
authorization (EUA) for this test. detection numbers increasing from Dynamics announced a secondary
Some laboratories have been using 28.2% with qPCR tests to 87.4% grant of about $1 million from the
quantitative PCR (qPCR) tests for with ddPCR tests. Though the studies foundation for a tuberculosis (TB)
patients who show symptoms of have not been peer reviewed, both detection assay. The molecularYou can also read
