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How Better Diagnostics Technology Could Thwart Tomorrow’s Pandemics

Pandemic preparedness requires long-term investments in disease surveillance, diagnostics, therapeutics, and vaccine research.

By Jack Regan, PhD, CLP, JUNE 2021

The United States’ COVID-19 response was ineffective at containing the spread of the virus, leading to high case counts, hospitalizations, and deaths. Beyond basic preparation, planning, education, and leadership, there remains a profound technology gap, posing a risk for the remainder of this pandemic and for the management of the next one. The technology exists to help us better mitigate the risk, but supporting the development and deploying these advancements will require the support of the federal government. Pandemic preparedness requires long-term investments in disease surveillance, diagnostics, therapeutics, and vaccine research. Diagnostics is an area that has been largely underfunded, despite the repeated and consistent warnings from virologists, microbiologists, epidemiologists, and other public health stakeholders. Years of underfunding diagnostics and inadequate testing policies have left us vulnerable to microbial attack, and SARS-CoV-2 has been just that sort of reckoning. Even though we are not through fighting COVID-19, we must recognize that a similar threat will likely emerge in the not-too-distant future, and we must take steps now to prevent such a catastrophe.

The Need for Point-Of-Care
Improving the capabilities of reference laboratories alone is not adequate to address our infrastructure needs, especially given their historically slow turnaround times. If a reference lab is processing hundreds of samples a day for a novel virus, then initial containment efforts have failed. The solution should not be to continue to expand the capacity of these reference laboratories to handle tens of thousands of samples daily, but instead, to support the deployment of more point-of-care (POC) tests that can rapidly return actionable results. The faster accurate results are returned at the POC, the better the chances of limiting additional viral spread.

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POC News

2021 AACC Moved to Atlanta Sep 26-30

AACC has announced that they have moved the location of the 2021 annual meeting from Anaheim, CA to Atlanta, GA. The meeting dates have also been changed to one week later: September 26-30, 2021.Read more >

Daily COVID-19 Updates on CAP Today Website

COVID-19 Jan 2020
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AACC POCT Coordinator of the Year Award | Deadline: August 15

The Point-of-Care Testing (POCT) Coordinator Award is given annually to recognize outstanding achievements in the POCT field by persons who are primarily responsible for a given institution’s POCT program. The award is not limited to persons or programs within the United States. To nominate yourself or a colleague, click here >

CLSI publishes new guidelines on managing laboratory records

MLO - May 2021 - The Clinical and Laboratory Standards Institute (CLSI) has published the first edition of QMS26—
Managing Laboratory Records.

QMS26 is intended to help laboratories meet quality management system requirements for the records portion of quality-system essential documents and records management. It presents recommendations for developing a records management program, including designing, creating, reviewing, retaining, and disposing of laboratory records.

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Artificial Intelligence Is Poised to Transform Point-of-Care Testing

In both research and practice, advanced software is being deployed to develop new kinds of instruments and help clinical laboratorians monitor quality.

Author: Jen A. Miller // APR. 2021 // Source: Clinical Laboratory News - Artificial intelligence (AI) and machine learning (ML) continue to become more prevalent in healthcare. The AI-associated healthcare market is on track to reach $6.6 billion this year, according to Accenture. AI applications could create opportunities for $150 billion in healthcare cost savings by 2026. And the use of these technologies has even expanded into the field of point-of-care testing (POCT). As more tests move out of the core laboratory and are performed by nonlaboratory professionals, AI and ML are being used to make POCT cheaper, faster, and easier to check for quality control.

“We generate a lot of data with POCT and in our core laboratories,” said James Nichols, PhD, DABCC, FAACC, professor of pathology, microbiology, and immunology and medical director of clinical chemistry and POCT at the Vanderbilt University Medical Center. “We haven’t even really scratched the surface on what we can do with that data.”

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Preparing labs for diabetic testing levels after COVID-19

MLO, by Shamiram Feinglass MD, MPH - There is plenty of evidence that individuals with diabetes are at an increased risk of COVID-19. A retrospective observational study of 1,122 COVID-19 adult patients in 88 U.S. hospitals found that patients with diabetes and/or uncontrolled hyperglycemia had higher mortality rates and longer hospital stays than patients without these conditions. A report from New Orleans claims that 97 percent of people killed by COVID-19 in Louisiana state had a pre-existing condition, and nearly 40 percent of those who died had diabetes.

The coronavirus pandemic has placed an additional mental and physical burden on people with underlying health conditions, like diabetes. The pandemic has moved routine doctor visits to telemedicine and made outings to pick up medicine or get blood drawn yet another risk for exposure.

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FDA approves OTC and POC COVID-19 tests

MLO - April 2021 - The U.S. Food and Drug Administration (FDA) approved amended emergency use authorization (EUA) requests for multiple tests this week, expanding over-the-counter and point-of-care testing options for COVID-19, the agency said in a news release. “The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable,” the FDA said. The authorizations the FDA approved are:

  • Quidel QuickVue At-Home OTC COVID-19 test - authorized for OTC at-home serial screening
  • Abbott BinaxNOW COVID-19 Antigen Self Test – authorized for OTC at-home serial screening
  • Abbott BinaxNOW COVID-19 Ag Card 2 Home Test – authorized for OTC at-home serial screening with telehealth
  • Abbott BinaxNOW COVID-19 Ag 2 Card – authorized for POC serial screening without a prescription
  • BD Veritor System for Rapid Detection of SARS-CoV-2 – authorized for POC serial screening with a prescription

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Lab administrators prioritize accurate and timely financial and operational performance

Februrary 2021 - MLO | While clinical labs have long faced operational challenges and financial pressures, the magnitude
of these issues during the COVID-19 pandemic has been unprecedented. Clinical lab administrators face shrinking reimbursements, staff shortages and supply chain disruptions at a time when test volumes are through the roof. The ability
to perform accurate and timely analytics on operational and financial performance has never been more critical. In our first
of four “State of the Industry” survey topics for 2021, MLO explored clinical data analytics adoption among labs, including opportunities to leverage analytics to support lab operation and management, and factors holding them back from
data-based performance improvement initiatives.  

Among survey respondents, 62% are in leadership positions, such as lab managers, administrators, supervisors, lab directors and section/department managers, with most working in hospital labs. The remaining respondents represent a broad range of job functions across a variety of facilities and lab sizes.  

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For POC Molecular, Pauses, Plans and Testing Precautions

CAP Today, January 2021 , By Amy Carpenter Aquino

The use of molecular assays at the point of care is exciting but a bit scary. That’s how Raquel Martinez, PhD, D(ABMM), director of clinical and molecular microbiology at Geisinger Medical Laboratories, described the state of the science for molecular infectious disease POC testing when she spoke in a virtual AMP session in November with Omai Garner, PhD, D(ABMM), of UCLA Health.

“There are many ways for these molecular tests to go wrong, so testing sites need to introduce these tests carefully,” Dr. Martinez said, emphasizing the benefit to bringing highly sensitive molecular testing to the point of patient care.

When laboratories are not in control of the testing, she noted, there can be gaps in the understanding of environmental requirements, workflow, cleaning protocols, biosafety, and compliance. Read more >

In SARS-CoV-2, small steps but big wins

CAP Today, December 2020, By Karen Titus
By its very nature, the global pandemic has forced laboratories to look far and wide, to bring binoculars, in essence, to their views of supply chains, testing platforms, personnel, and the like. As COVID-19 churns on, some labs are looking through a tinier lens as well. These labs aren’t trading their binoculars for a jeweler’s loupe, exactly, but they have found small and significant success stories closer to home.

Like so many others, Erin Graf, PhD, D(ABMM), has confronted a spinning roulette wheel since the pandemic’s start. In a talk she gave in an AMP webinar in October (she also spoke with CAP TODAY in a follow-up interview), Dr. Graf, director of microbiology, Mayo Clinic in Arizona, posted a vibrantly colored wheel titled, “Which supply chain issue will impact us this week?” Each segment contained a phrase familiar to everyone in 2020, ranging from “swabs” and “sheep blood agar” to “pipette tips” and “chlamydia and gonorrhea tests.”

As she surveys these continuous claims on her attention, Dr. Graf says, “I think none of us could have ever thought that COVID would have an impact on all these arms of the testing that we do.” Read more >

Coronavirus: Guidance for Better Mental Health

During the COVID-19 pandemic, there will be a lot of information about the virus and its effects on mental health. That’s because coronavirus and the social, financial and psychological implications it carries can seriously impact one’s mental wellbeing. Government legislation, mass media coverage, and the increasing global death toll will cause a lot of stress, especially for the older population, children, and people with a history of mental health problems.

It’s of the utmost importance that we try to remain as composed as we can during this time. The fear and anxiety that is gripping the nation are as contagious, if not more so than the illness itself. Learn more >

Know the Curves Guide to COVID-19 Testing

Educational guide helps anyone understand COVID-19 testing
Testing is an important tool in the fight against COVID-19. But many people are still confused about the different types of tests that are available. This simple, non-commercial, guide is written in clear language so anyone can understand:

  • The difference between viral RNA, antigen, and antibody testing
  • Why it’s important to get the right test at the right time
  • What a positive result means
  • When people are most contagious
  • And more

Feel free to forward this to patients, friends, family, and anyone else who might be interested. Download the PDF here.

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