Bracing for Flu Season in a Pandemic World
How clinical laboratories can prepare as COVID-19 meets influenza
It’s officially autumn in the United States, which means pumpkin picking, college football, and, of course, the start of flu season. This annual occurrence is always a challenge for clinical laboratories, but this year, circulation of the influenza virus coincides with the ongoing COVID-19 pandemic, creating a new set of uncertain circumstances.
This situation is unique—flu season severity is largely unpredictable, and since we still have a lot to learn about SARS-CoV-2, healthcare experts aren’t sure how the two pathogens will interact. Meanwhile, labs and their vendors continue to face supply chain issues that could make it difficult to stock enough reagents, consumables, and test kits for a high-demand season.
Sherry Dunbar, PhD, MBA, Senior Director of Global Scientific Affairs has been working hard to raise awareness of the different challenges we should prepare for when the current pandemic meets flu season in the US.
To help the clinical lab community prepare for this situation, Dr. Dunbar recently published articles in Medical Laboratory Observer and Clinical Lab Manager. (And for clinical lab members, the MLO article offers Professional Acknowledgment for Continuing Education credits!)
Dr. Dunbar’s article in Medical Laboratory Observer describes both challenges and solutions for labs navigating flu season amid the pandemic. The highlights are summarized here:
- Labs will need more testing. “At a minimum, the pandemic means that clinical labs will not be able to rely solely on tried-and-true flu tests,” Dr. Dunbar writes. “Depending on local prevalence of COVID-19 infections, each lab will have to determine whether to add SARS-CoV-2 testing for all patients with respiratory symptoms, or whether they will need an algorithm to select which patients get tested for both flu and COVID-19.”
- Rapid molecular tests are recommended. The Infectious Diseases Society of America now recommends against using rapid antigen tests for influenza due to low sensitivity, and encourages the use of rapid molecular tests. “While these are typically not as fast as the 15-minute rapid antigen tests, they often produce results in just a few hours, which still allows healthcare providers to deliver same-day answers to patients along with guidance for the most appropriate treatment, if any,” Dr. Dunbar notes.
- Combination tests could ease supply-chain issues. Implementing a mini panel test covering influenza A/B, respiratory syncytial virus (RSV), and SARS-CoV-2 can reduce the total number of tests run, deliver results faster, and utilize fewer reagents and consumables. This mini panel test also enables co-infection case identification.
Although it’s difficult to predict how severe influenza will be each year, and there is still some uncertainty about how the pandemic will change this year’s flu and respiratory season, there are a number of ways clinical labs can prepare that may help reduce the burden on the healthcare system. Since there is significant overlap in symptoms for both COVID-19 and the flu, it’s important that labs prepare for an influx of testing as soon as possible, even if the flu season in the southern hemisphere was less severe than experts anticipated.
To support the detection of COVID-19 during the upcoming flu season, Luminex has developed a number of rapid molecular tests that detect SARS-CoV-2. One of these tests is the ® Respiratory Pathogen Panel” href=”https://us.diasorin.com/en/molecular-diagnostics/kits-reagents/by-disease?f%5B0%5D=disease_mdx_fyk%3A253″>NxTAG® Respiratory Pathogen Panel, offers a comprehensive view of a patient’s health by detecting 21 common respiratory pathogens.
For more information about our additional SARS-CoV-2 testing solutions, check out our website!
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5 Ways Luminex Can Support Your Antimicrobial Stewardship Efforts
Rapid diagnostic molecular assays can have a tremendously positive impact on patient care, but only if they are quickly implemented and results are utilized by clinical stakeholders.
This is most apparent with the introduction of rapid blood culture tests. The VERIGENE® Gram-Positive and Gram-Negative Blood Culture Tests are critical, frontline tools that are used by clinicians every day to help optimize treatment decisions. To ensure you get the most from these tests, Luminex® offers several valuable resources to help integrate them into your hospital’s Antimicrobial Stewardship efforts.
One of these resources is Luminex’s Clinical Implementation Program. Clinical Implementation Managers (CIMs) are RN-level team members who help navigate the process of taking VERIGENE Blood Culture tests live and increase utilization. Best practices have shown that the earlier CIMs are brought into the implementation timeline, the sooner results can make a difference. CIMs’ expertise is not limited to blood culture implementation—they can also assist with go-live processes for the complete VERIGENE® test menu.
CIMs are not sales representatives—they’re expert strategists who have peer-to-peer conversations with your clinical team to help determine your specific needs. Since launching the Clinical Implementation Program, we’ve identified the top five areas where we most commonly provide assistance:
- IT Department: Believe it or not, the IT department is often the slowest to implement new testing, largely because of the strict guidelines they have for ensuring the security of online systems, and because of the numerous departments they support. Luminex’s CIMs can help with reporting language, and LIS examples from other institutions can be used to drive result reporting. Along with Luminex’s Applications Team, CIMs can also help guide specific server-related questions to our internal IT Implementation Manager for further assistance.
- Assay Verification: In partnership with the lab and our Applications Team, CIMs can help resolve differences between your current methodology and the VERIGENE tests. As assays advance through the go-live process, CIMs can check in to see how testing is going, as well as perform post go-live follow-up with the lab to monitor results. CIMs can also offer proactive check-ins to ensure a smooth transition to live testing.
- Partnership with Antimicrobial Stewardship: CIMs can develop one-on-one relationships with clinical stakeholders and lead multi-disciplinary meetings with pharmacy, lab, critical care, and infection control teams. In these meetings, the pathway to success can be mapped out to give more in-depth background on assays and develop plans for education. One size does not fit all, and some hospitals may be in earlier stages of antimicrobial stewardship development than others. CIMs can help create a success plan based on the hospital’s unique starting point.
- Treatment Algorithms: How will the results be handled? It’s a question of whether the pharmacy or the physician will be the point person for results. Not sure? That’s OK. CIMs can help fill the gaps with examples and technical information from other sites using the VERIGENE platforms.
- Education: CIMs can offer peer-level conversations and Clinical Education Recognition Points, or CERP-accredited presentations, for critical and acute care nurses. They can also partner with Medical Staff Services to coordinate Continuing Medical Education (CME) programs through the hospital. Through follow-up education, Luminex can help you proactively monitor the implementation of a new workflow, identify any remaining knowledge gaps, and get the most from your test results.
The goal is for the lab and Antimicrobial Stewardship Teams to incorporate your VERIGENE test results into patient treatment decisions and, ultimately, improve patient outcomes.
For more information on Luminex’s Clinical Implementation program, please contact your local Molecular Business Manager.
In Germany, Screening for COVID-19 with the ARIES® System
Clinical lab scientist describes his experience establishing a two-step diagnostic algorithm for COVID-19
Scientists in clinical labs worldwide have worked night and day in the COVID-19 pandemic to develop, validate, and implement new diagnostic tests for patients believed to be infected by the SARS-CoV-2 virus. While each lab’s experiences are slightly different, there are certain universal themes. We spoke with Dr. Thomas Juretzek, a molecular biologist at the Carl-Thiem-Klinikum (CTK) Hospital in Cottbus, Germany, to learn about how he got an in-house screening assay up and running.
Juretzek used the Luminex ® CoV Extended Panel” href=”https://us.diasorin.com/en/molecular-diagnostics/kits-reagents/simplexa-covid-19-direct#molecular”>Luminex NxTAG® CoV Extended Panel, which was implemented in parallel to the
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Luminex’s Flexible SARS-CoV-2 Assays Enable Both High-Throughput and Emergency Testing
Federal funding and FDA Emergency Use Authorization streamlined development and commercialization of these new assays.
As the COVID-19 pandemic swept across the globe, people everywhere have raced to respond. The Luminex team has been working around the clock on much-needed molecular diagnostic assays for the SARS-CoV-2 virus, two of which recently received Emergency Use Authorization from the FDA.
Why not focus on one assay instead? As we see it, labs around the world need as many types of diagnostic tests as possible to address this pandemic, and it is crucial to get these new tests up and running quickly. Many can’t spare the time it would take to evaluate and install an entirely new diagnostic platform.
That’s why we developed assays for two of our most popular platforms, which are already in use in labs all around the world. The ARIES® SARS-CoV-2 Assay runs on our FDA-cleared, automated sample-to-answer ARIES® System, which is designed for moderate-complexity labs and generates results in about two hours. The ARIES® System can run up to 144 tests per day, requiring no specialty training and minimal human interaction. We also launched the NxTAG® CoV Extended Panel, which is a high-throughput, scalable, cost-effective option for detecting SARS-CoV-2 in up to 96 samples in approximately four hours. The NxTAG CoV Extended Panel, which can be run on our compact MAGPIX® System, can also be used in parallel with the NxTAG® Respiratory Pathogen Panel to provide a more complete picture of a patient’s respiratory health. The MAGPIX System can run more than 500 tests per day.
It’s important to note that we didn’t do this alone. Luminex is very grateful to have received support from the Biomedical Advanced Research and Development Authority—part of the US Department of Health and Human Services. Each of our new SARS-CoV-2 tests was supported with a BARDA contract for $642,450.
In a statement announcing this news, Luminex CEO and President Nachum “Homi” Shamir said: “We are partnering with our customers at clinical laboratories to address the global pandemic, providing fast, reliable, scalable, multiplex tests that can help stem the spread of COVID-19 disease, while also ensuring that our tests are cost-effective.”
Sherry Dunbar, PhD, MBA, is the Senior Director of Global Scientific Affairs at Luminex.
The NxTAG CoV Extended Panel and the ARIES® SARS-CoV-2 Assay have each been funded with $642,450 of Federal funds, approximately 36% each of the expected overall cost of development, from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract Nos. 75A50120C00037 (NxTAG CoV Extended Panel) and 75A50120C00043 (ARIES® SARS-CoV-2 Assay). Luminex financed the remaining $1,118,663 of each program, constituting 64% each of the total program costs.
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- Luminex Diagnostic COVID-19 Offerings [Webpage]
- xMAP® Technology for Multiplex COVID-19 Serology Assays [Webpage]
- Considerations Regarding RNA Extraction Kits for SARS-CoV-2 Detection [Blog]
- How Luminex Is Supporting Research Partners’ Pandemic Response [Blog]
- Questions to Ask When Choosing a Multiplex Assay Kit[Blog]
Rare but Not Alone – Raising Awareness for Rare Diseases
Join us on Rare Disease Day to honor patients, caregivers, doctors, and scientists.
On February 29—a day that only occurs once every four years—people around the world will celebrate Rare Disease Day. It’s a special opportunity to think about those who are affected by rare diseases, the researchers and physicians who work to help them, and what the rest of us can do to make a difference.
Around the world, more than 300 million people are estimated to have a rare disease—that’s nearly equivalent to the entire U.S. population. While there are over 6,000 identified rare diseases and each disease may only affect a few people, every patient living with these conditions shares several common challenges: a lack of funding for research to address their disease, too few people affected to have a robust patient advocacy group, and little familiarity with their symptoms and prognosis among the general public, and even among physicians.
The goal of the Rare Disease Day campaign is to raise awareness about these conditions so that access to diagnostics, treatment, and support options becomes more readily available. The diseases these patients are affected by may be rare, but adequate healthcare is a universal need.
This year marks the 13th annual Rare Disease Day, which is celebrated on the last day of February—whether it’s a leap year or not. People in more than 100 countries are hosting events to raise awareness for specific rare diseases, or for rare diseases in general. If you’re interested in participating, check out planned events in the U.S. and around the world. They include meetings, fundraising walks, sports events, competitions, and more. You can also pin on a blue denim ribbon to show your support for the rare disease community!
Here at Luminex, we are longtime supporters of this cause and we advocate for the patients and caregivers who have to navigate these challenging diagnoses. Rare diseases are especially important to us because most have genetic causes, which means that our technology can play a valuable role in helping affected families get answers about their condition. Scientists use our multiplex xMAP® Technology for rapid development of new assays to diagnose both existing and novel rare diseases.
As an official supporter of Rare Disease Day, we ask that you join the Luminex family and so many other advocates around the world by helping raise awareness for everyone affected by rare disease. Get out there and #ShowYourRare!
METHODS Special Issue: Clinical and Analytical Performance Data for NxTAG® RPP
Highly scalable, multiplex molecular assay is comparable to xTAG® RVP performance
If you’ve ever used an assay based on xTAG® Technology, you may wonder how the newer NxTAG® Chemistry stacks up. A new publication in Methods uses clinical and analytical data from respiratory pathogen panels to demonstrate how both performance and workflow have improved with NxTAG Technology.
The publication, “Multiplexed detection and identification of respiratory pathogens using the NxTAG® Respiratory Pathogen Panel,” was written by Luminex researchers and collaborators at several clinical labs. In addition to performance data, the paper also includes a detailed assay protocol for using the NxTAG® Respiratory Pathogen Panel (RPP).
NxTAG RPP is the latest in a series of multiplex molecular assays developed for the detection of respiratory tract infections. The xTAG® Respiratory Viral Panel (RVP)—which detected as many as 19 common respiratory viruses and subtypes—was “the first multiplexed molecular assay for respiratory pathogens cleared for in vitro diagnostic use,” as the authors note. A subsequent test, the xTAG RVP FAST, was also cleared for in vitro diagnostic use. At the end of 2015, NxTAG RPP was launched based on “the newest generation of universal tag sorting chemistry from Luminex,” the scientists write. “NxTAG RPP incorporates multiplex RT-PCR, with the universal tag system in the form of lyophilized reagents, to provide a closed system for amplification and detection of 20–21 respiratory viral and bacterial targets.” After extraction, all steps occur in a single tube for a streamlined workflow that requires minimal hands-on time.
Results of the Study
Results included in this study came from four clinical sites; more than 2,000 nasopharyngeal swab specimens were collected from children and adults. Over 95% of samples “generated valid NxTAG RPP results for all analytes on the first attempt,” the authors report. “All available residual specimens were re-run with NxTAG RPP, and generated valid results upon re-test.”
Detailed analyses of the assay’s performance demonstrate its reliability. “As presented here, the clinical performance is comparable to that of the original xTAG RVP assay, with sensitivities of >92.9% and specificities of ≥96.3% for most pathogens,” the authors write. Clinical specificity “ranged from 96.3% to 99.9% for the viruses and 99.9% to 100% for the bacterial pathogens.” That means NxTAG RPP has comparable clinical performance to the xTAG RVP assay, and its analytical performance is as good as or better than the xTAG RVP and xTAG RVP FAST assays.
The scientists note that “a particular strength of a multiplex panel, such as NxTAG RPP, is the ability to detect coinfections.” In the study reported, coinfections were identified in almost 18% of samples. “While many of the causative organisms are treated similarly, the ability to accurately detect the organisms present and the most likely pathogen is very important when confronted with several organisms in a sample which are of varying risk to the patient,” they report.
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- Advances in Bead-Based Biomarker Detection [Methods xMAP Issue]
- View the latest xMAP® Insights Newsletter [Online & Download]
- Browse 1,200+ Partner Kits with xMAP® Kit Finder [Online Tool]
- xMAP® Cookbook to Design Your Own Assays [Download]
- View the xMAP® Webinar Blog Series [Video]
- Getting Started with xMAP® Technology [Video]
- Respiratory Infection Portfolio [Web Page]
For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.
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