Video: What You Need to Know About Customizable Respiratory Testing

By Chris Gardner

Watch MLO’s interview with Diasorin executives discussing the latest challenges and innovations in a shifting respiratory landscape

At this year’s annual meeting of the Association for Diagnostics & Laboratory Medicine, Diasorin team members were interviewed about the trends in respiratory testing by Mark Hagland, contributing editor to Medical Laboratory Observer, better known to readers as MLO.

Two of our respiratory testing experts were interviewed: Michelle Tabb, Chief Scientific Officer, and Giulia Amicarelli, Vice President of Global Molecular Marketing and Marketing Services. Together, they offered terrific insight into the shifting landscape, current challenges, and the latest innovations in respiratory testing.

Watch the quick video to learn more. Featured here are a few of their top insights:

Market changes

The rise of diagnostic stewardship has led to more laboratories aiming to run the right test for the right patient at the right time. Yet making that decision can be incredibly complex for respiratory testing in a post-pandemic world, with varying viruses circulating alongside SARS-CoV-2 depending on the season and population. Therefore, having flexibility in which pathogens to test for based on patient type is key.

Lab challenges

It’s no secret that clinical labs are facing a perfect storm of challenges: rising costs, staff shortages, and increased demand. Diagnostic stewardship approaches help address some of these issues, and many clinical labs are examining the overall pathogen prevalence, platform selection, and algorithm development to make their processes more efficient.

Helpful innovation

To help labs achieve their diagnostic stewardship goals, provide high-quality respiratory testing to patients, and streamline their workflows to ease the burden on staff, Diasorin recently launched its LIAISON PLEX® System and the LIAISON PLEX® Respiratory Flex Assay. The system utilizes a new approach that allows users to benefit from syndromic testing while customizing reported targets to prevent unnecessary over testing. This is the first fully customizable syndromic test for respiratory infections, designed to fit within current reimbursement strategies, and enables target selection according to patient needs, using a single workflow and testing platform.

To learn more about respiratory testing (and earn free CE credits!), check out this MLO article on the value of flexibility in respiratory testing.

The Post-Emergency Reimbursement Landscape for COVID-19 Testing

By Bridget Parsons

A review of the coverage you can expect for performing 87635 diagnostic services

Since the end of the COVID-19 pandemic, it has been a challenge for clinical lab teams to monitor new reimbursement policies related to COVID-19 testing now that it is no longer a public health emergency. Will CPT code 87635* for COVID-19 molecular testing still be covered? The short answer is yes … for the most part. Here’s a look at how coverage breaks down by payer. The information here is a summary of data originally compiled in a KFF brief available here.

MEDICARE

Under Medicare Part B, diagnostic testing for COVID-19 will continue to be covered. Medicare participants will receive lab testing at no cost, and share in the costs for some test-related services. They will no longer be eligible to receive free at-home tests.

However, the situation is not as clear-cut for Medicare Advantage participants. In this case, whether there is cost sharing for diagnostic testing depends on the plan. All Medicare Advantage members are likely to undergo cost sharing for test-related services, with some plans willing to cover at-home test kits while others will not.

MEDICAID

Medicaid and its Children’s Health Insurance Program (CHIP) are required to fully cover all laboratory testing and test-related services for COVID-19 until September 30, 2024, when after this date, coverage for Medicaid and CHIP will be determined by state. States are generally expected to extend coverage for laboratory testing when ordered by a physician, yet for home tests and those not ordered by a healthcare professional, some states may continue paying while others may not. States also have the option to require cost-sharing for tests and related services.

PRIVATE INSURANCE

Following the end of the public health emergency phase, private payers typically began to treat COVID-19 testing like any other diagnostic test. Most private health plans include partial coverage, but participants can also expect some cost-sharing (at least for the associated doctor’s visit required to implement the ordering of the test). Depending on the general testing coverage terms, at-home tests may or may not be covered. In addition to cost-sharing requirements such as deductibles, copays, and coinsurance, insurers can institute coverage limitations, like requiring that testing be performed by in-network providers or capping the number of tests that may be covered for each insured person. For specifics on how your payer is treating COVID-19 testing post-PHE, visit the provider section of your payer’s website.

Recent updates on COVID-19 testing coverage from some of the largest private payers can be found here:
COVID-19 Testing & Treatment FAQs for Aetna Members
COVID-19 PHE ends on May 11, 2023 | UHCprovider.com
Coronavirus (COVID-19) Resource Center | Anthem

SAFETY NET

Patients without insurance are expected to pay for their own COVID-19 tests, whether at home or in the lab, but there are some safety net programs to assist. Free or low-cost tests may be made available through local health departments, and the CDC also provides free COVID-19 testing for uninsured people who have been exposed to the infection or who appear to have symptoms.

COVID-19 testing coverage has changed over the last year, but coverage and reimbursement are still available. To learn more about the COVID-19 testing solutions that may be a fit for your laboratory, visit Find Kits and Reagents by Disease Type | Diasorin or contact marketaccess@diasorin.com

*Infectious agent detection by nucleic acid (DNA or RNA); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus) (coronavirus disease [COVID-19]), amplified probe technique

Molecular Testing Offers Significant Advantages for Gastroenteritis Testing

By Rodney Sinchak, MLS(ASCP)

Incorporating norovirus detection for GI testing is key for diagnostic stewardship.

At Cape Cod Healthcare in Massachusetts, microbiology supervisor Patricia Phelan has been using a gastroenteritis panel assay that includes norovirus for the past four years to test patients and check for potential outbreaks in the hospital and the community.

Norovirus Testing: Importance and Benefits

Some labs do not routinely test for norovirus. Why? When it comes to diagnostic testing for patients with gastroenteritis, ordering physicians and clinical laboratories alike may suspect a bacterial cause based on the patient’s history, and may not always look for a virus. Because of the many overlapping manifestations of gastroenteritis, it can be difficult to distinguish between bacterial and viral causes.

While that approach is understandable, it’s also unfortunate. Learning that a patient’s gastrointestinal symptoms are caused by, say, norovirus is just as important for knowing how not to treat a patient. Positive viral results help clinicians avoid the unnecessary use of antibiotics, making these tests a key component in any diagnostic stewardship program.

Norovirus in particular is worthy of testing due to the magnitude of disease burden. In the U.S. alone, the pathogen causes 58% of foodborne illnesses and is responsible for an average of 109,000 hospitalizations and 465,000 emergency department visits each year. There are 2,500 norovirus outbreaks reported annually; these are often associated with communal settings such as cruise ships, schools, restaurants, and healthcare facilities. Outbreaks tend to peak between November and April, but norovirus infections can be acquired at any time.

According to the CDC, one in every five cases of acute gastroenteritis involving diarrhea and vomiting is triggered by norovirus. That’s a huge number of patients who might be given inappropriate antibiotics when they would do better with hydration and isolation protocols instead. Growing awareness of norovirus, as well as diagnostic stewardship mandates to use the right test for the right patient at the right time, has made it more important than ever to use diagnostic assays appropriately, delivering actionable information as quickly as possible to guide treatment and infection control measures.

VERIGENE® Enteric Pathogens Test: Enhancing Gastroenteritis Panel Testing

This is why Diasorin includes norovirus on our molecular gastroenteritis panel, the VERIGENE® Enteric Pathogens (EP) Test. Unlike other panel tests that include an overly broad range of pathogens, our targeted test was designed to comply with GI testing guidelines established by the Infectious Diseases Society of America. It helps to promote diagnostic stewardship by avoiding over-testing and is highly adaptable in today’s reimbursement landscape. The panel covers the five most common bacteria associated with gastroenteritis, as well as shiga-toxin detection, norovirus, and rotavirus. It allows physicians to consider the patient’s journey, symptoms, travel history, and demographics and select the most appropriate test for each case. The molecular test has excellent sensitivity and specificity, making it more reliable than stool cultures.

These attributes appealed to Patricia Phelan in Massachusetts. She chose the VERIGENE EP test “because of the ease of use of running the test compared to plating the stool to seven different plates,” she told us, while the infectious disease physicians at her facility “have been most impressed by the 2.5-hour turnaround time.” The VERIGENE EP test allowed her team to get results faster and avoid the send-out testing they previously needed for norovirus. It was a natural fit for Phelan’s team because they had already used the VERIGENE system for the molecular testing of positive blood cultures, which had received rave reviews from infectious disease physicians within the organization. The targeted EP test was also very attractive: “Other panels we looked at had too many esoteric tests in them to be practical and cost-effective,” Phelan said.

More and more laboratories are moving to molecular diagnostics for GI testing, avoiding the many drawbacks associated with conventional stool cultures. To learn more about how the VERIGENE EP panel can make a difference for your lab, visit us here.

Diagnostic Stewardship: A Primer

By Shannon Smith

Honing test selection can enable faster implementation of appropriate treatment, reduce costs, and support patient care in a range of settings

In the past decade, the practice of diagnostic stewardship has gained traction in the clinical laboratory community and broader healthcare field. Related to, yet distinct from antimicrobial stewardship, diagnostic stewardship aims to enable clinicians to provide the right test to the right patient at the right time to promote the right action. Given that the vast majority of healthcare decisions are now based on data produced by laboratory medicine, diagnostic stewardship ensures that tests are deployed strategically to offer patients the best possible outcomes.

Taking a More Focused Approach to Patient Care

Diagnostic Stewardship drives clinical action, typically through rapid-result tests that quickly give physicians the information they need to escalate or de-escalate antibiotics as soon as possible.  The goal is to avoid keeping patients on inappropriate therapy. Instead, critically ill patients—such as those suffering from bloodstream infections—may be shifted away from broad-spectrum antibiotics towards targeted therapies in order to rein in the development of antibiotic resistance. Deploying these tests appropriately offers additional benefits as well, including the ability to more easily track intervention fidelity, or how often a specific test changes the doctor’s choice of treatment, in order to continually hone the diagnostic stewardship effort.

While these features comprise important aspects within diagnostic stewardship, diagnostic stewardship goes beyond informing the correct antimicrobial treatment, maintaining a place in both in-patient and outpatient settings. By utilizing strategic testing algorithms, diagnostic stewardship programs can reduce unnecessary testing while ensuring that the tests selected to inform a patient’s particular treatment are the ones most likely to provide actionable and timely results. Appropriate usage of diagnostic tests can aid in reducing the cost burden for patients by tailoring test selections to reflect the patient’s needs, symptoms, and the seasonality rather than defaulting to a broader syndromic test.

Diagnostic Stewardship Takes Place Beyond the Lab

Even though clinical laboratories maintain the majority of responsibility for diagnostic stewardship programs, these programs require exceptional collaboration between the laboratory and clinical care partners. In some cases, close attention to patients’ symptoms may enable labs to skip certain tests or guide the selection of other tests. For example, there are specific situations where it is appropriate to test for C. difficile in patients with diarrhea; a good stewardship program will lead to effective testing algorithms that guide the usage of C. diff testing, such as for patients with a history of C. diff versus those without. Laboratories must work with front line physicians and other clinical staff to provide the right tests to help compliment treatment decisions based on patient history and presentation. This collaboration may help clinicians to interpret test results as accurately and holistically as possible.

Diasorin is leading the discussion on addressing your needs for diagnostic stewardship programs.  Our company is built on helping clinicians find the solutions they need from targeted tests to syndromic tests for multiple disease states.

Check out these resources to learn more:

Join Us in Raising Awareness about Antimicrobial Stewardship

Rapid molecular diagnostics make a difference for both antimicrobial resistance and C. difficile

It’s World Antimicrobial Awareness Week! A global campaign from the World Health Organization occurring November 18-24 is dedicated to raising awareness about the growing threat of antimicrobial resistance.

This challenge is no surprise to the life science community, where scientists and clinicians alike have been battling the effects of increasing pathogen resistance to our go-to therapies. Antibiotics in particular are increasingly ineffective; doctors around the world are now regularly reporting bacterial strains that are resistant to all known classes of treatment.

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Antimicrobial resistance threatens to erase decades of medical progress

Returning us to the days when bacterial infections were often fatal. Researchers have estimated that antibiotic resistance was responsible for nearly 1.3 million deaths in 2019 alone.

Fortunately, there is cause for hope. In a report published in 2019, the US Centers for Disease Control and Prevention found that antimicrobial stewardship programs have been successful over time, making a noticeable dent in the spread of antimicrobial resistance. Unfortunately, the COVID-19 pandemic and mass use of antibiotics for hospitalized patients appears to have reversed much of that progress. Still, the stewardship model has proven effective. Rolling out similar programs around the world could make a real difference in slowing the spread of drug-resistant pathogens.

One of the most important pillars of antimicrobial stewardship is the use of rapid molecular diagnostic tests that provide actionable information about a pathogen’s drug-resistance profile. Generating these results quickly makes it possible to deescalate patients from broad-spectrum antibiotics to more targeted treatments that are less likely to cause resistance.

We are proud to offer tests that are contributing to the fight against antimicrobial resistance

Clinical laboratories often use our VERIGENE® Bloodstream Infection assay portfolio to identify specific pathogens and their resistance profile in order to guide treatment selection. These assays generate results directly from positive blood culture bottles and produce actionable results in just three hours, slashing more than 30 hours from the traditional culture-based testing workflow and allowing doctors to adjust antibiotic use in a clinically relevant time frame.

Finding effective and responsible ways to avoid the long-term use of broad-spectrum antibiotics is also essential for reducing incidents of hospital-acquired infections. One notably common hospital-acquired infection is that caused by Clostridioides difficile (C. diff), which generates severe gastrointestinal distress. Overuse of heavy-duty antibiotics is one of the primary causes of C. diff spread; the infection is often acquired when patients’ healthy microbiomes have been wiped out, leaving them vulnerable to such pathogens.

While C. diff infection can be dangerous and potentially life-threatening, it is not well known in the general public. That’s why November is C. diff Awareness Month, a designation implemented several years ago by the CDC in an effort to help people better understand C. diff infection and how to prevent it.

Because C. diff infections can pose major consequences for patients, rapid detection and treatment are highly important. We have developed both the ARIES® C. difficile Assay, an in-vitro diagnostic that produces results in just two hours, and the Simplexa® C. difficile Direct Kit, which is designed for moderate-complexity CLIA labs and generates results in about an hour.

The Luminex team is committed to helping in the fight against antimicrobial resistance and related hospital-acquired infections such as C. diff. We encourage you to participate in awareness-raising efforts to promote better health for all.

Check out these resources to learn more:

For GI Testing, Targeted Panels Meet Today’s Reimbursement Criteria

The importance of diagnostic stewardship in gastrointestinal (GI) testing

Diagnostic stewardship involves more than choosing the correct diagnostic test and technology to deliver the needed clinical result. For clinical laboratory professionals, the objective of diagnostic stewardship is to ensure both the clinical and financial needs of the patient are met by decreasing unnecessary testing and overuse of antibiotics.

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Balancing patient needs and reimbursement realities in GI testing is essential to the clinical laboratory’s responsibility. For example, while large syndromic panel tests once appeared to be an optimal solution for some disease areas, payers’ reluctance (such as Medicare restrictions) to cover such broad tests has been a significant factor limiting their use.

Challenges of including C. diff in large syndromic panels

Thus, the importance of diagnostic stewardship in GI testing and reimbursement is particularly evident today, where GI testing historically has consisted of large syndromic panels that include C. difficile. Unfortunately, this approach can lead to over testing, since 20% of the population is asymptomatically colonized with C. diff, and so detecting this pathogen through broad panel testing often leads to overtreatment for patients whose GI symptoms are caused by something else entirely. Therefore, detecting these asymptomatic cases of C. diff is unhelpful for the patient clinically and financially, and professional organizations such as the Infectious Diseases Society of America (IDSA) recommend against C. diff testing altogether, unless warranted.

The benefits of targeted GI panel testing

Rather, clinicians prefer a more targeted testing option, where differential diagnosis can narrow potential pathogens as the cause of infection and thereby not result in costly over testing and overtreatment. When adapting to a changing reimbursement landscape, targeted GI panel testing as a solution becomes clear, as it shouldn’t be surprising that payers are opposed to reimbursing for these broad tests when they are not necessary. Furthermore, for typical patient populations, clinical laboratory teams are better served by choosing a more targeted GI panel test that does not include C. diff. One option is the VERIGENE® Enteric Pathogens (EP) Test, which meets GI testing guidelines from the IDSA for community-acquired diarrhea.

Choosing a more targeted panel can better serve most patient populations

Selecting a targeted GI panel to maximize reimbursement potential is more important today than ever. After three costly years of the COVID-19 pandemic, payers are exercising caution when it comes to overtesting, so clinical laboratory teams should expect increased scrutiny for any test that may be seen as unnecessary, with large syndromic panels at the top of that list. Medicare is already restricting the use of many targets to avoid overtesting, and other payers are likely to do the same.

Simplifying reimbursement and adapting to changes

Therefore, choosing a more targeted panel can be one of the more effective GI testing strategies for optimized reimbursement, and other single-target tests can be added as needed, such as C. diff testing in specific patients for whom that is appropriate. Starting small and having the opportunity to add on puts labs in a stronger position to meet today’s reimbursement criteria and avoid passing onerous costs onto their patients. This approach also makes it simpler for labs to navigate the frequent changes that occur in coverage determinations. After all, it’s easier and more cost-effective to add a target or two than to scrap an entire syndromic panel and start over.

Check out these resources to learn more:

During Cystic Fibrosis Awareness Month, We’re Celebrating the Benefits of Early Detection and Intervention

Multiplexed genomic testing can identify cystic fibrosis early and pave the way for lifelong benefits from early administration of therapies and other interventions

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Benefits of Early Detection and Intervention for Cystic Fibrosis

For many people, a cystic fibrosis (CF) diagnosis can be devastating—the rare genetic disorder affects breathing and digestion, potentially leading to lung damage, infections, and malnourishment. Because cystic fibrosis is progressive, symptoms tend to worsen over time. The life expectancy of people with cystic fibrosis is significantly shorter than average: babies born with the disorder in recent years are expected to live to around age 56.

Be that as it may, there has recently been tremendous progress in CF treatment. Not long ago, the typical life expectancy for patients with cystic fibrosis was in the 30s. Today, some patients are able to live decades longer than initially expected.

The Role of Multiplexed Genomic Testing in Cystic Fibrosis Detection

Much of that progress is due to new therapeutic options that have done wonders for patients’ prognosis. One such approach is gene therapy, which has been used in research studies as well as clinical trials to repair the aberrant CFTR gene responsible for the phenotype of patients with cystic fibrosis.

The month of May has been designated Cystic Fibrosis Awareness Month to help call attention to the challenges many people with this disorder face and to celebrate advancements in their care. Here at Luminex, we’re pleased to support and educate people about cystic fibrosis.

Cystic Fibrosis Carrier and Newborn Screening Guidelines

Luminex Dot Pattern

While therapies and other types of intervention are key to offering CF patients better health outcomes, getting patients on those therapies is only possible with a proper diagnosis. That’s why we are proud to offer three panel-based tests that utilize multiplexing to support accurate and early detection of cystic fibrosis by detecting the genetic variants associated with CF across a broad range of ethnicities.

Here’s a quick overview of our cystic fibrosis product offerings:

  • xTAG® CF39v2 Kit: Detects 39 mutations/variants that includes ACMG 23 and 16 additional mutations commonly found in the US population
  • xTAG® CF60v2 Kit: Detects 60 mutations/variants that includes ACMG 23 mutations and 37 North American most common (16 + 21) mutations
  • xTAG® CF71v2 Kit: Detects 71 mutations that includes ACMG 23 mutations and 48 European/North American most common (16 + 32) mutations

Recommendations for carrier screening and newborn screening for cystic fibrosis mutations have expanded over time. Most recently, the American College of Obstetricians and Gynecologists updated its guidelines to encourage carrier screening for cystic fibrosis for all women who are pregnant or considering becoming pregnant, regardless of ancestry or ethnicity. This was a much-needed expansion that overcame the limitations of previous ancestry-specific recommendations. In addition, the Cystic Fibrosis Foundation cites the importance of newborn screening to enable early detection and intervention.

We are proud to support clinical laboratory teams that provide cystic fibrosis screening or diagnosis to help give patients a better chance at a healthy life. Please help this community by spreading the word about Cystic Fibrosis Awareness Month!

To learn more about Luminex’s tests for cystic fibrosis, please check out these brochures:

CFTR Kits More CFTR Kits

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Pre-Operative COVID-19 Testing and the Case for Standalone vs. Paneled SARS-CoV-2 Assays

Standalone SARS-CoV-2 tests remain necessary for patient care and safety, while paneled tests support the broader diagnostic space

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Because hospitals and healthcare facilities continue to see patients for regular treatments, procedures, and surgeries, patient care has evolved to accommodate new standards and safety procedures to help slow the spread of COVID-19 and protect both patients and healthcare workers.

One of these safety measures includes pre-operative COVID-19 screening before surgery—a guideline issued by the Infectious Diseases Society of America (IDSA) early on in the pandemic. According to the IDSA, testing should be performed within 48–72 hours of the procedure, or as close to day-of as possible.

Also included in their COVID-19 testing guidelines, the IDSA recommends SARS-CoV-2 molecular testing even for asymptomatic individuals who are undergoing major or time-sensitive surgeries, since healthcare providers could use this information to guide PPE requirements. Even in elective surgeries, screening for COVID-19 is still recommended.

Pre-operative COVID-19 screening helps conserve resources

Many leading hospitals in the US have already adopted PCR-based SARS-CoV-2 testing prior to surgery whenever possible. In a publication from last year in NEJM Catalyst, physicians at the Virginia Mason Medical Center in Washington state reported that implementing universal patient screening before all medical procedures not only led to a safer environment for their staff, but also supported the conservation of N95 masks.

“As elective procedural care [resumes], screening for COVID-19 infection prior to all surgical and procedural care seems to be a viable model to provide care in a manner that is safe for both patients and staff,” the authors noted.

Standalone SARS-CoV-2 testing will continue to be crucial moving forward, even after vaccination rates start reducing infections in significant numbers. Because daily case numbers are still very high in many parts of the world, pre-operative COVID-19 screening can continue to help keep healthcare workers safe and can conserve resources.

Outside of the operating room, paneled tests support a more comprehensive approach to diagnosing respiratory illness

For patients with fever, cough, or other respiratory symptoms, diagnostic panels that include the SARS-CoV-2 target in addition to other respiratory pathogens remain important for correctly identifying the causative agent of a patient’s illness—especially since the symptoms of COVID-19 overlap with many of the symptoms of other respiratory illnesses, including influenza. Importantly, patient outcomes can depend on appropriate treatment strategies and in light of possible comorbidities, a definitive diagnosis is all the more important.

Since it appears that we may be dealing with COVID-19 for the foreseeable future, diagnostic tools will also need to evolve to meet the changing needs of the healthcare community and society at large. To support this need, we continue to advance the science behind our COVID-19 assays, providing targeted, paneled, and serology tests for a wide range of SARS-CoV-2 testing and research needs.

For more information about our SARS-CoV-2 offerings, or to learn more about how our COVID-19 solutions can support your lab, please visit our website.

Learn more about our SARS-CoV02 offerings here.

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Will Molecular Diagnostics Work with the New COVID-19 Variants?

In silico analysis demonstrates that Luminex SARS-CoV-2 assays can detect the current circulating variants

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Virus mutations are common and SARS-CoV-2 is no exception. As new variants have begun emerging, the focus around COVID-19 has shifted to these new mutations as scientists work to understand if they will be covered by existing tests and vaccines.

At the moment, four main variants have developed in various populations and are of significant concern to public health experts:

  • B.1.1.7, first identified in the UK
  • B.1.351, first detected in South Africa (also known as S.501Y.V2)
  • P.1, originally found in Brazil
  • L452R, one of five recurring mutations that constitute the B.1.429/CAL.20C variant

The most pressing concern from a diagnostics standpoint is whether current SARS-CoV-2 molecular tests accurately detect these variants, or if these modified viral genomes can evade detection or result in false-negatives.

It’s important to note that molecular tests developed for clinical use—that is, to aid clinicians in determining a patient’s diagnosis and choosing the optimal treatment strategy—don’t typically differentiate between COVID-19 variants when reporting results, and current treatment guidelines for COVID-19 patients do not depend on which variant a patient has. Variant identification is typically performed using non-diagnostic technologies, and is most helpful for epidemiological purposes.

Nonetheless, the concern about the appearance of COVID-19 mutations was one our R&D Team considered during assay development, so we designed the assay probes in our tests to detect highly conserved regions of the viral genome to ensure that new mutations would be unlikely to escape detection.

Additionally, our currently available tests make a positive call based on multiple gene interrogations. Even if one gene mutated enough to avoid being detected, our tests should still report a positive result based on the detection of other included gene targets.

Thorough, accurate diagnostics lead to better patient outcomes

Recently, we compared the SARS-CoV-2-specific oligonucleotide sequences used in our assays to the genetic sequences of the SARS-CoV-2 variants available as of late January. According to in silico analysis, all of our commercially available assays that detect SARS-CoV-2 contain probes that can detect all four variant viruses.

As of February 2021, we have received FDA emergency use authorization for several COVID-19 tests:

For more information about our latest COVID-19 offerings, including CE-IVD tests for use in labs outside of the US, check out our website.

Learn More About Our Latest COVID-19 Offerings.

(EUA) In Vitro Diagnostic Use Under Emergency Use Authorization. This test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories.

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How COVID-19 Is Changing Respiratory Testing Algorithms

As healthcare evolves through the pandemic, labs are strategically incorporating SARS-CoV-2 into routine testing

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The COVID-19 pandemic has shaped our lives for more than a year, and one thing is certain: SARS-CoV-2 isn’t going away anytime soon. In fact, with concerns over emerging strains and lingering questions about whether vaccinated individuals can still be contagious, accurate diagnostic test results will continue to be essential.

Clinical algorithms used for respiratory tests continue to evolve, especially after accommodating the continuous presence of COVID-19 for more than a year now. Additionally, since many symptoms of COVID-19 overlap with those seen in influenza, respiratory syncytial virus (RSV), and other respiratory illnesses, testing has been one of the most challenging aspects of the pandemic. Influenza in particular shares several symptoms also seen in COVID-19, including fever, cough, difficulty breathing, fatigue, and more—all with varying degrees of severity.

Although there are other important differences between COVID-19 and other respiratory illnesses, testing is the best way to determine a diagnosis. Since the beginning of the outbreak, lab teams have had a need for reliable respiratory panels that include not only influenza A/B and RSV, but also SARS-CoV-2.

Respiratory panels offer several benefits compared to single-target tests

Beyond diagnostic confirmation, there are benefits to using a test that combines SARS-CoV-2 detection with testing for other respiratory infections. Running a single combination test is more comfortable for the patient since only one sample is needed, and with one streamlined workflow to get results for multiple targets, it ends up being more efficient for the lab as well, saving both time and resources.

Outside of flu season, it will still be important to include SARS-CoV-2 in regular respiratory infection testing. Ideally, the virus would be added to all standard respiratory panels used by clinical labs throughout the year, as well as to small, targeted panels for specific seasons and for vulnerable patient populations.

Of course, standalone testing for SARS-CoV-2 will continue to be important as well—particularly for back-to-work and back-to-school testing, before surgical procedures, and for other routine screening not based on specific respiratory symptoms.

With the ongoing increased need for flexible and comprehensive diagnostic testing tools, we’re working hard to help ensure clinical labs have options for managing SARS-CoV-2 testing in the long term. For targeted SARS-CoV-2 testing, we developed the ® Respiratory Pathogen Panel + SARS-CoV-2″ href=”/nxtag-respiratory-pathogen-panel-sars-cov-2/”>NxTAG® Respiratory Pathogen Panel + SARS-CoV-2 (EUA, CE-IVD) and the ® SARS-CoV-2 Antibody Assay” href=”/xmap-sars-cov-2-antibody-testing/#overview”>xMAP® SARS-CoV-2 Antibody Assay (EUA) enables the identification of antibodies against SARS-CoV-2 in serum. With additional plans to continue adding the SARS-CoV-2 target to our existing assays, it’s safe to say whatever your testing needs are, we have a solution for you.

For more information about our latest COVID-19 offerings, check out our website.

Learn More About Our Latest COVID-19 Offerings.

(EUA) In Vitro Diagnostic Use Under Emergency Use Authorization. This test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories.
(CE-IVD) For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions.

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