Amid Growing Measles Outbreaks, Clinical Labs on Alert to Increase Testing Capacity

By Ayaz Majid, PhD

With a surge of cases reported across the US, and decreasing vaccination rates, the measles virus is making a worrying comeback in the US

The current measles outbreak first reported in Texas in January of 2025 has now spread to 18 US jurisdictions. As of May 2025, over 1,000 confirmed cases have been reported, with three associated deaths. For context, there were 285 measles cases reported in the US during all of 2024, and some public health experts fear that the true case count in the ongoing outbreaks could be even higher.

When it comes to measles, protection means one thing: vaccination

 

Sporadic measles cases aren’t uncommon in the US, but the recent outbreaks have led to the country’s first measles-related deaths in over a decade. Globally, measles is also on the rise, prompting the Centers for Disease Control and Prevention (CDC) to issue alerts advising travelers to review their vaccination status before visiting many countries. The measles virus (rubeola), is highly contagious — according to the CDC, each person who has measles could infect up to 90% of people nearby if they don’t have protection. Children are particularly at higher risk, where one-third of cases were seen in kids younger than 5 years old, and nearly three-quarters have occurred in individuals 19 years of age or younger.

When it comes to measles, protection means vaccination. According to the CDC, the measles, mumps, and rubella (MMR) vaccine offers the best protection against measles, which provides long-lasting immunity to all strains of the virus. In the recent Texas outbreak, 95% of cases occurred in people who were unvaccinated or whose vaccination status was unknown, while only 2% of cases were reported in those who were fully vaccinated. Although more than 90% of children in the US receive both recommended doses of the MMR vaccine, the vaccination rates are significantly lower in the west Texas area where the outbreak originated. Generally, herd immunity is achieved with vaccination levels at 95%.

Diagnostic testing is highly recommended for those exhibiting measles symptoms

 

The CDC expresses that decreased vaccination rates will prime more communities for future outbreaks. Subsequently, clinical labs must be prepared to run measle testing. The CDC recommends serology testing using blood specimens, and RT-PCR testing in nasopharyngeal or throat swabs ideally within first 3 days of rash onset. Additionally, urine samples may also be collected for RT-PCR within 7 days of rash onset. Testing is most sensitive within three days of the onset of a rash, but the measles virus can still be detected up to 10 days after symptoms begin. Diagnostic testing is highly recommended for patients with measles-associated symptoms who live in or have recently traveled to a region with a measles outbreak, as well as for individuals without immunity, such as the immunocompromised and those who are unvaccinated.

As the diagnostic specialist, Diasorin ensures clinical labs have unique, high-quality products. The combination of our continuously expanding menu of IVD assays on the LIAISON® MDX. We also offer our extensive menu of Analyte Specific Reagents (ASRs) to support laboratories to meet the needs of emerging infectious disease outbreaks with molecular testing solutions.

 

To learn more about Diasorin’s molecular offerings and our new measles primer pair offering, please visit Primer Pairs | Analyte Specific Reagents (ASRs) | Diasorin.

Molecular Testing for Candida auris can Improve Infection Prevention Efforts

By Chiara Seletti

Testing patients suspected of being colonized with this fungal pathogen can help prevent potentially deadly outbreaks in healthcare settings

Since it was first identified in 2009, Candida auris (C. auris) is now regarded as a severe threat to public health. The fungus is a significant pathogen possessing a deep reservoir of drug-resistance mechanisms. C. auris isolates can be multidrug-resistant, with some isolates showing pan resistance. Alarmingly, 90% of C. auris isolates are resistant to at least one of four drug classes.

The presence of C. auris poses a risk to many patients in healthcare settings

The Centers for Disease Control and Prevention classified C. auris as an urgent microbial resistance threat, noting the alarming rate at which it has spread in healthcare facilities. Additionally, the World Health Organization categorized it as a critical priority pathogen.

This challenging pathogen is difficult to eradicate, as it persists on environmental surfaces for as long as three months and cannot be removed with standard disinfectants. In hospitals and other healthcare facilities, the presence of C. auris can be a risk to many patients.

Colonization poses a significant risk for spreading infection, and studies suggest that 10% of colonized patients are susceptible to developing an invasive infection. Infections caused by C. auris can be particularly severe, leading to bloodstream infections, wound infections, and ear infections. The mortality rate from bloodstream infections is alarmingly high, reaching up to 60%, especially among vulnerable patients, such as those who are immunocompromised.

To reduce the risk of spread, rapid identification of colonized patients is key

For the best chance of preventing C. auris outbreaks in healthcare settings, infection prevention experts recommend testing anyone with risk factors associated with colonization with this pathogen. Patients who test positive can then be isolated and cared for with proper infection control measures to reduce the risk of spreading C. auris to other patients in the facility.

To meet this need, Diasorin developed the Simplexa® C. auris Direct assay for the in vitro qualitative detection of C. auris DNA directly from a composite swab of bilateral axilla/groin from patients suspected of colonization. The test runs on the LIAISON® MDX platform, generating results in less than two hours with excellent clinical performance —achieving 94.8% sensitivity and 98.7% specificity in clinical trials. The assay has broad coverage to detect the known C. auris clades that have been detected globally.

The Simplexa® C. auris Direct assay: your solution for rapid identification of colonized patients

In 2024, the Simplexa® C. auris Direct assay was granted De Novo authorization from the US Food and Drug Administration. Now, it has also received CE-IVDR marking, allowing it to be used as a clinical test in all countries accepting the CE mark.

The Simplexa® C. auris Direct assay enables rapid identification of colonized patients, which ultimately empowers healthcare teams to manage this dangerous pathogen more effectively through infection control and prevention efforts, thereby achieving better patient outcomes.

For more information on the Simplexa® C. auris Direct assay:

  • Watch the video, from IDWeek 2024, where Dr. Berry elaborates on C. auris and reviews the clinical and analytical data of the Simplexa® C. auris Direct assay.
  • Click here to request additional information

CDC’s Recommendation to Accelerate the Subtyping of Positive Influenza A Respiratory Specimens from Hospitalized Patients

By Bridget Parsons

What laboratories need to know in light of recent avian influenza cases

The Centers for Disease Control and Prevention (CDC) issued a key recommendation on January 16, 2025 for healthcare providers to expedite the subtyping of positive influenza A respiratory specimens from hospitalized patients.1 This guidance comes at a critical time, as a result of the recent cases of highly pathogenic avian influenza A (H5N1) raising significant public health concerns. While the CDC’s recommendation is more crucial than ever for managing influenza in patients, understanding your testing options, such as the LIAISON PLEX® Respiratory Flex Assay, can help you stay aligned with evolving testing guidelines in the fight against this pathogen.

Why subtyping influenza A is critical right now

Influenza A is the primary driver of seasonal influenza outbreaks, but it’s also the most likely to mutate into novel strains that could pose significant public health risks. The avian influenza A (H5N1) has been a cause of particular concern over recent months due to an uptick in human infections. This strain, while not yet a widespread threat to humans, has the potential to mutate rapidly, which is why the CDC’s recommendation for subtyping influenza A respiratory specimens has never been more critical.

  1. Distinguishing between seasonal influenza and avian influenza strains
    By subtyping positive influenza A specimens, you can distinguish between seasonal strain (H1N1 or H3N2) or a more concerning strain like avian influenza A (H5N1). Avian influenza primarily spreads from birds to humans, often through direct contact or exposure to contaminated environments. Furthermore, if the patient has a known history of poultry exposure, early identification of H5N1 is critical to ensuring appropriate patient management, including stricter isolation measures and reporting to public health authorities.
  2. Tracking emerging threats
    While seasonal influenza strains follow a predictable pattern of evolution each year, avian influenza presents a higher level of uncertainty. Subtyping tests allow monitoring of whether H5N1 or similar strains are becoming more prevalent in your community and can provide early warning signs of shifts in the virus’s behavior, allowing health authorities to respond quickly.
  3. Facilitating appropriate public health responses
    Subtyping for H1 and H3 influenza A cases helps not only with individual patient management but also with the larger public health response. Early detection of avian influenza allows public health officials to take prompt action, such as issuing targeted advisories, deploying appropriate antivirals, and tracing contacts of infected individuals. By incorporating subtyping into your testing strategy, you’re helping to contribute critical data that allows for a more nuanced, informed public health response.

Preparing your laboratory

Not all influenza tests can provide subtyping results directly. In many cases, subtyping may require additional resources or a longer processing time, which could delay diagnosis and treatment. Ensure your laboratory is equipped to handle subtyping and prioritization of timely results for positive influenza A respiratory samples, especially in cases where avian influenza is suspected.

Diasorin’s newest system, the LIAISON PLEX®, is uniquely designed to help laboratories meet the changing demands of respiratory testing. The LIAISON PLEX® Respiratory Flex Assay provides a selection of 19 respiratory pathogens but allows you to create customized patient- and season-specific mini panels, unlike static syndromic panels. You can easily add or remove H1 and H3 from a mini panel as seasonal or outbreak demands occur.

Moreover, LIAISON PLEX® Flex Software allows users to instantly append additional targets after a run completion if desired. So, if a non-subtyping custom panel returns a positive influenza A result, users could easily choose to add H1 and H3, without additional consumables or testing time.

To learn more about the LIAISON PLEX® System and Assays that may be a fit for your laboratory, visit our website or contact us.

A vital step in protecting public health

The CDC’s recommendation to subtype positive influenza A respiratory samples is an important step in maintaining vigilance during influenza season, particularly in light of the potential threats posed by avian influenza A (H5N1). By identifying and differentiating between seasonal and more concerning strains like H5N1, you can help protect your patients, your community, and ultimately contribute to the global fight against influenza.

 

1 https://www.cdc.gov/han/2025/han00520.html

Amid Pertussis Surge, Appropriate Bordetella Testing Options Are Essential For Better Outcomes

By Ed Janoszewski

Clinical labs may need a targeted or panel test depending on the situation

They call it the hundred-day cough. After years of declining infection rates, pertussis ­— better known as whooping cough — is surging. Last spring, health officials in Europe sounded the alarm as tens of thousands of cases were detected, with the worst infections and mortality rates seen in infants. By summer, public health agencies warned about similar spikes in Latin American countries including Brazil, Peru, and Mexico. In the US late last year, the Centers for Disease Control and Prevention (CDC) issued an alert as pertussis levels soared to six times those seen at the same time the year before. Year-end reports documented about 7,000 cases in the US in 2023, and more than 35,000 cases in 2024.

There’s a perfect storm of factors contributing to this trend. Like most respiratory infections, pertussis spread less during the COVID-19 pandemic as people adopted precautions such as masking, keeping socially distant, and staying home when sick. However, like its respiratory counterparts, pertussis has rebounded as people reverted to their normal behavior.

Additionally, while pertussis vaccination is widely recommended as the best way to prevent illness, broader fears and resistance to vaccines have reduced compliance. The pandemic also disrupted routine vaccination schedules, leaving some people — especially children — with less protection than they might otherwise have had. For those vaccinated, immunity can wane over time, leading to increased susceptibility to whooping cough. Currently, the CDC does not have a recommendation for pertussis vaccine booster doses to restore immune protection in older adults.

Furthermore, doctors are aware of whooping cough’s rise in cases and have increased their testing for the underlying main pathogen, Bordetella pertussis. More frequent testing is making it possible to detect and report cases that might have been missed otherwise.

Bordetella testing

Bordetella testing is essential for optimal patient outcomes with this highly transmissible infection. Identifying pertussis cases can help mitigate local outbreaks, for example, by keeping sick children home from school when they are most contagious, and it also allows physicians to select the most appropriate antibiotics for faster treatment. A history of pertussis in children can also contribute to a potential risk of developing asthma, making it important for patients to know whether their illness was pertussis or some other pathogen.

For clinical laboratory teams, choosing the right Bordetella test can be a challenge. Accuracy is essential; in addition to needing reliable information for patient care, labs are also required to report Bordetella cases to the CDC and other public health departments. Another crucial factor is timing. Acute pertussis presents similarly to common respiratory infections, yet as the disease progresses, the telltale cough differentiates from other respiratory patients. For that reason, using broad respiratory panels is often not in line with diagnostic stewardship initiatives. Instead, a targeted test for Bordetella alone or a flexible panel that allows for the choice of specific targets should be used to confirm the diagnosis once patients have developed symptoms unique to whooping cough. There are some cases — for example, when extremely ill pediatric patients with symptoms of respiratory illness are admitted to a hospital — where using a broad testing panel is appropriate.

The Diasorin Solution

At Diasorin, we are proud to be the only test provider that offers both a targeted Bordetella test and a flexible respiratory panel that includes Bordetella, offering laboratories and their physicians the appropriate Bordetella testing solution based on the clinical situation.

The Simplexa® Bordetella Direct test is a well-established real-time qualitative PCR assay that allows users to detect and differentiate Bordetella pertussis and Bordetella parapertussis using the widely installed LIAISON® MDX instrument. An excellent option for an outbreak scenario where pertussis is known to be spreading in a community, this targeted diagnostic assay is ideal for confirmation testing, which can help physicians choose the most appropriate antibiotics to reduce severity and shorten the duration of illness. This is especially true in cases where healthcare professionals delay treatment until they’re certain whether the pathogen is viral or bacterial.

When clinical lab teams desire flexibility in testing, they can deploy the recently commercialized LIAISON PLEX® Respiratory Flex Assay, which includes Bordetella pertussis and Bordetella parapertussis, as well as Bordetella holmesii, in addition to several viruses and bacteria that are common culprits in respiratory infections. With the Flex testing model, users can report results for all these pathogens or choose a subset that’s most appropriate for each case, paying only for the results reported.

Given the significant rise in pertussis cases, many laboratories that have not had to test for this pathogen need to consider adding it to their test menu. Labs that already have either the LIAISON® MDX instrument or the LIAISON PLEX® System can advocate to stem the spread of this surging pathogen by easily incorporating Bordetella testing to ensure reliable detection and more customized care for each patient.

Check out these resources to learn more:

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: