“Smarter Diagnostics” with a Flex™ Respiratory Testing Approach

By Diasorin

At Holland Hospital, the clinical lab team achieved more appropriate testing, along with six-figure cost savings, by implementing a customizable assay for respiratory infections

At the annual meeting of the Pan American Society for Clinical Virology (PASCV) earlier this year, there was a very informative presentation from Nicholas Decker, Director of Laboratory Services at Holland Hospital in Michigan, about his experience implementing a Flex™ Testing approach for respiratory infections. The talk offered useful highlights for clinical laboratory professionals wondering whether this model would make a difference in their healthcare systems. We’ve summarized the key points here, but the entire presentation is well worth watching.

A Challenging Landscape

A more flexible testing option is needed due to growing challenges facing most clinical laboratories. Decker pointed to rising costs, reimbursement issues, and staff shortages as common pain points—and noted that even amid all these other problems, his lab’s test menu, testing volume, and testing complexity have all been increasing. “We need solutions now, and not in five years,” he said. “We have to become more responsible with our resources.”

Another challenge has been the widespread use of broad syndromic testing panels, which are often employed even when a large panel is not clinically appropriate. Overutilization of these panels has driven up costs and made it harder to implement effective diagnostic stewardship practices.

What is Flex Testing?

Diasorin offers the unique Flex Testing model to help clinical teams address these issues. It delivers the best of both worlds: the test covers the same diversity of pathogens as a broad syndromic panel, but users get to choose which targets to report, and they pay only for the results reported out. This allows laboratories to create custom mini panels from subsets of targets on the larger panel, leading to more appropriate testing and reducing overall costs. But in cases where the full list of targets is warranted, all results are available and ready to report in the same rapid turnaround time.

At Holland Hospital, Decker and his team were early adopters of the FDA-cleared LIAISON PLEX® Respiratory Flex Assay, which includes a total of 19 bacterial and viral targets associated with respiratory infections. “I have yet to find a case where this didn’t help us out,” he told meeting attendees. The ability to create custom mini panels is helpful for responding to local epidemiological changes, the flux of seasonality, and shifting reimbursement coverage.

In addition to the benefits of a flexible testing model, he also pointed to other beneficial attributes of the assay: room temperature storage, scalability, random access testing, a sample-to-answer workflow, and a handy touchscreen interface.

Holland’s Approach: Impressive Savings

In Decker’s lab, the team was eager to use a more customizable option—but also wary of creating a more difficult or complicated protocol. “We want to take care of all of our patients using the same process, the same workflow,” he said.

With that in mind, the team stratified their patient population into two broad categories: inpatients, for whom the cost of each test is less important due to diagnosis related group (DRG) usage and who tend to be sick enough to require a large syndromic panel; and outpatients, for whom test prices play a significant role and are generally less acutely ill and more likely to benefit from targeted testing.

Decker’s lab began Flex Testing last fall, with ambitious goals for how much money the customizable assay would save over time. “We projected six figures’ worth of financial improvement to the bottom line just by containing the overuse of 20-plus target panels,” he said at the conference. “I’m proud to share that we not only achieved that—we yielded a 10% higher return than we even budgeted.”

The laboratory team defined mini panels both by clinical utility and reimbursement considerations, leveraging guidance from a white paper, now published as a peer-reviewed article by Gonzalez et al., 2025 in The Journal of Molecular Diagnostics (JMD). Decker also stressed the importance of planning ahead; his team wanted the ability to redesign panels as needs change over time, so they worked carefully within their LIS to make sure that would be possible. They honed algorithms to ensure that it was clear to everyone when to reflex to the full syndromic panel if all targets on a mini panel returned negative results.

“Customizable testing supports smarter diagnostics,” Decker concluded. “Smarter diagnostics makes us all look better.”

Learn more about the LIAISON PLEX Respiratory Flex Assay.

A Flexible Model Is Necessary for Today’s Respiratory Testing

By Gabby Mora

Two new whitepapers highlight the value of customizable respiratory testing in reducing costs, increasing reimbursement coverage, adhering to clinical guidelines, and meeting diagnostic stewardship goals

In the world of respiratory testing, uncertainty is a given. How bad will the next flu season be? Which pathogens will circulate? How much will my lab have to spend on testing? There is no way to eliminate uncertainty from respiratory testing, but a strategic selection of a testing platform — such as the highly flexible LIAISON PLEX® System — can help navigate and respond to that uncertainty.

Todays respiratory testing challenges

Take, for example, the dynamic reimbursement landscape. Clinical laboratories may find it easiest to run syndromic panels for all respiratory infection cases. However, syndromic panels are not necessarily covered by insurance for all patients — and these laboratories may find much more uncertainty in reimbursement than labs that adhere to recommended clinical guidelines. In many cases, large-scale syndromic panels are not a cost-effective solution.

Another consideration arises from diagnostic stewardship efforts. In today’s healthcare environment, there is a growing focus on the appropriate use of syndromic molecular panels. To ensure that patients get the right test at the right time, testing algorithms that point to the most appropriate test targets based on patient demographics, seasonality, geographical location, outbreaks, and immune status must be established.

In both cases, flexibility in testing offers substantial benefits. A customizable molecular panel can play an important role as healthcare systems move toward value-based reimbursement programs and try to rein in rapidly increasing costs.

Creating custom panels based on appropriate clinical guidelines, tailored to seasonality and unique patient populations

Diasorin has developed a uniquely flexible approach to meet this growing need. The LIAISON PLEX® System offers the ease of use of a single assay that provides the flexibility to match diagnostic stewardship goals. Clinicians and laboratorians can create custom panels based on appropriate clinical guidelines, tailored to seasonality and unique patient populations. This option replaces the need for other syndromic panels, offering the ability to lower costs by running targeted panels with fewer targets while enabling users to opt for the full panel when needed. Flexible testing empowers providers to make diagnostic decisions based on their clinical expertise and assessment of the patient, rather than being limited by manufacturer-defined test panels.

Overcoming the limitations of one-size-fits-all testing with the LIAISON PLEX® Respiratory Flex Assay

Diasorin’s FDA-cleared LIAISON PLEX® Respiratory Flex Assay brings this flexible model to respiratory testing, helping labs overcome the limitations of one-size-fits-all testing. The assay includes 14 viral and 5 bacterial targets, allowing users to offer the full syndromic panel when clinically appropriate or select subsets of those targets to create their own mini-panels for more targeted testing.

Here’s how it works: clinical laboratories implement and verify a single syndromic panel for respiratory infections that covers the most common viral and bacterial targets. Then, for each sample, users can select which targets they want to analyze, and test cost is based on the number of targets reported. Labs can also group selected targets into predefined custom panels (for example, a panel focused on the most likely pathogens in pediatric patients), which can then be used repeatedly for similar cases.

In addition to the ability to select custom sub-panels from the broader panel, the other value in Flex™ Testing resides in what occurs after initial testing. If a custom panel yields negative results, labs can report additional targets from the full panel without needing to run the assay again or collect another sample from the patient. The final cost is determined by the total number of targets reported, allowing labs to closely manage operational expenses while maintaining diagnostic efficiency.

Witness the real-world benefits of a flexible testing model in our two white papers

The Diasorin team has published two educational whitepapers focused on the real-world benefits of a flexible testing model. Check them out:

Diagnostic Stewardship for Multiplex Respiratory Testing: Flexibility Is the Name of the Game

By Kaisha Gonzalez, PhD and Giulia Amicarelli, PhD

This whitepaper examines data from more than 1,500 samples tested in a single recent respiratory disease season, with useful findings about pathogen prevalence in different patient demographic groups, showing that 85% to 95% of positivity originates from just seven targets.

 

For Respiratory Testing, a Flexible Model Helps Laboratories Address the Reimbursement Responsibility

By Stephanie Ibbotson and Bridget Parsons

This whitepaper delves into reimbursement considerations, diagnostic stewardship, ongoing clinical challenges associated with respiratory testing, and potential cost savings from adapting to a flexible testing approach.

 

For information about the LIAISON PLEX® and its many features, including its unparalleled flexibility, please visit our website to learn more:

LIAISON PLEX® | Diasorin

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.

Tick-Borne Diseases are a Growing Global Concern: Bridging the Gap in Clinical Testing and Surveillance

By Chiara Seletti

As ticks spread to new regions and remain active longer, the diseases they cause have become a significant challenge for public health

Nothing spoils the prospect of a beautiful walk through the woods quite as thoroughly as the threat of ticks. Whether tending to your garden, walking the dog, or playing soccer in the park, routine activities in the warmer months are putting us at increased risk of encountering these pathogen-laden bugs.

Ticks are most active in the spring and summer, making this time of year the most likely for people to contract a tick-borne disease. Studies have shown that climate change is influencing tick populations and the pathogens they carry, and as warmer temperatures and wildlife migration expand, so are tick habitats and their active periods.1

With rapid results from molecular diagnostic tests, clinicians can effectively provide the right treatment to patients when it is most needed

 

This trend means that more healthcare providers will treat patients with a tick-borne disease, putting pressure on clinical laboratory teams to improve and implement appropriate tests to identify these cases as quickly as possible. This is made even more challenging by the overlapping and non-specific symptoms characteristic of many tick-borne diseases. With rapid lab results delivered by molecular diagnostic tests, clinicians can best provide the right treatment to patients during the period it will be most effective. Without prompt diagnosis and treatment, some tick-borne diseases can lead to serious health complications, including chronic conditions, long-term disability, or even life-threatening outcomes.1

Examples of common and emerging tick-borne diseases

Ticks carry a broad range of pathogens, including bacteria, viruses, and parasites, which can be transmitted to humans and animals through a tick bite. Here are some examples of common and emerging tick-borne diseases:

Lyme disease

Perhaps the best-known of these infections is Lyme disease, which is transmitted by black-legged ticks carrying Borrelia burgdorferi. This is now the most common tick-borne disease in North America, with more than 300,000 cases diagnosed each year in the US, and the incidence continues to rise.1 Without proper treatment, patients can be affected by long-term issues related to the heart, nervous system, and joints.

Anaplasmosis

Another disease carried by black-legged ticks is anaplasmosis, caused by Anaplasma phagocytophilum. Some 4,000 to 6,000 cases are reported annually in the US, and disease prevalence is increasing. Unlike the bull’s-eye rash associated with many cases of Lyme disease, the symptoms of anaplasmosis are generally non-specific, leading to a high risk of missed diagnosis.

Babesiosis

Less prevalent than Lyme disease or anaplasmosis, the incidence of babesiosis is rising in areas where Lyme disease is common. It can be spread by any tick found on deer, though its primary vector is also the black-legged variety. Babesiosis is caused by Babesia species, and approximately 1,000 to 2,000 cases are reported annually in the US, particularly among immunocompromised people.

Borrelia miyamotoi disease

Another emerging threat, the Borrelia miyamotoi bacterium is a recently recognized pathogen carried by ticks. Initially considered less serious, this tick-borne disease has quickly grown into a major health concern in regions with large tick populations, with infections rising due to environmental changes and human activities that affect tick habitats. Early, accurate diagnosis is essential for containing this pathogen.

Laboratory testing can help address the growing prevalence of tick-borne diseases through early diagnosis and management. The speed and accuracy of tests are better than ever thanks to advances in PCR-based molecular diagnostic tools. For example, newly developed primers for Borrelia miyamotoi have enabled labs to identify this emerging pathogen more efficiently, contributing to better patient outcomes.

Ehrlichiosis

Additionally, another often overlooked but potentially serious infection is Ehrlichiosis, which is caused by a group of bacteria in the genus Ehrlichia. Ehrlichiosis is transmitted primarily through the bite of the lone star tick (Amblyomma americanum), though other tick species can also serve as vectors. This disease affects both humans and animals, especially dogs. While treatable with antibiotics, it can escalate quickly and become severe, or even life-threatening, if not recognized and managed early.

Older adults, individuals with weakened immune systems, and those who delay seeking medical treatment are at higher risk for developing serious illness. That’s why early detection and prompt treatment are so important. Molecular testing, performed with PCR, can detect the presence of Ehrlichia DNA in the blood early in the course of illness. This not only confirms the infection but also helps prevent unnecessary delays in treatment.

As tick populations continue to spread, early and prompt diagnosis through molecular testing is critical

As tick populations spread into new regions, the threat of tick-borne diseases is growing rapidly. Early diagnosis through molecular testing is critical — it enables timely treatment, reduces the risk of severe complications, and helps control outbreaks. When paired with greater awareness and preventive action, early detection plays a key role in reducing the health impact of these dangerous pathogens.

Diasorin is a trusted partner in the detection and management of tick-borne diseases, offering advanced diagnostic solutions that empower healthcare providers to deliver timely, accurate diagnoses and ensure effective treatment for their patients. Visit our website to learn more about our offerings.

Reference:
1. Ticks | Ticks | CDC

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.