Colorectal cancer (CRC) is a leading cause of death for both men and women – and is projected to be responsible 50,630 deaths in 2018. Odds of developing CRC are about 1 in 20. In most cases, it grows slowly – with few if any symptoms in the beginning. Early detection, however, can make a significant difference in helping patients survive. For example, patients diagnosed with Stage 1 have a far greater chance of survival than those diagnosed at Stage 4.
Effective Screening is a Big Part of Saving Patients’ Lives
New studies suggest that starting at age 45, adults without symptoms should have routine screenings for CRC and adenomatous polyps. The guidelines vary when it comes to how frequently someone should be screened, what age they can stop screenings, and the best method to use. Factors that may raise the risk level are family history, diet, and smoking.
Old Screening Methods Give Way to New Tests
Traditional methods have limitations and issues involving sensitivity, specificity, ease of use, and compliance.
While colonoscopy is the most common screening method, it is not available in all clinical settings, and many patients find the test preparation and invasive nature of the test itself so undesirable that they refuse to undergo it.
Fortunately, alternate screening methods can be used to screen for CRC, like those that detect the presence of fecal occult blood (FOB) in the patient’s stool (such as the Guaiac Fecal Occult Blood Test). However, it does have significant dietary restrictions in order to get accurate results – which can lead to poor patient compliance.
One good option is high-sensitivity immunochemical tests, like the Fecal Immunochemical Test (FIT) – also known as Immunochemical Fecal Occult Blood Test (IFOBT). Designed to detect human hemoglobin in a patient’s stool, these tests can be given annually to patients with an average risk level. When combined with adequate follow-up, they provide similar reductions in incidence and mortality as a colonoscopy.
Choosing What’s Right for Your Patient
To decide the right CRC diagnostic method for your patient, the 3 points to consider are:
- Accuracy – being sure the patient gets the right diagnosis
- Patient Compliance – ensuring the specimen is easy to collect and there are little or no dietary restrictions
- Cost – making sure the screening is affordable and cost-effective
FIT/iFOB Test – The Bottom Line
In a study that compared it to gFOBT, fecal DNA, flexible sigmoidoscopy and colonoscopy, the FIT/iFOB was the most effective and least costly. Looking at numbers, one study demonstrated that, during the lifetime of 100,000 people with average risk, FIT/iFOB testing once a year would drastically lower cancer incidence and death rates.
With its combination of accuracy, cost-effectiveness and better patient compliance (results in 5-10 minutes with less than 1 minute of hands-on time), the FIT/iFOB is a CRC screening method that can effectively help detect cancer and save lives.
In a post on Using Point-of-Care Testing in the Physician’s Office, we discussed the advantages of performing routine lab testing in a Physician Office Lab (POL), rather than sending out samples to centralized laboratories.
Performing lab tests in your office helps avoid one of the few still-unaddressed-inefficiencies in patient healthcare: the sending out of samples and then waiting for results to come in.
But for many doctor’s offices there is concern and uncertainty surrounding the time, costs and process of making the switch to in-house moderately complex testing.
Many physician office Point-of-Care laboratories begin in-house testing with CLIA-waived tests, or tests that are considered simple tests with a low risk of an incorrect result. At some point, however, a physician’s office lab may decide to upgrade their testing to offer additional in-house assays for the clear reasons outlined in our earlier post on Point-of-Care Testing in POLs.
Understanding Test Complexity
CLIA (Clinical Laboratory Improvement Amendments, a law administering the certification & oversight of clinical laboratory testing) organizes tests into one of three categories: Waived, Moderate Complexity and High Complexity. Each category has its own testing site requirements, which grow more stringent at higher levels.
When categorizing an assay, the FDA looks at:
- Whether interpretation of results and ‘independent judgment’ will be needed
- How much quality control and calibration of lab instruments will be required
- The amount of training the test will demand to ensure successful instrument operation
- The complexity of the test procedures and methods.
In general, the tests a physician’s office sends out to a hospital, central or reference lab are typically considered Moderately Complex.
Deciding to Upgrade to Moderately Complex Testing
The decision to offer moderately complex tests in-house is often driven by one or both of the following factors:
- A test is currently sent out, necessitating an additional patient visit, a delay in treatment, higher costs and more healthcare provider & patient time.
- Certain tests are high volume, and offer revenue-generating opportunities for the physician’s practice.
Whatever the reason – and there are many – upgrading to moderately complex testing in-house can offer tremendous benefits, from better & faster patient care and additional revenues to patient & treating physician peace of mind. Many physician owned labs see this as an excellent trade-off for the time and money that may be needed to upgrade from a waived to a moderately complex lab.
Not As Complex As You Might Believe
The complexity of upgrading to a moderately-complex lab is often overstated. In fact, when properly-implemented, becoming a Moderately Complex Lab isn’t as difficult as physician offices may think and the requirements tend to be less onerous than physicians likely believe.
The decision to upgrade, however, will come down to SWOT and cost/benefit analyses which should be conducted to determine if the physician’s office can support the lab.
Labs wanting to upgrade their testing capabilities have some justified concerns:
- Is it cost-effective or revenue-generating?
- Is it feasible from a workflow and work space perspective?
- Can I efficiently (and with as little fuss as possible) meet the requirements of this upgrade?
Upgrading to a Moderately Complex Testing Lab: The Process
The process required in order to upgrade from a waived to a Moderately Complex testing lab takes time and effort, and may incur cost. Here’s a broad outline of the steps involved in upgrading to a moderately complex testing regimen:
- Upgrade your certificate to a Certificate of Compliance
File a change in certificate type and pay certification fees, as needed.
- Meet personnel standards for moderately complex facilities
These standards include laboratory training, previous experience, or CMEs covering laboratory topics. One option – which has proven popular among Sekisui’s FastPack IP users – is to utilize the University of Iowa’s CLIA Online Certification Course.
- Participate in an approved Proficiency Testing (PT) Program
A Centers for Medicare and Medicaid Services (CMS) approved PT program will evaluate your lab’s accuracy with interpretation and judgment. A list of PT providers can be found at: cms.gov.
- Apply appropriate QA and QC standards
Your lab will need to establish and follow a quality control program, perform Method Verification at installation, and adhere to instrument maintenance schedules as required by the manufacturer.
While requirements must be met and may seem like a significant burden, it can – in many cases – be well worth the investment of time and effort.
There’s Help Available to Evaluate Upgrading Your POL
It is important to ensure your laboratory testing supplier can meet all of your volume and test type needs, has the equipment you need and provides a high level of subject matter expertise to support your POL operations.
In fact, providers such as Sekisui Diagnostics can help. Sekisui has assisted numerous labs in making the transition from a CLIA-waived lab to a Moderately Complex lab using the ready-to-go FastPackTM system. Our subject matter experts can help guide you on decision analysis, approval process and instrumentation.
Want to learn more about upgrading your POL to Moderate Complexity testing? The CMS.gov website is an excellent resource for answering questions on the process.
February is National Heart Month!
Heart disease – often referred to as cardiovascular disease – includes a number of conditions that affect your heart. One of the most common conditions is coronary artery disease (CAD). Others include heart or heart valve defects, narrowed or blocked blood vessels, and problems with heart rhythm.
Know Your Risks, Know Your Numbers…and Talk to Your Doctor
It is easier to treat heart disease when detected early, so discuss any concerns you may have about your heart health with your physician. There are also a number of actions you can take to reduce your risk of cardiovascular disease (see Lowering Your Risk of Heart Disease, below).
Heart Disease At-A-Glance
(includes Coronary Heart Disease, Hypertension, and Stroke)
- Heart Disease is the number one cause of death in the U.S. – and
- Cardiovascular disease accounts for about 1 of every 3 deaths in the U.S. – an average of 1 death every 40 seconds.
- Stroke accounts for 1 of every 20 deaths in the U.S. This means someone has a stroke about once every 40 seconds and someone dies from a stroke about every 4 minutes.
- Heart disease costs the United States about $200 billion each year. The total includes the cost of health care services, medications, and lost productivity.
Heart Disease, Stroke and Cardiovascular Disease Risk Factors
The American Heart Association (AHA) gauges the cardiovascular health of our nation by tracking seven key health factors and behaviors that increase risks for heart disease and stroke. They include:
- physical activity
- body weight
- blood pressure
- blood sugar
The AHA measures these seven factors to track progress toward the 2020 Impact Goal of improving the cardiovascular health of all Americans and reducing deaths from cardiovascular diseases and stroke by the year 2020.
Lower Your Risk of Heart Disease
An important aspect of lowering the risk of cardiovascular disease is managing health behaviors and risk factors, including diet quality, physical activity, smoking, body mass index (BMI), blood pressure, total cholesterol or blood glucose.
How to Prevent Heart Disease
Here are some things you can do to reduce your chances of heart disease.
- Know your blood pressure and keep it under control.
- Exercise regularly.
- Don’t smoke.
- Get tested for diabetes – and if you have it keep it under control.
- Know your cholesterol and triglyceride levels – and keep them within healthy ranges.
- Eat plenty of fruits and vegetables.
- Maintain a healthy weight.
You should also consider regular screenings to monitor your health. Check out the list of recommended screenings and the topics you should talk with your healthcare provider about during your yearly visit.
Know Your Risks, Know Your Numbers
Understanding your risks and knowing your critical health numbers can help you begin to change your health in a positive way – and lower your risk of heart disease.
NOTE: As of June 2017, The American Diabetes Association recommends testing for prediabetes and risk for future diabetes for all people beginning at age 45 years. If tests are normal, it is reasonable to repeat testing at a minimum of 3-year intervals.
Want to learn more about Sekisui Diagnostics’ cardiovascular diagnostic tests? Click here.
Diagnostic Testing at the Point-of-Care: Improving Patient Outcomes While Reducing Practice Costs
Whether it’s diagnosing vitamin D deficiencies, managing thyroid disorders or monitoring prostate cancer, one clear motivation for performing diagnostic testing in-house is the ability to minimize return patient visits for medical decision-making, thereby enhancing patient care.
The average physician’s office sends out a range of samples for testing by hospital, central or reference labs. However, the expanding presence of on-site POLs [ demonstrates that diagnostic testing at the point-of-care (POC) can improve patient outcomes while reducing practice costs and creating additional revenue opportunities. These are several key reasons for starting up a POL. Some other reasons include:
- Healthcare reform and patient-centered care
- Technological advancements (faster, easier-to-use devices)
- Laboratory staff shortages
- Increasing older population and more chronic disease
- Rising incidence of lifestyle diseases (e.g., cardiac, diabetes)
- Increasing trend toward healthcare decentralization
- Long-term savings
- Rural locations with limited lab services
In many cases, bringing some of these outsourced tests in-house can offer other benefits to doctor’s offices, including:
- Increased Efficiencies: allows the practice to function more efficiently, with improved staff efficiency & lower labor costs
- Convenience: allows the physician to deliver results in person, face-to-face, which can foster better patient understanding, retention, and compliance
- Marketplace Differentiation: can provide a competitive advantage for the practice to differentiate it from other practices
- Improved Quality of Care: eliminates the risk that the patient does not return in a timely fashion
- Improved Practice Sustainability: requires less patient record review from previous visits.
MACRA: What this means to the POL
The Medicare Access and CHIP Reauthorization Act (MACRA) will change how Medicare pays for physician services. Most physicians will be paid under the default track of the new program known as the Merit-based Incentive Payment System (MIPS). MIPS Provides incentives and penalties of Medicare professional service payments based on quality and cost performance vs. volume of procedures/tests performed.
Because MACRA rewards clinicians for value over volume same day point-of-care testing can improve two key MACRA objectives: outcomes and quality of care. Diagnostic tests such as Flu, Strep, PSA, Fecal Occult Blood (for colorectal cancer screening) and others are all tests which address MACRA quality measures and move patients along the road to recovery faster while reducing health risks. (SOURCE: https://qpp.cms.gov/mips/quality-measures) Learn more about the full Quality Payment Program.
Physicians’ Office Point-of-Care Testing: Getting Started
When considering what tests to bring in-house, you’ll need to have a thorough understanding of what would be required – from upfront costs, space & staffing, to time or training if upgrading to moderately complex testing.
Once a comparative value of advantages and disadvantages has been explored, your office can make a determination of which tests would be good candidates for your in-house Physician Office Lab.
How a Point-of-Care POL Works
While there are key differences in each medical practice, there are some commonalities among the requirements for a POL: startup funds, appropriate space, staff to train and allocate to testing, and a sufficient testing load to make it feasible and profitable.
Among these requirements the top three considerations are:
Whether your practice is looking to perform CLIA-waived assays or moderately complex assays, it’s important to find a diagnostic test supplier that can address a broad assortment of testing solutions, including instrumentation, assays & supplies.
A Review From a Healthcare Provider
Miramont Family Medicine is a mid-size physician’s office in Colorado that was seeking a way to provide the highest-quality care while maintaining the lowest-cost services to their patients. When Miramont Family Medicine adopted their Patient-Centered Medical Home (PCMH) model – implementing a Physician Office Laboratory (POL) was key part of the model. Their goals were to:
- Improve patient outcomes
- Improve their patients experience, by ensuring patients receive the necessary care when and where they need it
- Provide greater patient convenience,
- Improve practice efficiency and productivity
Miramont found that using their POL resulted in patients receiving their test results during their office visit, which ensured they immediately received their diagnosis and care regimen. Also, Miramont found that utilizing their on-site POL significantly reduced staff labor costs from the 20 minutes it used to take to prepare and send out tests to only 10 minutes per test.
Want to Learn More About Physician Office Labs?
The Sekisui Diagnostics team understands what medical practices need to effectively create and run a POL and can provide them with a comprehensive product line for point-of-care testing.
Contact us today to learn more.
Rapid Diagnostic Tests (RDTs) offer an important range of benefits – for patients, caregivers, healthcare systems as well as overall global health. These include:
- Reducing time to diagnosis
- Fewer patient visits
- More accurate prescribing of medications
- Potential for improved medical outcomes
- Helping detect and control the spread of disease
Preventing Antimicrobial Resistance
A globally significant benefit of increased RDT use is the potential reduction of antimicrobial resistance (AMR, check here for more info). AMR is a critical global health issue, and by helping reduce the overuse of antibiotics the global health community can delay the onset of antimicrobial resistance.
“[Diagnostics] are seen as critical to the battle against antimicrobial resistance, the global significance of which was illustrated by its discussion at the United Nations (UN) General Assembly in September 2016. Diagnostics are also a core component of the World Health Organization’s (WHO) Global Action Plan on Antimicrobial Resistance.”
These benefits have led to increasing development and growing adoption of diagnostics in developed nations, but low- and mid-income nations still lag behind.
Increasing Global Adoption of RDTs
Earlier this year, the AACC published an article on Improving the Global Profile of Rapid Diagnostic Tests. In it, they highlighted discussions during a one-day workshop held by key stakeholders from the U.K.-based Academy of Medical Sciences (AMS) and the InterAcademy Partnership for Health in South Africa.
The panel, comprised of policymakers from these two health policy groups, issued a report calling for increased adoption of rapid diagnostic tests around the world.
The focus of the workshop was on barriers to the widespread adoption of diagnostics – with an emphasis on Low- and Mid-Income Countries (LMICs), as well as developing a series of possible solutions.
The AACC’s article states: “Rapid diagnostic tests (RDTs) are crucial to saving lives in underserved nations, yet they rank low as a global priority, and a number of financial, regulatory, and clinical barriers are hampering their development.”
Potential Solutions for Improving the Use of RDTs in LMICs
Low- and middle-income countries (LMICs) – which feature remote populations and potentially difficult environmental conditions – can be perceived as unattractive market opportunities for manufacturers of diagnostic tests. However the importance of RDTs in global health is well-known. From fighting the abovementioned AMR to stopping the spread of infectious disease, they offer a number of significant benefits to both patients and healthcare providers.
AACC summed up some of the potentially valuable steps the report drafters recommend to improve the use of diagnostics globally:
“To help raise the profile of RDTs, the report’s authors called for the creation of an “essential diagnostics list” for transmissible infections such as Ebola virus or SARS-CoV, and an international organization to coordinate activities surrounding advocacy, resources, and expertise.
In other recommendations…LMICs need more flexible, upgradable tools that support disease surveillance and simple and inexpensive diagnostics to identify non-communicable diseases. Another application in LMICs that deserves attention, particularly in the area of surveillance, is next-generation sequencing and disruptive technology.” [read more]
Three of the solutions discussed in a separate 2016 report by the Academy of Medical Sciences, “Improving the development and deployment of rapid diagnostics tests in LMICs”, are particularly relevant to the global diagnostics industry:
- Locally-Driven Patient-Focused Development
As pointed out, there are two distinct aspects to diagnostics development that come into play: practical issues and ‘human factors.’
On the practical side, developers must take into account:
- reliability in the face of environmental challenges
- the likelihood of an intermittent electricity supply and lack of refrigeration facilities.
The human factors cited include:
- attitudes towards testing
- clinical training and practices
- the often-limited availability of necessary accessories
Consideration of – and emphasis on – these two characteristics “will ensure that diagnostics development is more needs-driven than technology-driven.”
- Enhanced Regulatory Environment
The global regulatory infrastructure tends to be fractured and complicated, creating a need for an outcomes-focused, “coherent, internationally integrated regulatory framework for diagnostics” in which “stringent regulatory regimes should not present unnecessary obstacles to diagnostics developers.” It is recommended that regulators should place a higher priority on patient pathways and outcomes.
- More Flexible Diagnostic Tools
Generally, diagnostics have historically focused on individual conditions or pathogens – but flexible or multifunctional platforms which support differential diagnosis can better address the challenges facing LMICs. The report points out that “these could include multiplex tests that detect multiple pathogens or platforms (such as cartridge-based systems) that support the use of different individual tests. There are also advantages to testing approaches that can be rapidly updated, for example to take account of pathogen evolution and changes in antimicrobial resistance.”
Want to learn more? The AACC article about the panel’s report can be found here – on AACC’s website. You can read the full report that was issued here: Improving the development and deployment of rapid diagnostic tests in LMICs.
The History of Diabetes Testing
Can you imagine diagnosing Diabetes by tasting urine? It’s hard to imagine, especially considering today’s diagnostic tools and techniques.
Early Days: The Urine Taste Test
Diabetes was first identified as early as 1500 BC, and in 600 BC physicians recorded that ants were attracted to sugar in patients’ urine. During the Middle Ages doctors used uroscopy – a practice where they studied urine to diagnose medical conditions. They consulted intricately designed urine flavor charts that described the sight, smell and taste of urine. The one disease that they diagnosed correctly was diabetes because of the sweet taste of a patient’s urine.
In 1674, an English doctor named Thomas Willis described diabetic urine as “wonderfully sweet as if it were imbued with honey or sugar.”
The first clinical test for sugar in urine was developed in 1841 by Karl Trommer, which involved subjecting a urine sample to acid hydrolysis.
A Shift Towards Detection & Treatment of Diabetes
It was the 20th century, however, that truly marked the transition from recognition of diabetes as a condition to detection & treatment regimens. The first use of insulin was in the early 1920s. In 1922, the Oral Glucose Tolerance Test (OGTT) was first introduced.
The 1950’s saw the introduction of urine test strips, refined in 1964 by The Ames Company (a division of Miles Laboratory – eventually acquired by Bayer). Ames followed up in 1970 with the first glucose monitor, but another decade would pass before easy-to-use-at-home glucose monitors emerged. Glucose monitors and test strips –though widely used in the daily management of diabetes – suffer from the drawback of providing only a single data point, and do not take into account how blood sugar levels change, or over time.
Today’s Hemoglobin Analysis
The limited data points of glucose monitors and test strips paved the way in the 1970’s for the development of the A1c test. First proposed as a measure of blood glucose control, it is widely used today in both clinical and research applications. The HbA1c measurement reflects blood sugar over a period of months rather than a single point in time. While blood tests can show if you have diabetes, the A1c test is also useful for indicating how diabetes is being managed.
Modern diabetes diagnostic tools are a far cry from the urine taste testers of the past! Here are some of the up- and downsides of the various testing methods in use today.
Understanding HbA1c Measurements
As with the glucose-based tests, there is no finite threshold of A1C at which normality ends and diabetes begins. The International Expert Committee has elected to recommend a cut point for diabetes diagnosis that emphasizes specificity. Capillary blood A1C measurement – also referred to as point-of-care (POC) A1C testing – is becoming a popular method for office-based monitoring of glucose control.
Newer POC instruments are now available, and although more studies are needed to confirm reliability with standardized assays, the POC method seems promising for convenient monitoring of glucose control.
The tools to diagnose and manage diabetes continue to improve, and better diagnostic tools will remain a focus for Sekisui Diagnostics. Learn more about our HbA1c assays
Discontinuation of Abbott’s MTX Assay Creates Urgent Need in Labs
Due to the importance of measuring Methotrexate (MTX) in patient healthcare, Abbott’s recent discontinuation of the TDx and TDxFLx FPIA Methotrexate assay has left many laboratories actively – and urgently – seeking an alternate testing option.
Why Run Methotrexate Tests in Your Laboratory?
While MTX is used to treat a wide range of conditions – from psoriasis to rheumatoid arthritis to a number of different forms of leukemia and cancer – it also possesses high toxicity. Because of this, patients undergoing MTX therapy for cancer must be closely monitored for early detection of any toxic effects.
MTX measurements are used to monitor levels of Methotrexate in patients to help ensure they receive the appropriate treatment.
Due to the nature of the conditions MTX is used to treat, combined with the need to minimize side effects, time-to-result is critical. If your laboratory must send the test out, vital results can be delayed – potentially affecting patient treatment by the physician.
A MTX Diagnostic Test Option for Your Lab
Among the available MTX testing options is the ARK™ Methotrexate Assay. This is a homogenous enzyme immunoassay intended for the quantitative determination of MTX in human serum or plasma on automated Clinical Chemistry analyzers.
Comparing the ARK™ MTX Assay & the Discontinued FPIA TDx Method
The ARKTM Methotrexate assay possesses excellent correlation to the FPIA TDx method. It can also help streamline lab workflows, decrease turnaround times and increase patient care opportunities. The ARKTM Methotrexate Assay has been the choice of many hospitals across the U.S. to replace the discontinued TDx.
The chart below exhibits the favorable data comparison for the ARK™ Methotrexate Assay versus the discontinued FPIA TDx Method.
Sources: www.ilexmedical.com/files/PDF/TDX_Methotrexate.pdf, http://www.ark-tdm.com/pdfs/2017/Methotrexate/MethotrexateDataRev5May2017.pdf
ARK™ MTX Assay Now Available Thru Sekisui Diagnostics
Sekisui Diagnostics has partnered with ARKTM Diagnostics in offering Methotrexate for the Ortho Vitros and Abbott Architect platforms.
Adding the MTX assay to your existing chemistry platform will help you streamline your workflow while also decreasing turnaround times and increasing patient care opportunities.
Want to learn more about how the ARK™ Methotrexate assay can help ensure patients are getting the appropriate MTX treatment they need? Visit: http://www.ark-tdm.com/DB_methotrexate.html
What’s happening in Australia could spell bad news for Europe and the United States (U.S). This year’s winter in Australia and New Zealand found hospitals struggling with demand in the face of a heavy flu season. Australia saw nearly 2½ times more infections than in the same period last year. As of September 2017, there are a reported 121 deaths in Australia. The dominant circulating strain is influenza A, H3N2 (H3). H3N2 is more resistant to flu vaccinations than most, and often affects children and the elderly.
So what does this mean for Europe and the United States? Public health experts have expressed concerns about the upcoming flu season in Europe and the United States. According to Dr. Anthony Fauci, Director of the United States, National Institute of Allergy and Infectious Diseases: “In general, we get in our season what the Southern Hemisphere got in the season immediately preceding us,” Which means the Northern Hemisphere will probably have a bad flu season.
In the U.S we have been hearing about confirmed cases of influenza sporadically across the nation. In fact, at the University of Arizona nearly 100 “flu-like and confirmed influenza cases” have already appeared, leading county health officials to label it an early start to flu season.
In the UK, the NHS is preparing for the “worst flu season in its history” as the head of the health service has warned that “influenza levels are expected to be high.”
How Many People Does the Flu Impact?
From an infographic by the Center for Disease Control (CDC) Foundation (here), there are approximately 31.4 million outpatient visits and 200,000 hospitalizations each year related to influenza in the U.S.
Its impact isn’t just felt by those who’ve contracted the flu. Each year, the U.S. spends about $10.4 billion in direct costs for flu-related hospital and doctor visits. One CDC study that evaluated the cost of flu outbreaks projected that in the event of a flu pandemic, “the estimated economic impact would be $71.3 to $166.5 billion, excluding disruptions to commerce and society”…in the U.S. alone.
Flu diagnosis has become big business, and the faster doctors receive the results, the better. With strong growth projected into the future, Point-of-Care Testing (POCT) is the fastest growing segment of the diagnostics market, due largely to its promotion of rapid answers and the ability to provide faster clinical treatment. Rapid influenza testing enables the early recognition of patients with influenza and has many potential advantages, including the prevention of unnecessary antibiotic prescriptions, hospitalizations, and influenza transmission.
This year in the U.S. the FDA reclassified antigen-based RIDTs as Class II devices in order to improve the overall quality of testing for influenza. The FDA has provided certain performance criteria that manufacturers will have to meet in order to market their influenza assays. This provides laboratories and physicians peace of mind that their method of POC testing meets their needs.
Sekisui Diagnostics’ OSOM® Ultra Flu A&B (Catalog #1006, view package insert) meets the FDA’s new performance criteria defined in the final rule (21 CFR 866.3328).
Learn more about Sekisui Diagnostics’ CLIA-waived OSOM® Ultra Flu A&B Test here.