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Flu Season Outlook- Severity, Cost and Point-of-Care Testing

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
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.

Trichomonas Rapid Point-of-Care Testing: Uncovering Diagnostic Options

What is Trichomonas?

Trichomoniasis is a common, curable, non-viral sexually transmitted infection (STI) caused by a motile protozoan parasite called Trichomonas vaginalis. Trichomonas (sometimes referred to as “Trich”) infects the vagina and sometimes urethra and is transmitted during unprotected sex. It is roughly as big as a white blood cell, and  thought to be responsible for approximately 15-20% of symptomatic vaginitis infections.

Watch the Health Briefs segment featuring Dr. Charlotte Gaydos, Johns Hopkins School of Medicine

Watch the Health Briefs segment featuring Dr. Charlotte Gaydos, Johns Hopkins School of Medicine

Formerly considered merely a nuisance infection, it is now recognized as a cause of serious health problems – but it continues to be highly underdiagnosed and under-treated.

Trichomonas infection complications can include

  • preterm labor and birth
  • infertility
  • increased risk of HIV/HSV
  • cervical cancer
  • prostate cancer in men
  • pelvic inflammatory disease

The World Health Organization (WHO) estimates an incidence of 276 million new cases of Trichomonas vaginalis each year and a prevalence of 187 million of infected individuals between the age of 15 and 49 years old. However, as the infection is not reportable in U.S. public health programs, the true prevalence data is likely underestimated. Trichomoniasis occurs at higher rates than other curable STIs such as Gonorrhea, Syphilis, and Chlamydia combined.

Testing and Diagnostics Options for Trichomonas
Part of the difficulty in diagnosis of trichomonas is that the majority of people affected do not have any symptoms. It is estimated that around 80% of women and men with trich infections are asymptomatic. Therefore the diagnosis of trichomonas must be laboratory based. When testing for trichomonas, the various diagnostic choices are often limited by either accuracy, timeliness, intended use, or cost.

Improving Patient Care with Immediate Treatment with Point of Care Testing
Treating at the point of care saves time for patients in general, and is especially critical in settings where follow-up can be difficult. And for the physician, the time saved on testing can be used to carry out other important tasks, including educating the patient during the visit.

From a medical standpoint, point of care testing keeps patients from being treated with unnecessary antibiotics. And while the short-term benefit is a cured patient, the longer term benefit is that they can no longer spread trichomoniasis to others.

Open Channel Clinical Chemistry Analyzers- Unleashing the Potential

clinical chemistry open analyzer reagent optionsDid you know you have the ability to unlock your instruments potential and add assays that are not offered by your instrument manufacturer? This open channel capability allows you to expand your test menu beyond your instrument manufacturers menu. This added benefit allows laboratories to enhance their test menu offerings by bringing in higher volume send out and niche testing.

Advantages to using 3rd party reagents:

  • Increase test menu
  • Decrease turnaround times
  • Increased patient care
  • Increase revenue opportunities

Third Party Test Menu Expansion
Although most instrument manufacturers offer extensive test menus covering many disease states, Sekisui Diagnostics can help fill in any gaps that may exist.  We have an extensive range of assays that could supplement your current reagent menu, including some assays not available elsewhere

Reagent Quality
Our FDA cleared assays are easily adaptable to many different instrument platforms and are currently being run in laboratories across the country.

A Backup Vendor: You’re Always Covered
Have you ever experienced a reagent recall or backorder situation and did not know that you have options other than sending the test out? Having more than one chemistry vendor allows you to have a backup supplier in the event of recalls and backorder situations that cannot be controlled by your current manufacturer.

Support Still One Phone Call Away
Many manufacturers understand the need to expand your test menu and will support the use of a 3rd party vendor. Often times, the instrument manufacturer application specialists will assist with the validation of assays they are unable to provide for their customers. 3rd party reagents are also fully supported by their own technical teams so there are plenty of resources available when applying novel assays to your analyzer.

How Do I Get Started
Contact your ChemistryCare representative to discuss your options and learn how we can help. You can also find more information by visiting our website.

Quantifying the Value of Diagnostics: An AdvaMedDx Overview

Diagnostics: The Value of Accurate, Timely Medical Care
While the cost-driven healthcare industry tends to undervalue diagnostics, the role it plays in today’s healthcare environment is enormous – and it only continues to grow.

Without lab results, healthcare practitioners would simply be using guesswork. Bottom line: results matter – and lab tests have an out-sized influence on medical decisions compared to their share of healthcare spending.

A peer-reviewed paper (The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report) which analyzed doctor perceptions on the cost of IVDs, succinctly captured the importance of diagnostics: “Appropriate testing allows early-stage interventions, reducing late-stage healthcare expenditure (HCE).”

Patient-facing clinicians have long known this, and value the ease of use, patient-friendly and time-saving nature of diagnostics in making their practices more efficient and responsive to the patient’s care.

Earlier this year, AdvaMedDx published a thought-provoking report – A Framework for Comprehensive Assessment of the Value of Diagnostic Tests – which aimed to quantify the value of diagnostic testing in our new value-driven model of healthcare.

“AdvaMedDx launched a Strategic Value Initiative, in collaboration with Deloitte Consulting LLP, to develop principles and an approach for assessing the value of diagnostics that can be adopted by diagnostic manufacturers, health systems, payers, and other stakeholders.”

The report details how establishing a value for a diagnostic product means not only understanding the underlying value proposition of the product itself, but also the ability to clearly demonstrate and articulate how that value both translates to patient outcomes and creates stakeholder value.

Value Drivers: Measuring the Value
The report defines a set of four value drivers. These are the four broad ways in which a diagnostic might impact the patient care process.

  1. Clinical impact
    The extent of clinical utility and the health outcomes associated with the diagnostic/imaging technology. (e.g., does it improve the patient’s health or speed up the treatment time?)
  2. Non-clinical patient impact
    The impact of non-clinical benefits for the patient. These would include the patient experience (e.g., is the diagnostic invasive? Is it painful or time-consuming?), and patient economics (what is the out-of-pocket cost?)
  3. Care delivery revenue and cost impact
    The impact on revenue and operating costs relative to the benefits. (e.g., how much does it cost, versus how much does it speed time to diagnosis and accordingly free up a hospital bed?)
  4. Public/population impact
    The broader impact an diagnostic may have on the wider healthcare system, employers or society (e.g., does it have a positive impact on public health?)

The Complexity of Stakeholder Value
The ways in which a diagnostic can affect and influence these value drivers differs according to the stakeholder. According to the report, there are numerous stakeholders in the healthcare continuum: patients, providers, clinical laboratories, employers, patient advocacy organizations, quality organizations, professional medical associations, payers and the government.

While – for all intents & purposes – all of these stakeholders have an interest in promoting positive clinical impacts, they each tend to prioritize their objectives (and the value drivers listed above) differently. As mentioned earlier, diagnostics offer tremendous advantages on the patient-facing side – benefitting both clinicians and the patient – and ultimately the payers.

The value of a manufacturers’ diagnostic product is directly related to their ability to effectively address each stakeholder’s unique set of value drivers.

In some cases, the focus will be on the economies of testing, whereas in other cases the emphasis will be on how the test can improve care delivery – whether for the patient, the provider, or another stakeholder. A different stakeholder – governments come to mind – will de-emphasize individual patient outcomes in favor of the broader public benefits, or the cost.

AdvaMed’s report does a good job highlighting the complexity & dynamism of determining a diagnostic product’s value. They provide a clear demonstration that the value – while clinically critical – can shift according to how all of the various parties measure success against their particular objectives. And with 70% of medical decision-making based on test results, properly valuing diagnostics will continue to be vitally important.

To learn more about AdvaMed’s analysis, you can read the full report here (available as a pdf): A Framework for Comprehensive Assessment of the Value of Diagnostic Tests.

European Commission Launches New Plan to Address Antimicrobial Resistance

The British In Vitro Diagnostics Association (BIVDA) recently highlighted attention in Europe on the subject of antimicrobial resistance (AMR). [NOTE: the BIVDA Weekly Update is behind a members-only firewall.]

In their newsletter, BIVDA shared a link to an article from the Financial Times [also behind a paywall] which coincided with the G20 meeting. The FT article noted that AMR was expected to come up as an issue during discussions on health.

AMR is not a new issue for Sekisui Diagnostics. We’ve discussed AMR and the role Sekisui and its distributors have played in supporting initiatives to reduce antibiotic consumption.

Antimicrobial Resistance: A Global Challenge
The European Commission‘s (E.C.) recent publication – “A European One Health Action Plan Against Antimicrobial Resistance (AMR)” – calls for encouraging the use of “diagnostics in medical and veterinary practice.” Their press release states:

“Today the Commission adopted a new Action Plan to tackle Antimicrobial Resistance (AMR) – a growing threat that is responsible for 25,000 deaths and a loss of €1.5 billion in the EU every year.”

How critical an issue is AMR?
|Worldwide, nearly 700,000 people die annually due to an antibiotic resistant infection. AMR is responsible for an estimated 25,000 deaths in the EU alone. Europe – like many other global regions – is taking it very seriously.

According to Vytenis Andriukaitis, Commissioner for Health and Food Safety, by 2050 AMR could lead cancer as a cause of death if government fails to take action.

The increasing prevalence of AMR can be attributed to a number of factors, from the overuse of antibiotics in livestock to the over prescription and misuse of antibiotics in humans.

From the E.C.’s Q&A: “Lack of awareness also remains a key factor: 57% of Europeans are unaware that antibiotics are ineffective against viruses, 44% are unaware that they’re ineffective against cold and flu.”

The new Action Plan focuses on everyone in the medical or healthcare communities involved in the use of antimicrobials – including nurses & doctors, pharmacies, hospital administration and others. The guidelines are intended to work in conjunction with existing national infection prevention & infection control guidelines in European member countries.

One key aspect of the Action Plan involves surveillance efforts – including use of diagnostics – to improve public health while reducing the misuse of antibiotics. This also includes the research into – and development of – novel diagnostics:

“Novel, rapid and reliable diagnostics are crucial for differentiating between bacterial and viral infections and identifying AMR, so that the most appropriate treatment can be given in a timely manner. By tailoring the treatment to the nature of the infectious pathogen and its resistance pattern, diagnostics help reduce the unnecessary use of antimicrobials in humans and animals. Such novel diagnostics are in the process of entering the market but more tests are needed to guide a more efficient use of existing antimicrobials in the human and animal health sectors. Novel diagnostics will also make it possible to recruit the right patients in clinical trials for new treatments, making the trials more efficient.” [European One Health Action Plan against Antimicrobial Resistance – page 15]

Want to learn more? You can read the EC Action Plan here (pdf file), or learn more about antimicrobial resistance at the European Commission Health and Food Safety website.

Clinical Chemistry: Why Pour Over?

In the field of clinical chemistry, most  manufacture instruments are intended for use with the manufacturer’s specific packaged and barcoded reagents. This is often referred to as a ‘closed’ system.

What some labs are not aware of is that their chemistry analyzer may not be a fully ‘closed’ system.

Why does it matter if your system is closed or open?

If your system is not a closed analyzer, it opens up the option for your lab to use ‘pour over’ reagents. This means you have the option to utilize open channels on the instrument to expand the menu for tests that the manufacturer doesn’t offer.

Pour Over: Commonly Known as Open-Channel,  User-Defined Tests (UDT), or Third-Party,
The process of ‘pouring over’ reagents refers to filling the empty manufacturers’ cartridge (which vary in shape and size, depending on the specific instrument) with a reagent sold in generic packaging.

Advantages of an Open Channel Assay
Although most instrument manufacturers provide extensive test menus for their analyzers, there is an occasional assay that is missing from the test menu. This is where an open-channel assay can help fill in gaps. What may currently be an expensive test for a laboratory to send out to a reference lab, can now be added to the laboratory’s instrumentation bringing in revenue and increasing patient care by decreasing turn-around times.

Another advantage of using an open channel assay is minimizing the amount of waste. Laboratories are able to adapt user-defined assays to fit their testing volume in order to maximize the amount of tests that can be utilized in a reagent kit. Pour over assays give a laboratory the flexibility to place enough reagent on-board the analyzer to last the duration of the reagents on-board stability.

Choosing open channel assays for reagent needs can benefit labs greatly – especially when it comes to convenience. This method gives your lab control over how much reagent is used over a span of time, based on the number of requests for the specific test.

Open Channel Assays Can Increase Productivity & Capabilities
Labs are under pressure to produce more test results with fewer resources, forcing them to identify ways to reduce their total cost of ownership. Operating analyzers that use minimal reagents & consumables can increase the number of tests available in a reagent kit – thus boosting efficiency and saving money.

For many labs, the use of open channel testing is another way to reduce costs – with the added benefit of enabling the lab to perform novel assays – which are often otherwise not available.

If you want to learn more about pour-overs, give us a call at 1-800-999-6578.

What Happened at AACC in San Diego?

This year’s 69th AACC Annual Scientific Meeting & Clinical Lab Expo brought the laboratory medicine industry to San Diego – with a record-breaking 21,300 laboratory scientists and related careers in attendance from July 30 through August 3. Sekisui Diagnostics exhibited at the show, among the more than 2,300 booths.

The range of content covered in the AACC sessions was broad, and some of the topics were relevant to either our clinical lab customers or to Sekisui itself.

One particular topic of interest:

  • One of the plenary sessions – Antibiotic Resistance: A Public Health Crisis – spoke to a globally critical issue we have covered – and will continue to cover here: antimicrobial resistance (AMR). The session noted the evolving diagnostic tools and strategies that can be implemented to help aid in the prevention & control of antimicrobial resistance in medical facilities. AMR has become a serious issue, and is starting to take on the feel of a crisis.Consider:
  • According to the CDC, every year more than 2 million Americans become infected with antibiotic resistant bacteria – resulting in at least 23,000 deaths.
  • Europe isn’t faring any better. the UK government estimates that more than 25,000 deaths occur in the E.U. every year due to drug resistant infections.

As the clinical laboratory industry, we all play a role in helping to solve the problem. Whether it’s the development and deployment of new in vitro diagnostics, or medical practitioners & hospitals implementing better prescribing procedures, governments are starting to pay attention and act. We witnessed this recently with the European Commission’s Health Action Plan Against Antimicrobial Resistance (AMR) report.

Among our extensive diagnostic product lines, the Fastpack® and OSOM® stations were especially busy. There was very strong interest in point-of-care diagnostics this year – a growing trend. We especially noted an uptick in distributors (especially in Asia) wanting to sell Sekisui Diagnostics’ FastPack® IP system. 

On the Whiteboard: How Are You Mastering the Art of Diagnostics?
This year we brought back something we’d done at a previous AACC show but with a new approach which ties into our corporate campaign- an interactive whiteboard where we asked laboratory professionals to share their thoughts on how they are “mastering the art of diagnostics.”

It was a great way to hear from people across the industry. Some writings were filled with best wishes, others with invaluable customer input and feedback. And while some of it may find its way into our promotional programs throughout the year, other whiteboard thoughts will help us understand the needs of our clinical chemistry customers better.

Thanks to everyone who attended this year – and an especially big thanks to the staff (and their weary feet!) managing the Sekisui Diagnostics booth.

We look forward to seeing everyone next year at the 2018 70th AACC Annual Scientific Meeting & Clinical Lab Expo in Chicago – July 29 through August 2, 2018!

Helping Save Patient’s Lives: Diagnosing Sepsis

Sepsis was identified as the most expensive in-patient cost in U.S. hospitals in 2014, costing nearly $24 billion annually. Each year, over 26 million people develop sepsis, and it is responsible for the deaths of more than 5 million children. According to the Sepsis Alliance, severe sepsis takes the lives of 40% of those who contract it.

The Health Impacts of Sepsis
The Sepsis Alliance reports that – of those patients who survive – up to 50% are subsequently faced with post-sepsis syndrome. Sepsis survivors have a shorter life expectancy, can have a lower quality of life, and are 42% more likely to take their own life. Early detection of sepsis is key for ensuring survival and minimizing disability as much as possible.

Caused by any type of infection – from something as simple as a urinary tract infection to the flu or pneumonia – sepsis is fatal for one-third of patients who develop it. Furthermore, sepsis survivors are left irrevocably changed—facing chronic pain and fatigue, post-traumatic stress disorder, organ dysfunction and amputations.

How is Sepsis Detected?
Sepsis diagnosis is made by the patient’s doctor after a thorough review of the patient’s symptoms, history, and other relevant tests. Sepsis can be confirmed via a test that measures the levels of a protein in the blood known as procalcitonin.

PCT Biomarker for Early Diagnosis of Sepsis
A meta-analysis which included 30 studies and 3,244 patients found procalcitonin (PCT) to be a reliable biomarker for early diagnosis of sepsis. PCT values between ≥0.5 and 2.0 ng/mL suggest moderate risk, 2.0–10 ng/mL indicate high risk and values ≥10 ng/mL point to a high probability of developing severe sepsis and septic shock.

According to Diazyme Laboratories’ 510(k) Clearance announcement on April 25,2017:

“Procalcitonin, a propeptide synthesized in the C-cells of the thyroid, has been identified to be more clinically useful and superior than currently used common clinical variables and laboratory tests in the diagnosis of sepsis. PCT is ubiquitously and uniformly expressed in multiple tissues throughout the body. In healthy conditions, PCT levels in circulation are very low. Rising PCT concentrations can be detected within 2 – 6 hours after infectious challenges and peak within 6 – 24 hours. Once an infection is under control, PCT levels decrease. This rapid response is highly specific to bacterial infections and has made PCT one of the most pertinent biomarker’s used in detecting bacterial infection or sepsis.”

The frequency of in-patient cases of sepsis, its high mortality rate and its potentially lasting effects demonstrate the need for better diagnostic tools in order for intervention and treatment to begin as early as possible. An easy-to-administer lab analyzer-compatible assay that can deliver results into the hands of clinicians quickly could have a significant positive clinical impact on halting the progression of sepsis in patients. This PCT assay may be the answer for your lab with a quick turn-around time, low sample volume and wide range of instrument parameters available.

What is the PCT?
The PCT is a latex-enhanced immunoturbidimetric assay. It was designed to be used on a wide variety of lab analyzers capable of reading absorbance at 600 nm. With this method, the PCT in the patient sample binds to specific anti-PCT antibodies on latex particles, causing them to agglutinate.

The relative turbidity created by the agglutination is then optically measured at 600 nm, and is proportional to the PCT concentration in the test sample. To calculate the PCT value, the optical signal is interpolated against a 6-point calibration curve. A suitable sample size is 20 µL, with initial test results available in just 10 minutes.

Is the PCT Assay Effective?
An analysis – Analytical evaluation of the procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Beckman Coulter AU5800 – involved assessing limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, carryover, and method comparison between Diazyme PCT and BRAHMS Kryptor PCT using 129 serum inpatient samples.

Linearity was very good in the range and highly significant agreement was seen between this PCT assay and BRAHMS in a range of concentrations.

As the first homogenous PCT assay meant to be used on clinical chemistry analyzers, it saves both time and money, and can help you save lives.

Want to learn more? We’d be happy to help! Feel free to contact us here.





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