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FDA Reclassifies Rapid Antigen Influenza Testing

On February 13, 2017, the FDA’s reclassification of rapid antigen influenza testing became effective. The reclassification impacts manufacturers of certain diagnostic devices used to test for influenza (flu).

Currently, there are a number of diagnostic tests that can help in the diagnosis of flu. They break down into two broad categories: Point-of-Care-based and Laboratory-based.

In the Point-of-Care Testing (POCT) space, two common techniques are:

  • Rapid Immunochromatographic Detection Tests (RIDTs), including both digital reader systems & traditional, manual read assays.
  • Rapid Molecular Tests

In larger laboratories and reference labs, you may find:

  • Immunofluorescence Direct or Indirect Antibody Staining
  • RT-PCR (nucleic acid methods are the new gold standard, replacing the cell culture)
  • Rapid Cell Culture
  • Viral Tissue Cell Culture

RIDT Tests in the Point-of-Care Setting
Rapid Influenza Diagnostic Tests (RIDTs) are immunoassays that can identify the presence of influenza A and B viral nucleoprotein antigens in respiratory specimens, with results displayed qualitatively. There are a number of commercially-available RIDTs in use in the U.S.

RIDT tests are frequently used in point-of-care settings due to their cost-effectiveness, ease-of-use, and rapid results (often available in 15 minutes or less). These tests give doctors the ability to begin antiviral therapy (while reducing antibiotic use) during a single patient visit – ultimately leading to a decrease in hospitalizations and fewer unnecessary tests.

FDA Tightens Standards, Reclassifies RIDTs
However, there have historically been some challenges with RIDTs and their variability in performance. While they tend to show good specificity, they can deliver less-than-optimal sensitivity in respiratory specimens compared to RT-PCR or viral culture.

In some cases (for example, the H1N1 flu strain in 2009) RIDTs may be unable to detect the virus at all. For this reason, negative RIDT test results should be interpreted with caution given the potential for false negative results – especially during peak flu season in a community.

Based on these concerns, the FDA began work to reclassify 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.

The new standards went into effect in February 2017. According to the FDA:

“The new minimum performance requirements for these tests detecting influenza virus antigens are expected to lower the number of misdiagnosed influenza infections by increasing the number of devices that can reliably detect the influenza virus.”

What Does the FDA Reclassification Mean for RIDT Manufacturers?

For manufacturers who currently have a marketed device that does not meet the minimum performance criteria, a new 510(k) must be submitted demonstrating compliance with the special controls included in the new clinical performance standards before marketing the device.

There are several key takeaways from the FDA’s move:

  1. Rapid Antigen Influenza tests have been reclassified from Class I to Class II medical devices.
  2. Minimum performance requirements are mandated as compared to viral culture or molecular methods.
VIRUS Sensitivity Specificity Sensitivity Specificity
INFLUENZA A 90% (80% CI*) 95% (90% CI) 80% (70% CI) 95% (90% CI)
INFLUENZA B 80% (70% CI) 95% (90% CI) 80% (70% CI) 95% (90% CI)

*CI-Lower Confidence Interval

  1. Annual and Emergency Analytical special controls testing (test panel) will be undertaken by manufacturers to ensure continued performance monitoring. The FDA will collaborate with the Centers for Disease Control and Prevention (CDC) to ensure that an influenza virus analytical reactivity test panel is available to all test manufacturers.
  2. By January 12, 2018, manufacturers are required to be in compliance with the requirements imposed by the FDA to meet the Class II standards for rapid influenza diagnostic testing.

What Does the FDA Reclass Mean for Physicians and Labs?
Facilities testing for flu can continue to purchase their current product up until January 12, 2018 and utilize them until the kit’s expiration date. This provides facilities enough time to assess the performance data against the FDA criteria and engage clinicians and management on the next course of action for flu testing.

OSOM® Ultra Flu A&B Meets New FDA Criteria
We know you’re concerned about diagnosing patients correctly – especially during flu season, when so many symptoms can mimic other diseases.

Sekisui Diagnostics is committed to ensure that our products comply with the requirements imposed by the FDA to meet the Class II standards for rapid influenza diagnostic testing.

The OSOM® Ultra Flu A&B (Catalog #1006, view package insert) meets the performance criteria defined in the final rule (21 CFR 866.3328).

Questions about a Sekisui Diagnostics’ Rapid Influenza Diagnostic Test? Give us a call!

Notes from EuroMedLab Athens 2017

Sekisui Diagnostics recently exhibited at the 22nd IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine – perhaps best (and more easily) known as “EuroMedLab 2017.” It’s a large show – attended by about 5,000 biochemists, biologists, doctors, clinical chemists and pharmacists from all over the world.

Ancient History…and Cutting Edge Clinical Innovation
The congress was held at Athens’ Megaron Convention Centre. Within walking distance of the IFCC EuroMedLab 2017 congress venue were an incredible array of places of interest, all within a relatively small area surrounding the city center (Syntagma Square).

The multi-level exhibition area – which at first seemed confusing – actually led to people exploring the halls and discovering new companies. This resulted in a steady stream of visitors to the booth throughout the show.

What Was Hot at IFCC EuroMedLab?
There was a great deal of interest focused on our SEKURE® TPLA/RPR assays, used as an aid in the diagnosis of syphilis, which has been on the increase again since 2000.

Much of the interest in our TPLA/RPR assays can be attributed to the changing nature of lab & clinical testing in general. TPLA and RPR have begun shifting from the microbiology laboratory to the clinical chemistry laboratory.

Our Hb1Ac assay was also the focus of attendee interest (more on that below).

More generally, show attendees were introduced to the latest innovations from the fields of clinical chemistry, molecular diagnostics, cell counting and immunochemistry.

Innovations in Lab Medicine
The EuroMedLab 2017 scientific program offered a wide range of presentations, symposia, discussions, open sessions and workshops – all geared towards sharing recent state of the art innovations in 21st century Laboratory Medicine.

The Future of Point-of-Care Testing
Among the highlights of the congress, were some engaging sessions on Point of Care Testing (POCT). A number of point-of-care topics – assessing reliability, functionality, connectivity, clinical significance, and early clinical decision-making – were analyzed & discussed.

Other sessions reviewed existing and emerging technologies in the POCT field, and assessed the shifting of laboratory tests from central laboratory facilities to the clinic, family practitioners, and – in some cases – the patient’s home.

EuroMedLab Satellite Meeting: A Focus on Diabetes
We were also a sponsor and exhibitor at a related, two-day satellite meeting held June 15-16, immediately after EuroMedLab.

The meeting – held in Sounio, southeast of Athens – addressed diabetes innovations in both the laboratory and the clinic.

About 120 international delegates and key opinion leaders with a specific interest in diabetes participated in the meeting. Sessions provided a review of the state of the art in glucose monitoring, HbA1c, and future developments in diabetes and test methods.

The meeting presented an excellent opportunity to not only meet experts in the field of diabetes and HbA1c, but also to keep updated with the latest clinical & scientific thinking, and gain insight about other current market developments.

Sekisui participated in the HbA1c component of the meeting, which complemented the imminent launch in Europe of Sekisui Diagnostics’ new SEKURE® HbA1c enzymatic clinical chemistry assay. We were able to discuss this new assay with delegates at our table-top display.

There has been much deliberation on the topic of HbA1c. The session on the subject at the satellite meeting proved no exception: lively debate and discussion occurred with a number of topics, including:

  • HbA1c’s role in diagnosis.
  • controversies in interpretation.
  • HbA1c in the POCT setting.

Vitamin D Point-of-Care Testing: Faster, Simpler & More Cost-Effective

Vitamin D Point-of-Care Testing: Faster, Simpler & More Cost-EffectiveWhile Vitamin D is typically recognized for boosting tooth and bone health and warding off osteoporosis, studies are now finding that it can also protect us from malignancy, cardiovascular disease, diabetes, and bone disorders. Genome-wide analysis has also shown that Vitamin D plays a role in the expression of more than 200 human genes.

Uncovering Vitamin D Deficiency
Vitamin D deficiency has been found to be more widespread than previously thought. This deficiency has sparked creation of new guidelines for defining Vitamin D insufficiency and deficiency, along with recommended daily intake.

While this awareness has made testing more prevalent, its standardization is the result of advances in technology, immunoassay methods and automation. Today’s rapid, quantitative analytical techniques are faster, more cost-effective and more adaptable to a Point-of-Care setting—a win for both physicians and patients.

Recent studies have shown that a substantial percentage of the U.S. population has blood levels of 25-OH Vitamin D that approach the cut-off for Vitamin D insufficiency. This risk is multiplied when you use certain therapeutic drugs, including long-term steroids, antiepileptic drugs, L-thyroxine, gonadotropin-releasing hormone agonists, chronic lithium therapy, thiazolidinediones for diabetes, as well as antifungals, AIDS medications, and antacids.

Recommended Vitamin D Intake and Blood Levels
Daily Vitamin D3 intake recommended by the Institute of Medicine of the National Academies:

  • 600 IU/day for everyone up to age 70
  • 800 IU/day for everyone 71 years and older

These amounts correspond to a serum 25-OH Vitamin D level of at least 20 ng/mL.3. In addition, the Endocrine Society Task Force defines sufficient 25-OH Vitamin D as 25-50 ng/mL.

Advantages of Today’s Advances in Testing
In the past, Vitamin D has been quantified through competitive binding, using either high performance liquid chromatography (HPLC) or radioimmunoassay (RIA). For large reference laboratories, LC-MS/MS has become the gold standard. The high cost of the equipment and the staff training required make it unsuitable for point-of-care testing.

Wide availability of HPLC test kits has made HPLC-based Vitamin D analysis much more streamlined and affordable.

Advantages of immunoassay-based testing include:

  • Results which correlate more closely with LC-MS/MS than the results of HPLC-based assays
  • Easy-to-use, cost-effective kits are available that quickly and accurately measure 25-OH Vitamin D in plasma or serum.
  • Reimbursements are available for each test conducted in-house by physician practices in the U.S., providing a faster return on the practice’s investment.
  • Immediate results of monitored 25-OH Vitamin D levels make for better patient care and significantly enhance efficiencies for the physician’s practice

The precision and accuracy of today’s automated immunoassays have been shown to equal that of a centralized lab. Requiring no specialized expertise, they offer rapid results in 15 minutes or less – rather than hours later if the sample was sent out for testing. With the push of a button on the FastPack® IP System, for example, complex immunoassay results can be obtained in 12 minutes.

Thanks to on-demand testing, physicians only need one face-to-face visit to test for deficiency and treat it, or monitor Vitamin D levels and adjust supplementation as needed – saving time for both the patient and the physician. This point-of-care testing allows the patient to receive proper supplementation more promptly, guards against the consequences of deficiency, and leads to greater patient satisfaction.




Sekisui Diagnostics Exhibits at American Urological Association Annual Meeting

The 2017 Annual Meeting of the American Urological Association, held at the Boston Convention and Exhibition Center in May, saw excellent turnout. Some of the educational sessions were highly relevant to Sekisui Diagnostics.

This was the 112th annual meeting of the AUA – a leading industry organization for urologists and global urologic health care professionals and the “largest gathering of urologists in the world.” It is an excellent venue for learning the current developments in research, as well getting a first-hand look at some of the latest technology used in urologic medicine.

This year’s event was truly global in nature, with a large international presence representing (among other places) Liberia, the UK, New Zealand, Uruguay, Egypt, South Africa, Spain and elsewhere. Without fail, Point-of-Care testing was top-of-mind – especially among doctors and medical practitioners.

Hot Topics at AUA
In addition to cost, EMR interfacing was one of the most common questions our team fielded at the show. In fact, we’ve been fielding this question more and more frequently in the past few years as Electronic Medical Records have become standard industry practice. (Sekisui Diagnostics Fastpack IP system has the ability to download test data and interface with practice EMRs through a data port).

Of particular interest to attendees was Sekisui’s PSA test (read our earlier post on the Prostate-Specific Antigen, or PSA, Test). As mentioned above, there were a number of sessions relevant to the topic of prostate cancer.

Among them was Dr. Isaac Yi Kim (Research does not support changes to active surveillance criteria based on race, lecturer says), who referenced the disparities between African American men and Caucasians in the incidence of prostate cancer. At Monday’s Plenary session, Dr. Kim – Acting Chief of the Division of Urology at the Rutgers Robert Wood Johnson Medical School and Chief of the Section of Urologic Oncology at Rutgers Cancer Institute of New Jersey – stated “there are not enough data at this time to support modifying active surveillance criteria based on race.”

In another roundtable session moderated by Dr. Ian Thompson, Jr., experts discussed some of the challenges presented by prostate cancer, including “prostate specific antigen (PSA) recurrence in patients who have undergone radical prostatectomy.”

A number of other sessions – including poster sessions – also focused on the topic of prostate cancer – from screening & detection through to treatment & follow-up.

Other products of interest at the AUA show included our bacterial vaginosis (BV) tests, as well as other rapid tests & diagnostics from our extensive women’s health product line.

All in all, it was wonderful to catch up with our customers. Especially nice: receiving the feedback that some Sekisui Diagnostics products & systems with nearly a decade-and-a-half of hard clinical use are still going strong and delivering value for our customers!

Prostate Cancer Screening: Early Diagnosis Delivers Best Outcomes

Prostate cancer represents about 27% of all cancers in men, and is the second deadliest form of cancer. Last year, an estimated 26,000 men died of prostate cancer.

The American Cancer Society’s estimates for prostate cancer in the United States for 2017 include:

  • about 161,360 new cases of prostate cancer.
  • about 26,730 deaths from prostate cancer.
  • about 1 man in 7 will be diagnosed with prostate cancer during his lifetime.
  • Prostate cancer develops mainly in older men. About 6 cases in 10 are diagnosed in men aged 65 or older, and it is rare before age 40. The average age at the time of diagnosis is 66.

(Read more at the American Cancer Society).

African-Americans at Higher Risk
According to the Prostate Cancer Foundation: “African-American men are the group – out of all men in the world – hardest hit by prostate cancer…[and] are 1.6 times more likely to get prostate cancer, and more than twice as likely to die from it.”

An article at Wiley’s Newsroom pointed out:

“a new study indicating that higher prostate cancer death rates among black men in the U.S. may be due to a higher risk of developing preclinical prostate cancer, and a higher risk of that cancer progressing more quickly to advanced stages. The investigators estimated that 30 percent to 43 percent of black men develop preclinical prostate cancer—prostate cancer that is not symptomatic—by age 85, a risk that is 28 percent to 56 percent higher than that among men of any race.”

This further highlights the need for prostate cancer screening among at-risk populations.

The PSA Test
The Prostate-Specific Antigen (PSA) test measures the level of PSA in a man’s blood. Because the PSA biomarker is only expressed in prostate tissue, it can aid in the early diagnosis of prostate cancer.

PSA Testing: Controversy…or Just Confusion?
The confusion surrounding the use of PSA testing — when to screen and when not to screen — continues because prostate tumors may be very slow-growing (in general, about two-thirds of prostate tumors are categorized as slow-growing), and require only monitoring.

It is important to understand that the controversy around PSA screening is not about the PSA test, but rather about when or whether to treat based on the test result.

Since the FDA approval of the PSA test in 1994, the age-adjusted mortality rates for prostate cancer in the U.S. have declined 50%. (In that time period, mortality due to prostate cancer has declined more than mortality for any other type of cancer.

The value of PSA screening in terms of early detection of prostate cancer and reducing related morbidity, mortality, and cost is well established, when implemented in combination with passive surveillance.

Revised USPSTF Prostate Cancer Screening Standards
In April, the U.S. Preventative Services Task Force (USPSTF) released new draft guidelines for PSA prostate cancer screening – bringing it more in-line with American Urological Association and American Cancer Society recommendations.  (Read more on the draft recommendations at

The 2017 draft recommendations are based on new findings tracking PSA testing in clinical trials. From an April 11, 2017 article (Men Should Ask About Prostate Cancer Test, Panel Advises – 4/11/17) comes this:

“After following patients for a longer period of time, it was shown that for every 1,000 men screened, one to two lives were saved. “We are more confident about the benefits of screening,” said Bibbins-Domingo. “We now think, on balance, there is a small benefit.”

PSA – 15 Minute Results
Testing confusion aside, two of the benefits of the PSA test are the ease of testing and rapidity of results. Patients – tested in a doctor’s office during a visit – can receive the results in 15 minutes.

This can potentially eliminate the need for a follow-up visit to review results – and allow the doctor and patient to develop a follow-on plan of action – if any is needed – during the initial visit.

Sekisui Diagnostics recently sponsored a webcast at Clinical Lab Products on this topic: Critical Thinking for Early Diagnosis of Prostate Cancer. It is available, on-demand free (Duration: 1 hour, 5 minutes). The webcast – moderated by Steve Halasey, chief editor of Clinical Lab Products. – explores:

  • The current controversy surrounding screening and diagnosis of prostate cancer.
  • The importance of digital rectal examination.
  • Optimizing the clinical application of PSA testing.

Point-of-Care Testing & the Fight Against Antibiotic Resistance

A paper published in 2015 – Narrative review of primary care point-of-care testing (POCT) and antibacterial use in respiratory tract infection – discussed the frightening scope of the problem with antibiotics today:

“Antimicrobial resistance is a global problem and is being addressed through national strategies to improve diagnostics, develop new antimicrobials and promote antimicrobial stewardship.”

It’s not a surprise that antimicrobial resistance (AMR) – the ability of a microbe to withstand drugs previously used against them – is an issue fast reaching crisis proportions. Resistant microbes are difficult to treat – especially with few new drugs in the arsenal….or in pharma’s pipeline. In fact, the World Health Organization had pointed out the challenges back in 2014:

“This serious threat is no longer a prediction for the future, it is happening right now in every region of the world and has the potential to affect anyone, of any age, in any country. Antibiotic resistance is now a major threat to public health.”

According to the CDC, every year more than 2 million Americans become infected with antibiotic resistant bacteria – resulting in at least 23,000 deaths. The problem is global: the UK government estimates that more than 25,000 deaths occur in the EU every year due to drug resistant infections.

It’s a crisis being driven by two principal developments (or lack thereof):

  1. Over-prescribing antibiotics
  2. The scarcity of new classes of antibiotic drugs 

Trade Association Engagement
The UK Department of Health’s Five Year Antimicrobial Resistance Strategy calls on industry and trade associations to contribute to the work of tackling AMR. In keeping with this, BIVDA (British In vitro Diagnostics Association) has established an AMR working party which meets quarterly and includes representatives from more than 40 different IVD companies. Sekisui Diagnostics is one of the participating companies.

Pharmacy Strategy
A July 2016 paper in the Journal of Antimicrobial Chemotherapy, “A Feasibility Service Evaluation of Screening and Treatment of Group A Streptococcal Pharyngitis in Community Pharmacies,”concluded:

“it is feasible to deliver a community pharmacy-based screening and treatment service using point-of-care testing, and that this type of service has the potential to support the antimicrobial resistance agenda.”

To drive this idea forward, Sekisui Diagnostics’ distribution partner in the U.K. – Una Health – in collaboration with pharmacy sector consultants Connect-2-Pharma have engaged in a variety of awareness campaigns. These campaigns aim to create awareness among the community pharmacy segment, and drive adoption of Rapid Testing using OSOM rapid tests (principally for Strep-A, and Influenza) within the community pharmacy setting.

The Diagnostic Solution – Promoting “Less is More”
Diagnostics are a critical counterpart to ongoing drug R&D, which alone will not be able to eradicate AMR.

Point-of-care testing is one of the most powerful tools available today in the fight against AMR. Every single use, rapid, disposable test can enable better decision-making at the point-of-prescription, and prevent the unnecessary or erroneous use of an antibiotic.

Sekisui Diagnostics Welcomes You to Dx Dialogue

Welcome to Dx Dialogue, where we’ll be sharing news, product information, as well as Point-of-Care testing, clinical chemistry, coagulation and enzymes product insights and more!

For those of you visiting Sekisui Diagnostics for the first time, we are a diverse company with broad product lines, a global sales and distribution network, extensive product development capabilities, state of the art global manufacturing facilities and deep diagnostics expertise. Our products and global presence are long-standing and significant, with more than 1.7 billion tests performed each year using our clinical chemistry products.

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Finally – since Dx Dialogue is focused on providing you with the information you need – we welcome your topic suggestions and questions.  Reach us by email here.

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