Articles & Experts

Vivalytic’s rapid coronavirus test delivers results for positive samples in less than 30 minutes

Sunday, December 20, 2020

By Randox Laboratories

Cloud-based software update means a faster PCR test for SARS-CoV-2

We are happy to announce that due to improved software for the Vivalytic analysis device, the CE marked Vivalytic SARS-CoV-2 rapid coronavirus test, which uses polymerase chain reactions (PCR), now delivers its results even faster. By applying optimized evaluation strategies, the Vivalytic analysis device can detect a positive SARS-CoV-2 sample through its high viral load in less than 30 minutes, right where the sample is collected.

COVID-19 Testing at the Point of Care

Sunday, April 26, 2020

by Aaron Medaris - Publisher, Physicians Office Resource

COVID-19 needs no introduction. This virus, which is 1/1000th the size of a grain of sand, has singlehandedly bought countries, people and businesses to a complete stop. It fills our news feeds, our thoughts, and dictates our actions. We know that humans are resilient and that we will come out on top, but COVID-19 has brought change and heartbreak along the way. During this time of emergency, we express our sincerest praise to all of you who are constantly putting yourselves in harms way to serve and heal another.

PSA: To Screen or Not to Screen? That is the Question…

Sunday, April 26, 2020

by Sekisui Diagnostics

There are certain milestones in life that no one looks forward to—having your wisdom teeth pulled. That first mammogram! At the top of the list for men is likely that first rectal exam at 40 or 50 as an initial screening for prostate cancer. But, like those pesky wisdom teeth and the oh-so-important mammogram, screening for prostate cancer is important and necessary.

Diabetes Patient Management: The Pros, The Cons, and the Costs of Insulin Pump Therapy

Sunday, April 26, 2020

by David Kliff - The Diabetic Investor

Insulin pump therapy has long been recognized as one of the most effective therapy options for both Type 1 and intensively managed Type 2 patients. There are hundreds if not thousands of studies that have shown how the use of an insulin pump improves patient outcomes. Over the years insulin pumps have made some substantial leaps in terms of usability features and benefits. While more complex than multiple daily injection (MDI) therapy, insulin pump therapy has also become more patients and physician friendly.

Multiplex assay for 10 sexually transmitted infections receives CE marking

Monday, March 09, 2020

by Randox Laboratories Ltd.


Multiplex assay for 10 sexually transmitted infections receives CE marking

CE marking has been granted to one of the most comprehensive cartridge-based STI tests.

The test, developed by the UK’s largest health diagnostics company, Randox Laboratories, tests simultaneously for 10 of the most common sexually transmitted infections, on the firm’s patented Biochip Technology.

Diabetes Patient Management: Time in Range the Newest Metric

Saturday, February 22, 2020

by David Kliff - The Diabetic Investor

Diabetes management has changed dramatically with each new technological innovation. It wasn’t that long ago when knowing a patient’s glucose level was basically guess work. Yes there were tools to measure glucose, however these tools were difficult to use and highly inaccurate. This all changed with the invention of blood glucose monitors which measured glucose using a drop of blood.  Although the process wasn’t perfect; for the first-time patients were able to accurately measure their glucose levels on a regular.

Quality Control at Point of Care Testing

Saturday, February 22, 2020


Introduction to POCT

Point of care testing (POCT) refers to testing that is performed near or at the site of a patient with the result leading to a possible change in the care of the patient. The popularity and demand of POCT has been growing rapidly, however, this should come as no surprise as there are many advantages to POCT, for example, the convenience of being able to obtain a rapid result at the patient’s bedside, thus allowing immediate action, saving time and improving the potential outcome for the patient.

Although there are many benefits of using POCT devices in terms of their convenience, these benefits are only true if the results produced are both accurate and reliable. Ensuring accuracy and reliability is the primary responsibility of Quality Control.

Before You Buy: Which Flu Test is Right for your office?

Saturday, February 22, 2020


By now, physicians may have an idea of what’s to come this flu season, based on how the flu season has already played out in other parts of the world. In previous years, however, despite forewarnings, the United States and European countries are sometimes caught off guard with a “Perfect Storm” of challenges for the influenza season. Physician offices should be stocking up on flu tests and other supplies in preparation for this year’s flu season. What do they need to know before they choose a flu test?

Best in Mobile Health Technologies 2019

Thursday, July 18, 2019


“When will we wise up and stop calling the tiny computers in our pockets ‘phones?’” sighs the distraught geek on the internet, in your office, or on your Facebook timeline. Of course he’s absolutely right about it, even if a little bit prosaic. The “phone” function of our smartphones really only accounts for a small fraction of its total functionality, and NO ONE needs to comment on the ubiquity of these things anymore. Our pocket computers can do most everything our desktop and laptop computers can, and they're uniquely portable and capable of transferring data across (nearly) infinite distances. These little devils also have a steady hand in constantly updating the way that virtually every occupation functions, sometimes just in the nuts and bolts and sometimes drastically.

5 Must-Haves for Great Physician Online Profiles

Thursday, July 18, 2019


Patients have a lot of choices when it comes to physicians.  Making sure your online profile is up to date, complete, and contains these five items will improve the chances that a website visitor will become a patient.

Create a personal connection. Having good rapport with patients is important, and that process starts before patients ever walk in the door.

Value-based Mobile Technology

Thursday, July 18, 2019


The convergence of two powerful forces are changing the practice of laboratory medicine in ways never imagined a generation ago.  These twin forces are the movement to value-based healthcare from the fee-for-service model and the rapid development of mobile technology allowing for continuous healthcare monitoring of patients beyond the clinical setting.

Top 5 Criteria for Choosing a Chemistry Analyzer for a POL

Thursday, June 20, 2019


Q: What would you consider the top 5 criteria for someone choosing a chemistry analyzer for a POL running tests for 5-10 family practice or internal medicine providers? In working on this process I've been comparing the CV's for Proficiency testing for analytes on two systems. One is a system that has hundreds of sites; the other has fewer than 20 in their peer group. Do CV values become more significant with bigger peer groups?

Following Manufacturer’s Instructions Required for Certificate of Waiver

Thursday, June 20, 2019


According to the CLIA regulations, “laboratories eligible for a certificate of waiver must follow manufacturers' instructions for performing the test.”  This is also a requirement for non-waived testing.  Many people think that they are fulfilling this requirement if they follow the step-by-step procedure for the test process included in the instructions.  However, there is much more involved than just following the procedural steps.

Manufacturer’s instructions are found in instrument operator’s manuals and in package inserts; however, this article focuses on the instructions found in package inserts.  In addition to the procedural steps, the package inserts include information and instructions for 

How In-House Testing Steers Income to your Practice

Thursday, June 20, 2019


In a changing medical landscape, physicians willing to invest in their practices are the ones who'll succeed. Though evolving technology and its subsequent improvements in patient care have brought substantial changes to the medical sector, an era of economic uncertainty and fiscal instability may wring just as prescient an effect. According to an article by Ben Brown, MD, reductions in Medicare contract payments (some as much as 21.3%) and physician reimbursements from insurers might result in critical decreases in physician salaries, medical profits and general revenue for a practice. What proves even more concerning for physicians and patients alike, is a present medical landscape of high healthcare costs, an ever-increasing need for healthcare options and diminishing resources. Furthermore, caring physicians want to be effective providers for their patients, but they also want the appreciation and financial compensation for their profession demands.

Have You Intentionally or Unintentionally Become A High Complexity Lab?

Wednesday, May 22, 2019


There may be circumstances when laboratories consider the option to modify an FDA-cleared or approved test system. These may be due to the specific needs of the population served, or based on cost/benefit analyses of instrumentation and reagent use; or based on the logistics of in-house testing capabilities.  CLIA allows clinical laboratories to modify their FDA-approved tests, and even to develop their own tests, known as laboratory-developed tests (LDTs), as long as they follow the requirements to validate the performance characteristics of their modified or in-house developed tests.

The Role of Telemedicine in Monitoring Blood Pressure

Thursday, May 09, 2019


Hypertension, or high blood pressure, is a leading cause of heart disease and stroke that has escalated to alarming rates in recent years, affecting nearly 1 in 3 adults in the U.S. In an attempt to reduce its prevalence, the Eighth Joint National Committee (JNC-8) released a set of hypertension management guidelines. However, various concerns arose regarding the recommendations and as a result, the American College of Cardiology (ACC) and the American Heart Association (AHA), along with nine additional specialty organizations, published an updated hypertension guideline in November 2017.

3 Tips From An Attorney To Avoid A Medical Malpractice Lawsuit

Thursday, May 09, 2019


Twenty years of defending doctors and hospitals in medical malpractice cases has made me into a nervous patient. When you see the worst, you look for it. At least I do. That’s why when I was scheduled for a minor elective procedure, I was nervous. I set aside the day, canceling all of my depositions and planning to spend the day on emails and phone calls. My specialist’s office texted me to confirm the procedure date, which was a week away. Then I received an email from her office with the same date, but a different location. This made my med mal antenna go up, but I told myself to chill.

How Do Fitness Trackers Fit In The Future Of Health Care?

Thursday, May 09, 2019


I view medicine as a team effort. Doctors, nurses, technicians, and patients work together to promote and improve health. Recently some new members have joined the team:  My patients’ Fitbits, phones, and watches.

Mononucleosis: The Forgotten Respiratory Condition

Monday, April 01, 2019


For patients and physicians alike, it may feel like we’re bombarded with flu warnings from all sides, especially after the brutal 2017-2018 flu season. Walk into almost any drug store or grocery store and you’ll see signs advertising that flu shots are available. Clinicians likely have signs in the waiting room reminding you to get your vaccination, and once the season starts, cable news will certainly report on the severity of the virus this year.

Laboratory Test Information for Today’s Patients

Saturday, March 09, 2019


As we enter the third decade of the twenty-first century, the practice of medicine continues to undergo rapid change, led by advances in molecular diagnostics and genetics, enabling the practice of personalized medicine; advances in mobile and point of care testing technology, enabling medical care in remote as well as non-traditional settings; an ever-more intensely information-driven society where ready access to one’s personal medical information  is now expected, enabling and encouraging patient involvement  in their own healthcare; and finally, change is led by the growing realization of financial constraints due to demographic changes leading to the adoption of a value-based approach to healthcare delivery.

The Secret To Making A.I. Work For Physicians

Friday, February 01, 2019


If you are a physician or know a physician or have ever visited one, chances are you have probably heard them complain about technology in health care. More to the point, they are likely to be complaining about the one piece of technology that affects their lives minute-to-minute: the electronic health record (EHR). To get a sense of how central EHRs are to our daily routines, consider that physicians now spend more time in the EHR than they do seeing patients (6 hours of an average 11-hour work day). And while it is easy to write them off as luddites unable to adapt to new technology, an important study by the RAND organization noted that physicians approve of EHRs in principle and see the potential for the technology to improve the delivery of clinical care.

Adapting to Change: How Resilient is your Laboratory?

Wednesday, January 09, 2019


The 21st-century challenge is to redesign healthcare systems to be safe, efficient, effective, timely, equitable and patient-centered. Laboratory medicine is integral to many of these objectives, involving disease prevention, diagnosis, treatment, and management. 

To The Lab: How In-House Testing Steers Income To Your Practice

Tuesday, January 01, 2019


We all laughed at Casey, bright-eyed and eager, when we started our hike. He'd seemingly bought out an entire military surplus store in preparation, while we'd opted (through a heady combination of laziness and daring) to pack as little as possible. Most curiously was Casey's hand-pump micron water filter. Roughly the size of a cinder-block and forged from heavy metal, we snorted incredulously as he clipped the device to his pack, hiked up his shorts and started his journey, clattering like an old Buick.

Medical Buzzwords Can Be Fun, But They Don't Do Much Good

Thursday, November 01, 2018


There’s an increasingly circulated anecdote (usually among graphic designers) about a big-time representative from a big-time tech company meeting before a middle school class. He asks the students, presumably born in the early 2000s, if they know what a floppy disk is. He's met with silence. Then, he produces a floppy disk from his sport coat pocket and shows it to them. “This is a floppy disk,” he says, turning it over in his hands to show them. “Now, have any of you seen one of these before?” After a few more beats of silence, a child raises her hand to say that she recognizes the object as the icon she clicks on to save her progress on Microsoft office. A few seconds later, another child raises his hand because he’s seen it on his Angry Birds game. A wave of recognition floods the classroom as the children place a function and a purpose to a tangible object they’re encountering for the very first time. 

Prostate Cancer Screening: Early Diagnosis Delivers Best Outcome

Thursday, November 01, 2018

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:

Strategies Necessary to Achieve Quality Waived Testing

Tuesday, October 09, 2018


The Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) created the concept of waived tests which are defined as tests that are so simple to perform, and produce accurate results so reliably, as to render the likelihood of erroneous results negligible; and which also pose no reasonable risk of harm to the patient even if the test is performed incorrectly. Thus, these tests are exempt from federal requirements for personnel qualification, training, and competency assessment; quality control (except as specified by the manufacturer), proficiency testing, quality assessment, and the need for routine inspection.

Are You a Tigger or an Eeyore at the Office?

Monday, October 01, 2018


Most everyone is familiar with A. A. Milne’s characters from The House on Pooh Corner. Eeyore is always down and depressed, moves and talks very slowly, thinks everything is bad and getting worse, and drags everyone down with him. Tigger, on the other hand, is always the life of the party, he is constantly smiling, moving and talking rapidly, dancing and jumping and bringing everyone’s attitude up a notch. Tigger is fun, fun, fun, fun, fun. If you asked each of your office staff which one of these two characters best describes you, what would they say? Is that the answer you want to hear?

Molecular Lateral Flow Diagnostics- A New Era for Point-of-Care Testing

Monday, October 01, 2018

If you’re like many physicians and Point of Care (POC) laboratories, you may be dealing with suboptimal performance from some of your current diagnostic methods. For example, conventional Rapid Influenza Diagnostics Tests (RIDTs) vary in terms of sensitivity and specificity when compared with viral culture or reverse transcription-polymerase chain reaction (RT-PCR). Product insert information and research publications indicate that in general, RIDTs sensitivities are approximately 50-70%. 

Evaluating Memory Loss in Primary Care – A New Approach

Saturday, September 01, 2018

How Do You Evaluate Memory Loss?

When an individual begins to show signs of memory loss, a physician’s greatest challenge is often discovering the underlying cause of symptoms. Behavioral evaluations (including self-report questionnaires such as MoCA and MMSE, effort-based computerized testing, and psychological evaluations) and laboratory tests (such as APOE genotyping and biochemical labs such as blood, urine, and CSF analysis) can be useful in developing a diagnosis in cases of advanced symptom presentation1. But how useful are these tools in assessing cases of early memory loss? Are they capable of detecting dementia early, before disease advancement, so that the physician has the opportunity to implement a successful treatment intervention?

Laser Lipolysis, an FDA Approved Inch Loss Technology

Wednesday, August 01, 2018

Painless and rather instant Results

Laser Lipo, Ltd with headquarters in England has developed an advanced body contouring device which directly targets the adipocyte cells leaving the other cells unaffected. Laser diodes using a wavelength of 660 nm creates a photo-chemical reaction in the cell membrane stimulating the cells to temporarily open a pore, and very naturally to release water, glycerol, and free fatty acids. The fat cells then shrink in size. The excess fat is then removed safely through the lymphatic system and the body’s natural metabolic process, thus creating a similar reaction as if the person was exercising. This device allows practitioners to target the areas where patients want the fat gone without any discomfort or downtime. 

Group A Streptococcal Pharyngitis Testing Guidelines & Procedural Limitations

Wednesday, August 01, 2018


Strep tests are used to determine if a person with a sore throat (pharyngitis) has strep throat, an infection of the throat and tonsils caused by the bacteria Streptococcus pyogenes, also called Group A Streptococcus (GAS), or if the sore throat is caused by a virus.  The majority of sore throats (70%-85%)1 are actually viral in nature, and will resolve without treatment within a few days.  

Point of Care Testing (POCT): What’s New?

Monday, July 09, 2018


It has been one of the primary goals in the reformation of our healthcare system to have patients more involved in managing their own health. The Affordable Care Act (ACA) promotes the shift from curative to preventive medicine by focusing on early detection and management of chronic disease, along with a more patient-centered approach to health care. POCT promotes these goals with rapid test results that providers can use to immediately inform patients of their condition or progress, and modify their treatment on-site. This provides a face-to-face opportunity to ensure understanding and discussion of future goals, thus more directly involving the patient in their own care.

Quality Management of Point of Care Testing

Saturday, June 09, 2018


With emerging technological innovations in healthcare, including smartphone apps, biosensors, lab-on-a-chip, and wearable devices—all of which offer a closer connection to the patient—point-of-care (POC) technologies are quickly becoming part of the transformation of the healthcare landscape. The driving concept in support of point-of-care testing (POCT) is to bring testing closer to the patient and results conveniently and quickly to the provider to expedite diagnosis and subsequent treatment. POCT allows for faster clinical decisions in hospitals, physicians’ offices, ambulances, patient homes, and in the field. 

The Protecting Access to Medicare Act (PAMA): Reduced Payments to Laboratories in 2018

Wednesday, May 09, 2018


The Protecting Access to Medicare Act (PAMA) includes the most extensive reform of the Medicare Clinical Laboratory Fee Schedule (CLFS) since it was established in 1984. Signed into law on April 1, 2014, PAMA was intended to introduce market-based pricing to the Medicare CLFS.  PAMA was passed after it was discovered by the Health and Human Services’ Office of Inspector General (OIG) that Medicare paid significantly more for clinical laboratory tests than commercial payers, and in some cases, Medicaid1. 

The Alternative Medicine Dilemma

Tuesday, May 01, 2018


Where does the average patient turn for medical advice? Well, between loaded online forums and databases, advice from friends and those dubious late-night infomercials touting miraculous benefits in \"just 30 days;\" health-conscious consumers have a wide spectrum of options, all claiming to help them manage their conditions. While all physicians hope that their patients seek trusted health authorities in their health matters. The reality is that the waters of what is and what isn't actually medicine gets cloudy for many patients. 

Spending Less is More Effective than Earning More

Tuesday, May 01, 2018


Most doctors have experienced running out of money before the month ends. Often, our first thought is the need to earn more money to make ends meet. But is increasing our income the best solution? Aren’t we already busy enough? Weren’t we just wishing we had more time off? Don’t we already make a lot of money?

5 Must-Haves For Great Physician Online Profiles

Thursday, March 01, 2018


Patients have a lot of choices when it comes to physicians.  Making sure your online profile is up to date, complete, and contains these five items will improve the chances that a website visitor will become a patient.

Ask the Expert - Do I need a CLIA license if I perform a lab test even if I’m not billing for it?

Thursday, February 01, 2018


The landscape for lab testing is changing and we must be able to adapt or go up in a puff of smoke! All is not doom and gloom, we can prevail.

Here are some tips related to testing, billing, etc.

Managing Type II Diabetes: The Role of the Laboratory

Tuesday, January 09, 2018


Diabetes is a worldwide epidemic. Its prevalence continues to rise globally at an average rate of 8.7 percent, and it currently affects 382 million of the world’s population. Significant increases in populations diagnosed with diabetes have been reported by many nations as their lifestyle and dietary norms evolve with globalization(1).