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Rising incidences of infectious disease and chronic conditions spell gold mine for the global point-of-care market
By Robin Hocevar, WWW.ADVANCEWEB.COM • ADVANCE/LABORATORY • JUNE 2015

While tea leaves suggest another slow year for the American economy in 2015, the global point-of-care market is another story altogether.

According to Ryan Schmidt, vice president of infectious disease marketing at Alere, projections of the global POC diagnostics market over the forecast period of 2013 to 2018 say it’s poised to grow at a CAGR of 9.3% percent from 2013 to 2018, to reach $27.5 billion by 2018. Schmidt said North America holds the largest market share, but Asia and Latin America should also experience high growth.

“This large share is primarily attributed to the huge and increasing addressable patient population base. Moreover, the development of accurate and rapid testing kits is further fueling the growth of the POC diagnostics market in North America,” he noted. Specifically, the global POC diagnostics market is categorized into several segments, such as infectious diseases testing kits, glucose monitoring kits, coagulation monitoring kits, urinalysis testing. Read more - note, this article begins on page 27 >

Pressing Questions in POC Glucose Testing

CAP Today, April 2015, By Kevin B. O’Reilly

Sometimes major changes to a health care organization’s point-of-care testing system come from powerful regulatory agencies in Washington, DC. Or they may arise when a child with diabetes objects to frequent venipuncture. In either kind of case, experts say, pathologists and laboratory professionals must form strong relationships with clinicians and build structural foundations to help them meet these and other demands.

“If you intend to make claims for use of your meter in populations that are particularly vulnerable to potential interferences, you should include patients in surgical and medical intensive care units,” the guidance said. “To collect performance data in such populations, each study should include at least 50 patient samples from the surgical ICU and 50 patient samples from the medical ICU.”

The draft guidance, available at http://j.mp/fdabgms, has drawn dozens of comments—mostly negative—from physician organizations and other stakeholders concerned about its potential impact. Among those objecting is the CAP.

The FDA has not yet taken action to finalize or otherwise alter its draft guidance. Read more >

Glucose Meters in Critically Ill Patients: What New Guidance Means for Labs
Clinical Laboratory News, By James Nichols, May 2015

What is all the buzz about use of glucose meters in critically ill patients? Glucose meters have been used for more than 30 years to provide rapid measurement of glucose on whole blood fingersticks from patients with diabetes. Originally developed for patient self-testing, glucose meter use has expanded throughout the healthcare industry. Meters currently are being used in physician offices, schools, nursing homes, ambulances, helicopters, airplanes, and cruise ships. Glucose meters have even traveled on the Space Shuttle! They are common throughout hospitals and are used for a variety of reasons, from quick checks of glucose levels to hourly glucose level monitoring as part of intensive insulin protocols.

So, why is there now a concern over the use of glucose meters? Problems with glucose meters have been known from the start. Glucose meters designed for patient self-monitoring are validated primarily on ambulant, well patients who happen to have diabetes. These meters are calibrated for normal hematocrits and physiology.

 

Read more >

Performance Evaluation of a Glucose Monitoring System for POCT With Critically Ill Patients

A Multicenter Study
Louie, Richard F. PhD, FACB, Point of Care: The Journal of Near-Patient Testing & Technology: March 2015

The purpose of this study was to evaluate the performance of the ACCU-CHEK Inform II glucose meter system for use in critically ill patients, and to assess the effects of blood oxygen tension, hematocrit, sodium levels on glucose measurements.

A multicenter study involving the collection and testing of remnant de-identified whole blood samples from the blood gas laboratory at 3 institutions. Glucose meter measurements were compared to the Hitachi/Cobas c501 Isotope Dilution Gas Chromatograph aligned glucose hexokinase reference method, and the hospital’s laboratory comparison method. Blood gas, whole blood electrolyte, glucose, and hematocrit test results were documented for each sample.

 

More on this abstract...

 

Note, to access this article you need to subscribe to Point of Care: The Journal of Near-Patient Testing & Technology.

Study, Strategy Lift up Point-of-Care Critical Value Practices
By Ann Griswold, PhD, CAP TODAY, www.captodayonline.com

Too many point-of-care glucose test results in the critical high and low ranges may be nonreproducible and therefore should be repeated.

 

That was the finding of a study published last year that said POC glucose results in the critical ranges should be considered to have a relatively high probability of signaling a potential preanalytic error. The retrospective analysis of POC glucose testing in routine patient care settings found that as many as half of all critically high or low test results, when repeated, were not so critical after all (Schifman RB, et al. Arch Pathol Lab Med. 2014;138:962–966).

“The lesson we learned is that you need a strategy for confirming, verifying, and reporting critical point-of-care blood glucose values,” says lead author Ron B. Schifman, MD, chief of diagnostics for the Southern Arizona VA Healthcare System, Tucson, and vice chair of the CAP Quality Practices Committee. He hopes such studies will help others become aware that critical values must be addressed in the point-of-care setting just as they are in the laboratory setting. Learn more >

Preventing an Outbreaks
Point-of-care testing can help manage and contain an infectious disease outbreak

By Rebecca Mayer Knutsen, Advance for Administrators of the Lab

Early detection of infectious diseases such as HIV/AIDS and TB can lead to an improved disease outcome. As a result of the recent Ebola scare, experts are hoping point-of-care tests (POCTs) will play an important role in handling potential infectious disease outbreaks.

In a 2013 study published in Biomarkers in Medicine titled "Point-of-care testing and the control of infectious diseases," study authors Khayriyyah Mohd Hanafiah, Mary Garcia and David Anderson stated "the uptake of an accurate test that is simple, rapid and robust can significantly alter the epidemiology and control of the disease." Learn more >

The Lab's Role in Patient-Centered Care
How proactive is your staff in becoming an integral part of the new healthcare team?

By Stephanie Mihane, MLS(ASCP)cm, POCS(AACC), Advance for Administrators of the Lab

 

Point-of-Care Testing
I became interested in the "catch phrase of the day" - patient-centered care - as my responsibilities as a point-of-care coordinator evolved beyond my original perception of the role. I was to provide regulatory guidance, technical expertise and ensure that the many departments within my organization that required reliable, timely and quality testing by non-laboratory personnel was provided in an efficient, economical and satisfying means to our patients.or at least that's what I thought it was.

A New Light

It's time for laboratorians to "get out of the basement" and become an integral part of the healthcare team and patient-centered care. I work for Kaiser Permanente, Colorado Region, and we advocate the total health of our members and communities. At Kaiser Permanente, we see ourselves as a health advocacy organization. We are here to help the patient get the most out of his/her journey toward total health - a journey that is different for every single person we encounter. Learn more >

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