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New Vendor Listing...

Magellan delivers a complete line of FDA-cleared blood lead testing systems...
More >

CLSI Releases Standards on


CLSI recently released new and revised standards on point-of-care testing in relation to glucose measuring and monitoring. Effects of Different Sample Types on Glucose Measurements,

1st Edition (POCT06-Ed1), provides information to assist the clinical and point-of-care staff in result and measurement procedure comparisons of glucose tests. More >

Assessing New Molecular Influenza Tests
Clinical Lab Products, November 2015, By Sheldon Campbell, MD, PhD, FCAP, and Norman Moore, PhD

Following best practices can help labs maximize the utility and cost-effectiveness of flu testing.

Screening for influenza infection may be important for improving patient outcomes and reducing the public health impact of this potentially deadly illness. Yet, despite the availability of dozens of influenza testing devices, most such tests do not realize the full potential of diagnosis because they do not provide highly accurate results quickly enough for healthcare providers to make informed treatment decisions while the patient is still under their care.

The combination of suboptimal diagnosis, the highly transmissible nature of the virus, and the wide overlap of symptoms with more urgent conditions like pneumonia, has led to widespread empirical treatment, and sometimes overtreatment, of patients who present with influenza-like illness. More >

The "Tricorder" of Patient Care
From glucometers to genetics and the future of testing
By Silas Gossman, October 26, 2015, Advance for Administrators of the Laboratory

The healthcare paradigm is moving rapidly toward point-of-care testing (POCT) in several areas. With this dramatic move, however, there are several issues to take under consideration. The benefits entail such things as increased timeliness of results and convenience for patients. Among the potential issues, however, are the possible costs of these tests, the reliability of the machines and the standards of quality and regulations hospitals must work to meet with the added equipment.


This article follows the thoughts of several experienced practitioners in the field of POCT, including Mark Crowther, MD, at McMaster University, Kim Gregory MT (ASCP), NCA, CLS, Associate Director, POCT at Massachusetts General Hospital and Lara Moody, MLT (ASCP), coordinator of POCT at Dartmouth-Hitchcock Medical Center in Lebanon, NH.

Q&A with Kimberly Gregory:
ADVANCE: In what fields do you see POCT having the most untapped potential applications? More >

Note: Parts 1 and 3 of this article can also be accessed on the Advance for Administrators of the Laboratory website.

Point-of-Care Testing Continues Growth
Greater Speed and Accuracy Mark POC Trends
By Gary Tufel, Clinical Lab Products

Sometimes referred to under the heading of “near-patient” or “bedside” testing, point-of-care (POC) diagnostics encompass a variety of test platforms that sometimes appear to have very little in common with one another. What they do have in common is their focused ability to provide simple, rapid testing, often of blood or urine samples, and to be administered physically close to the location of the test subject. Some are administered in medical settings, and some at home; some are simple kits meant for use in settings where electricity and other resources might not be readily available, and some are sophisticated instruments with broad information technology capabilities. More >

PRIDE Statement on the Need for a Moratorium on the CMS Plan to Cite Hospitals...

...for Performing POC Capillary Glucose Monitoring on the Critically Ill
David C. Klonoff, Boris Draznin, Andjela Drincic, Kathleen Dungan, Roma Gianchandani, Silvio E. Inzucchi, James H. Nichols, Mark J. Rice, and Jane Jeffrie Seley, J Clin Endocrinol Metab

A writing committee of the Planning Research in Inpatient Diabetes (PRIDE) group has
written this consensus article on behalf of the group in response to a specific request for input from the Centers for Medicare and Medicaid Services (CMS). The purpose of this article is to respond to the March 13, 2015 statement from that agency regarding plans to enforce prohibition of the off-label use of point of care (POC) capillary blood glucose monitor (BGM) testing in most critically ill patients. The article discusses:

  1. How POC BGM testing is currently regulated;

  2. How POC BGM testing is currently used in the United States; and

  3. How POC BGM testing can be safely and effectively regulated in the future through cooperation between the clinician, laboratory, regulatory, industry, and patient communities.

For more on this article, visit the The Journal of Clinical Endocrinology & Metabolism

(JCEM). Please note that JCEM requires a subscription to this article's content.

Full-court Collaboration in Transition to IQCP
By Anne Paxton, CAP Today, September 2015

With the CLIA Individualized Quality Control Plan process geared to unseat the familiar Equivalent Quality Control process on Jan. 1, there seems to be wide agreement that microbiology laboratories will have the biggest adjustment to make to comply with CLIA QC requirements, despite the IQCP being voluntary.

“IQCP will have a more profound effect on clinical microbiology than some other areas of the lab that already run positive and negative controls every day they run tests,” says Susan Sharp, PhD, president-elect of the American Society for Microbiology and a member of the CAP Microbiology Resource Committee.

Janet A. Hindler, MT(ASCP), also a committee member and a senior specialist in clinical microbiology at UCLA Medical Center, says, “We will either be preparing IQCPs or we will revert to following CLIA regulations developed in ’88, despite the fact that for several commonly employed clinical microbiology tests, CMS recognized several decades ago that there were less stringent alternatives for QC of these tests.”   More >

Decentralized Coagulation:

The role of POCT in the diagnosis of clotting disorders
By Michael Jones, Advance for Administrators of the Lab, Vol. 24 • Issue 9

When it comes to a blood clot, every second matters. Clotting conditions like deep vein thrombosis (DVT) or venous thromboembolic (VTE) disorders pose significant concerns as morbidity and mortality from complications like a stroke or pulmonary embolism are a very real threat. Clinicians and physicians must be able to determine the clotting factors in a patient's blood with speed and accuracy. In a recent interview with ADVANCE, American Society of Hematology (ASH) spokesperson Roy Silverstein, MD, professor and chairman of medicine at the Medical College of Wisconsin, senior investigator at the Blood Research Institute at the Blood Center of Wisconsin, discussed the benefits and limitations of point-of-care testing (POCT) in the diagnosis of coagulation disorders.

"In general, point-of-care testing has gotten a whole lot better now than it was 10 years ago, but still, it suffers by comparison to the laboratory-based test in terms of the accuracy and precision," said Silverstein. More >

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