College of American Pathologists
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  Aiming for lab-like accuracy at the point of care


CAP Today




April 2009
Feature Story

Brendan Dabkowski

American frontiersman and gunslinger Wyatt Earp is credited with the gem “fast is fine, but accuracy is everything.” Though physicians at the point of care are unlikely to find themselves in an Old West-style gunfight, most, like Earp, would choose accuracy over speed. And that means makers of bedside glucose testing systems must be ever vigilant in meeting customers’ requests for improved accuracy.

“The primary need for clinicians using POC glucose monitors is that they give accurate results—even in the presence of interfering substances like maltose, abnormal hematocrit, ascorbate, etc.—so that correct treatment decisions can be made,” says Ron Newby, Nova Biomedical’s director of marketing. Also crucial: obtaining the right glucose read the first time, at the point of care, to eliminate the “time-wasting need for repeat measurements,” he says. Analyzers must deliver results quickly, but without sacrificing accuracy. Hospitals now face the “need to provide even higher levels of accuracy in handheld devices, in effect delivering lab-like accuracy at the bedside,” says Mary Catherine Coyle, MS, MT(ASCP), director of product marketing in the professional diagnostics division of Roche Diagnostics.

Making their systems easier to operate and more accurate, improving testing processes, expanding wireless capabilities, and more are what the companies in this month’s CAP TODAY product guide are aiming to deliver.

Nova’s StatStrip Multi-Well test strip measures hematocrit and other interfering substances and corrects for their interference effect, Newby says, adding that StatStrip technology has been validated in 23 published clinical studies throughout the world to provide interference-free lab-like accuracy. Similar to Nova’s StatStrip glucose meter is the company’s new StatSensor creatinine monitor with eGFR. Introduced last year, StatSensor is a handheld analyzer for whole blood creatinine testing that “incorporates the same Multi-Well technology as our StatStrip glucose monitor to enable simple, rapid, and accurate assessment of renal function at the point of care,” he says. This summer, Nova will offer a wireless connectivity sol­ution for the StatSensor and StatStrip analyzers. It will permit rapid patient data charting and facilitate use in insulin dosing algorithms, Newby says. It will also enable continuous ADT and facilitate manual test entry.

Other systems profiled in CAP TODAY this month include Abbott Diabetes Care’s Precision Xceed Pro blood glucose and β-ketone monitoring system, which was introduced late last year. The system is designed to help protect patient safety by minimizing the chances for errors in bed­side testing and helps insti­tutions monitor patients at risk for diabetic ketoacidosis, says Peter Kar­kantis, general manager in the company’s hospital and government division. “The Precision Xceed Pro system is the only point-of-care system, among the leading brands, that tests both blood glucose and blood ketone,” he says. It is for use with Precision Xceed Pro β-ketone test strips, which measure β-hydroxybutyrate.

The Xceed Pro also offers a rapid identity confirmation technology called TrueID patient identification, and the system incorporates TrueMeasure strip technology, a feature intended to minimize interference from more than 65 medications and substances, including maltose. TrueAccess information technology, another system feature, uses the company’s PrecisionWeb point-of-care data-management system, which is designed to help improve collaboration among point-of-care professionals, help improve glycemic control performance, and simplify and streamline point-of-care testing compliance. The company’s wireless connectivity solution for the Xceed Pro, Karkantis says, makes it possible to transfer test results wirelessly to the patient’s electronic chart, helping to make bedside test data available to physicians rapidly.

New from LifeScan is the OneTouch DataLink Wireless V3 connectivity solution, which provides data transfer from the company’s SureStep Flexx glucose meter. Introduced in January, Wireless V3 allows data to be “transmitted immediately from the site of testing to where the data needs to go, so patient decisions can be made and the patient can be better cared for,” says Theresa Vaughan, LifeScan marketing manager. The unit has “the highest level of security in data transmission, so data integrity is maintained,” she says. The company also released in January versions 3.3 and Web 2.0 of its OneTouch DataLink data-management software, which are capable of residing on the latest operating systems. “Our customers must keep up with the latest database and operating systems, and LifeScan’s data-management software supports these upgrades,” Vaughan says. The OneTouch DataLink software supports SQL 2005/2008 database, Microsoft XP/Vista and MS Server 2003/2008, and Citrix. Through a partnership with a third-party vendor, Telcor, operator certification can be input and stored in the QML system, a point-of-care hub, and pushed down to the SureStep Flexx meters for greater nursing efficiencies.

Vaughan notes the importance of off-meter dosing (which LifeScan offers), a method of testing that enables hospitals to address the transmission of infectious agents, especially those not readily treated with antibiotics. “Rather than placing the strip into the meter and bringing that strip and meter to the patient at the bedside, exposing the patient to the meter, the only thing that goes to the patient is the strip, and then the strip goes into the meter away from the patient,” Vaughan says.

Arkray USA plans to launch this year its Assure Platinum blood glucose monitoring system. The system, which will include a no-code feature, is an upgrade to the Assure Pro meter, says Michelle Dumonceaux, senior marketing manager in Arkray’s long-term care division.

Many of the systems in this month’s lineup will be familiar, among them Roche’s Accu-Chek Inform line of blood glucose meters. Roche in 2004 made an update to strengthen the system’s patient identification function, which works in conjunction with Medical Automation Systems’ Rals-Plus data-management module. “This capability,” Coyle says, “provides two unique patient identifiers to help ensure patient safety and help health care facilities comply with the Joint Commission’s No. 1 patient safety goal” for hospitals, which is improving the accuracy of patient identification. The Inform system also extends the level of regulatory compliance and documentation capability of blood glucose testing to six other manual POC tests, including pregnancy and fecal occult blood.

Roche has submitted for FDA 510(k) clearance its Accu-Check Inform II next-generation blood glucose monitoring system; it is pending review.

CAP TODAY’s product guide (PDF, 122 K) for bedside glucose testing systems includes products from the aforementioned manufacturers and from HemoCue, International Technidyne, Medtronic MiniMed, and YSI Life Sciences. Companies supplied the information listed. Readers interested in a particular product should confirm it has the stated features and capabilities.

Brendan Dabkowski is CAP TODAY associate editor.

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