By Nicholas Borgert

Buoyed by the premise that faster testing and diagnoses translate into improved patient care, hospitals continue to invest in and utilize new point-of-care testing (POCT) products. This is done after weighing overall costs, consistency of results, and the projected volume of tests.

DCL’s ImmunoDip assays are urine-based testing devices for the detection of microalbuminuria.

The POCT sector, which includes intensive care units and products used at hospital bedsides, is expanding at the rate of 12%–16% every year, according to the Web site www.PointofCare.net. At this rate, according to the Web site, the domestic POCT market is projected to reach the $950 million mark by the end of 2005.

A range of chemistry reagents based on patented coenzyme analog technology is offered by Diagnostic Chemicals Limited.

Suppliers to the industry continue to develop new point-of-care reagents, handheld instruments, and portable systems capable of logging critical patient information at the bedside, moving it to a central hospital data management and retrieval system, and making it quickly accessible to clinicians and decision-makers.

Approaching With Caution
For most of the past decade, David Colard has been involved extensively with hospital point-of-care testing issues. He oversees POCT at St. Luke’s Hospital, the 2003 Malcolm Baldrige National Quality Award-winning hospital system in Kansas City, Mo.

His knowledge and expertise in the field earned Colard a coveted honor this summer when he was selected 2004 Point of Care Coordinator of the Year by the American Association for Clinical Chemistry’s Critical and Point of Care Testing Division.

According to Colard, studies using evidence-based medicine (EBM) may provide an additional tool in determining whether a specific point-of-care test is justified. Measurement of patient outcomes is difficult, so continued nonbiased studies using EBM may be helpful.

Colard says he first goes into an information-gathering mode when considering whether to add a new point-of-care test to his hospital’s offerings. He considers the goals of the test’s implementation and does an in-depth analysis of cost and connectivity issues.

“This must include projected volumes and cost per test, including wasted reagents, the time involved performing the test, and the time required for training and monitoring the test after implementation,” Colard says. Another key consideration is where the money will come from to pay for the device. If he is satisfied by his initial reviews, his next step is to ask for a hands-on demonstration of the POCT device. He always invites both clinicians and lab staff members to attend the demo.

Colard says POCT instruments most likely to satisfy user and regulatory compliance concerns offer these important features:

• User ID lockout.
• Quality control lockout.
• Data storage and transfer capability.
• Data management system compatibility. The device should either include a data management system, be compatible with multiple commercially available data management systems, or at minimum provide a user-friendly mechanism to import data into a spreadsheet format.
• Devices with built-in correlation features to provide a way of adjusting values to read as closely as possible to the reference method commonly found in the main laboratory.
• Room-temperature storage of testing cartridges or strips. Cartridges or strips that require refrigeration pose multiple problems. If reagents are kept refrigerated, they may need time to come to room temperature before they are used for testing. Reagent outdates commonly change when removed from refrigerated storage. Ensuring reagents are used within this new outdate can be difficult.
• Data management systems that provide connectivity to a variety of lab information systems. “Whenever possible, results should be made a part of the electronic record,” Colard says.
• Bar-code-reading capability. This should include compatibility with multiple bar-code symbologies and the ability to recognize invalid data.
• Down the road, built-in Ethernet adapters would be a plus.
       “The use of external devices, such as data ports, adds an extra device to maintain and troubleshoot,” says Colard. “Loss of connectivity due to data ports being unplugged or power strips being turned off is a chronic problem.”
• Wireless capability over a variety of connectivity and security protocols.

“Point-of-care devices need to be simple to operate, accurate, and able to detect preanalytical and analytical error due to operator error,” says Colard. “Whenever possible, there should be only a few operators who perform testing frequently.”

Faster turnaround is among the most common reasons for using POCT. To meet turnaround expectations for its Level I trauma center, St. Luke’s tubes its samples directly to the stat lab. “A tracker board located in the emergency department and stat lab aids in monitoring and communicating lab results to physicians,” Colard says. “Reducing transport and processing time, as well as automating the transmission of results directly to the physician, can eliminate the need to deploy additional point-of-care devices.”

Nova Biomedical
The point-of-care market has been the source of substantial revenue growth in recent years for Nova Biomedical (Waltham, Mass), says Director of Marketing Ron Newby. Nova Biomedical, he says, is now the only company in the world whose primary business is blood gas/critical care testing.

“Our five major competitors are all multibillion-dollar conglomerates whose blood gas/critical care sales are typically 1% or less of their business. Their blood gas business is so small that its success or growth is financially irrelevant to them,” Newby says.

Not so for Nova Biomedical. The company reported a more than 30% increase in POCT sales revenues last year, due largely to increasing demand for its Stat Profile Critical Care Xpress (CCX) analyzer. Newby says the CCX offers the broadest test menu, with up to 19 tests including creatinine, the blood urea nitrogen (BUN) test for measuring urea-produced nitrogen levels and ionized magnesium.

“This product exceeds the capability of all other POC analyzers to improve the outcome and reduce the cost of care,” Newby says. Higher levels of control and extensive connectivity options are among other key CCX features.

Nova’s wide variety of blood gas/critical care products has also been a driving force. According to Newby, his company offers 19 standard models of blood gas/chemistry analyzers based on CCX and Stat Profile pHOx mainframes. “Because Nova offers more models of blood gas/critical care analyzers than any other competitor, we can serve a broader range of hospitals and departments,” Newby says.

SmartCheck, a system maintenance product introduced by Nova last year, offers significant advantages in labor reductions. “It eliminates 80% of the time and labor associated with routine maintenance,” Newby says. “SmartCheck reduces time spent by an operator to just that time required to replace a calibration cartridge or maintain a biosensor.” The analyzer handles all processes required to restore the analyzer to “ready” automatically.

New product development at Nova continues to focus on analyzers that will improve the POC/critical care testing, with special emphasis on clinical needs for expanded menus, reduced labor and costs, and testing quality, Newby says.

Diagnostic Chemicals Limited
Based in Canada with US headquarters in Connecticut, Diagnostic Chemicals Limited (DCL) is a privately held manufacturer and supplier of chemicals, enzymes, and reagents to the diagnostic, biopharmaceutical, and life-science market segments.

Robert Janetschek, DCL’s director of business development, says his company has grown through successful partnerships with some of the country’s best-known diagnostics vendors. DCL offers a range of chemistry reagents based on a patented coenzyme analog technology (L3K®). The chemistry reagents incorporating L3K technology offer laboratories unique advantages: Significantly improved onboard reagent stability and less frequent calibration than competing products, he says.

DCL’s point-of-care products are concentrated on the diabetes/renal testing segment. The company offers its CLIA-waived (qualitative) and non-CLIA-waived (semiquantitative) ImmunoDip® assays, urine-based testing devices for the detection of microalbuminuria. First marketed in 1997, the ImmunoDip system is a lateral flow membrane-based technology. The company promotes it as the first self-contained, self-sampling test of its kind. Sales of the company’s rapid test for microalbuminuria have been on the rise in recent months in Europe and Asia, with orders also received from South Africa, Janetschek says.

To reach the US diabetes testing market, DCL has been marketing in partnership with one of the country’s leading test suppliers. The ImmunoDip platform can be used for urine tests for drug residue, hormones, and other proteins, as well as fecal-based tests for viruses.

“We are now researching other assays appropriate for point-of-care applications in hospitals and physician office laboratories,” Janetschek says. ImmunoDip devices offer a number of advantages over conventional test strips, he says. The strips are individually packaged, feature built-in controls for liquid migration and test completion, and their housing accepts patient ID information. DCL officials say the ImmunoDip system test results are unaffected by urine color, with results readable for as long as 8 hours.

The veterinary testing market has been a key area of growth for DCL, Janetschek says. Modified versions of the ImmunoDip device experienced a drastic increase in sales during the past year. “Sales are up tremendously when compared to our last fiscal year,” he says. “Animals require diagnostic testing, too. There are reference laboratories that deal exclusively with animal samples. The veterinary testing market segment offers us a significant opportunity.”

i-STAT/Abbott Point of Care
A year ago, i-STAT was scheduled to regain autonomy after a 5-year distribution agreement with Abbott. Then Abbott decided to acquire i-STAT and roll its core hospital glucose business into a new division: Abbott Point of Care.

“Many people see this union as quite logical and exciting with i-STAT’s extremely entrepreneurial culture in point of care and Abbott/Medisense representing a solid sales foundation with vast resources,” says Michael F. Corsello, senior marketing manager.

Abbott Point of Care formally launched the i-STAT Troponin I, a 10-minute bedside test, in June of this year. The test/platform is billed as the first portable handheld device to offer chest pain triage and risk stratification with lab-grade analytical performance.

The ACC/AHA guidelines recommending a cardiac marker turnaround time “of preferably 30 minutes” has led to heightened awareness by emergency department physicians of the benefits a 10-minute result can make to care pathways. The i-STAT handheld offers a complete testing portfolio (blood gases, electrolytes, chemistry, and coagulation), making it a popular choice for stat ED diagnostics, Corsello says.

Acquiring timely diagnostic information will grow even more important in the future as therapies and surgical and pharmaceutical interventions become even more aggressive. Corsello expects instrument consolidation to increase as the market recognizes the value of using a single-platform POCT to meet challenges hospital-wide.

He says evidence-based medicine will continue to be critical in bedside diagnostics. “What must be understood is how difficult some of these studies are to complete with clear outcome and without bias,” Corsello says. He points to anticoagulation management as an example of this.

Cardiovascular operating room (CVOR) outcome studies are extremely complicated and detailed, and potentially create more issues than answers, he says. It is almost impossible to standardize patients, disease state/progression, and surgical team practices to specifically show product A is better than product B.

“Handheld bedside testing will continue to be the ultimate iteration of improving turnaround time; wherever the patient is located, diagnostic testing can be performed in minutes,” Corsello says.

Nicholas Borgert is a contributing writer for Clinical Lab Products.