College of American Pathologists
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  For blood gas analyzers, improvements all around


CAP Today




August 2008
Feature Story

Anne Ford

Will more and more laboratory testing continue to be conducted near patients? Let’s put it this way: It’s sure not going to get any farther away from them.

“As the drive for improved patient safety and faster, better patient outcomes increases, in the coming years testing will continue to move closer to the patient,” says Bill Manchester, Instrumentation Laboratory group product manager. “Devices will have to guarantee laboratory-quality results at the point of care and transmit the correct patient information electronically with minimal operator effort.”

Among those devices: his company’s Gem Premier 4000 critical care analyzer, which represents a standard platform for centralized and decentralized point-of-care testing. Introduced last year, the analyzer uses a single, self-contained testing cartridge that users replace once every 30 days. Manchester attributes much of the instrument’s success to that ease of use. “Simplicity is the reason for the early success of the Gem Premier 4000. Laboratory-quality results can be achieved anywhere in the hospital, regardless of user skill level,” he says. IL shipped its 1,000th instrument worldwide this past June, he says, and the number of placements in large hospital systems continues to grow. In the near future, the company will launch bilirubin, BUN, and creatinine on the analyzer. The Gem Premier 4000 is, of course, one of several instruments in this month’s survey, which focuses on blood gas analyzers.

Siemens Healthcare ­Diagnostics’ blood gas news includes the announcement that it recently obtained 510(k) clearance for the neonatal total bilirubin application on its RapidLab 1245 and 1265 blood gas analyzers. The company plans to make the application available in the United States later this year, says Sheila Gavan, blood gas global marketing manager; it’s been available outside the country since January. “Reaction to the neonatal total bilirubin test has been very positive in that it is easy to use, requires no special adapters, and provides additional critical clinical information for the attending physician,” she says. Forthcoming developments will include updated software for the RapidPoint 400/405 and RapidLab 1200 series of blood gas systems: “These new versions of software will offer such enhancements as the ability for further operator customization, improved security options, additional demographic entries, and further connectivity applications between the analyzers and the Siemens Data Management system, ­RapidComm.”

At CAP TODAY press time, Radiometer was planning to introduce a CO-oximetry parameter set (pending FDA clearance) on its ABL80 Flex instrument at the American Association of Clinical Chemistry’s Annual Meeting and Clinical Lab Expo in Washington, DC. What makes the parameter set unique? “It incorporates the same proven co-ox technology found in Radiometer’s benchtop analyzers,” says Alan Beder, manager of scientific affairs. “This technology has become the gold standard for CO-oximetry measurement over the past 20 years.” Meanwhile, the ABL80 itself, as well as the ABL800, uses multi-wavelength technology. “Multiple wavelengths, combined with ultrasonic hemolyzation, eliminate common interferences and prevent deposits. Together, these technologies deliver accurate measurements and eliminate maintenance issues,” Beder says.

ITC has added lactate and creatinine testing to its IRMA TruPoint blood analysis system. Soon, the company says, it will also introduce new software that will provide enhanced oxygen and ventilator therapy settings documentation; users will be able to tag blood gas results according to the respiratory care given at the time of sampling. The software will also feature customizable reference ranges to allow users to define ranges by patient type, sample type, sample site, or department. And in the future, the company plans to adopt an isotope dilution mass spectrometry, or IDMS, traceable method for creatinine analysis.

Finally, Roche customers can look forward to a new analyzer in development that, says blood gas manager Larry Healy, will be designed to incorporate a censor for 12 test results that will be separate from the reagent pack. “This should allow for greater efficiency of reagent use,” he says. “For example, when reagents have expired before they are used, the whole pack—including the censor—has to be thrown away. If that should occur with the new analyzer Roche plans to develop, only the reagent pack would need to be thrown away.” The company continues to offer the Cobas B 221 blood gas system; designed for use in the ER, ICU, and other critical care environments, it offers testing for blood gases, electrolytes, tHb, O2Hb, HHb, COHb, MetHb, Hct, bilirubin, glucose, lactate, and BUN.

CAP TODAY’s survey of blood gas analyzers includes products from the aforementioned manufacturers and from Abbott Point of Care, Medica Corp., Nova Biomedical, and OptiMedical. Vendors supplied the information listed. Readers interested in a particular product should confirm that it has the stated features and capabilities.

Anne Ford is a writer in Chicago.

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