By Gary Wolfe

The CCX analyzer is a consolidated workstation that provides a standard array of 19 on-board blood gas, CO-Oximetry, hematology, electrolyte and chemistry tests – including ionized magnesium, BUN and creatinine. Besides providing a choice of seven standard menus for regimens of three to all 19 tests, the analyzer frees users to develop custom menus according to their particular test requirements.

The small footprint of the CCX makes it easy to incorporate into a lab of any size or to use as a mobile unit, easily transportable anywhere within a hospital via an optional cart.

Additionally, the analyzer is highly automated to facilitate testing, calibration, self-diagnosis, and maintenance with minimal human intervention. This allows a wider spectrum of users with different skill sets to use the same system. Operators could include medical technologists, respiratory therapists, RNs, anesthesiologists or perfusionists, as examples.

Comprehensive on-board test suite
The CCX was designed to provide the critical care tests most often ordered by clinicians to assess the status of unstable patients. Measured tests include: blood gases (pH, PCO2, PO2, SO2%) hematology (hematocrit and hemoglobin), electrolytes (Na+, K+, Cl-, Ca++, Mg++), chemistry (glucose, BUN, creatinine, and lactate), and CO-Oximetry (t HB, HHb, O2Hb, MetHb, and COHb). Calculated results include oxygen content (O2Ct), oxygen capacity (O2Cap), bicarbonate (HCO3), TCO2, PO2/FIO2, anion gap, BE-ecf, BE-b, A, A-aDO2, RI, a/A, SBC, base excess, BUN/creatinine ratio, Ca++/Mg++ ratio, normalized Ca++, normalized Mg++, osmolality, oxygen saturation and hemoglobin. All analytes carry CPT codes to facilitate cost reimbursement.

Lloyd Adams, Nova Biomedical director of corporate marketing and new product development explains that typical diagnostic applications include measuring critical patient functions such as acid-base balance, ventilation, perfusion, renal function, electrolyte balance, contraction, conduction, cellular energy, and osmolality. According to Adams, “The analyzer provides results that correlate well with reference methods. The user can also enter X and Y correlation factors to ensure consistency with any other analyzer or methodology.”

Intuitive Operation
Training a laboratory or clinical staff member to use the CCX takes only about 30 minutes. Operators see and act upon video prompts via a color touch screen, with settings customized by a laboratory or respiratory care department, an OR, or an ICU. Departments can set their own operating rules and configure each of the four primary screens to contain required data fields in a specified order. Users can determine the order in which results are displayed, and can program age and sex specific normal ranges, as well as panic ranges. All ranges can carry preset warning flags.

Operation is straightforward: draw a heparinized blood sample from the patient (sample size is 50 ?l for a blood gas panel and 200 ?l for all 19 measured tests); select the desired test panel on the touch screen; select the type of sample container being used (syringe or capillary); enter any required patient or accession number; press the “analyze” key; and view, print, or transmit the results to the LIS or HIS. Mode A (high throughput) provides results in 65 seconds, or Mode B (routine throughput) in 140 seconds.

On-Board Data Management
Users can interact with on-board data management tools to provide data capture, storage, and reporting in five areas: patient results and full demographics, quality control data, instrument performance and maintenance data, operator data, and analyzer set-up and configuration data. Adams says, “The data management system allows flexibility to further customize the analyzer, and simplifies the process by providing a comprehensive on-board library, a full suite of built-in and customizable reports, and a toolbox to access stored data.” Both tabular and graphic trend data reports are available to facilitate review of patient status.

Integration with HIS and LIS
Depending on the hospital’s data management and billing requirements, the analyzer can be set up to send data directly to the LIS or HIS by a variety of transmission methods. The analyzer meets the new NCCLS-POCT-1A standard to assure “plug-and-play” connectivity with multiple instruments from different vendors. Nova also offers Remote Testing Manager software, which allows multiple analyzers (CCX and other makes) to connect with the LIS or HIS through a single interface. This gives an operator at one central workstation a real-time view of status information for any analyzer in the network and remote control of maintenance and QC functions. The Windows 2000 desktop allows the addition of extra printers, faxes, remote monitors, Ethernet and Internet connections, and communication devices, such as telephone modems and paging devices.

Automated Maintenance and QCThe CCX is designed to avoid time-consuming aspects of maintaining a critical care analyzer. “The CCX user can perform simple component replacements and literally walk away,” says Adams. “The analyzer automatically refreshes its fluids, equilibrates its sensors, performs calibration, runs quality control, logs the data at optimal times, and returns to a steady state without further user intervention.” This reduces analyzer downtime.

The analyzer also automates QC procedures. Snap-in cartridges contain multiple levels of pre-assayed blood gas, chemistry, and hematology controls. No operator intervention is required beyond inserting the cartridge at which time all QC ranges, lot numbers, and expiration dates are uploaded.

An optional QC lockout feature ensures that patient results are reported only for tests performed while the instrument controls were in range. If a QC test falls outside of its specified range, the analyzer can lock out that test until it is within range. Optional alarms and auto-paging can alert a key operator that a test lockout has occurred.

Disposable Calibration and QC Packs
One snap-in reagent pack contains all required liquid and gas calibrators, as well as a sealed waste container that stores sample and reagent waste. These packs are replaced every 30 to 45 days, and external fluid pump tubes annually. Some sensors are disposable and need replacement on a schedule ranging from weekly to annually.

When a user plugs the reagent and QC pack into the analyzer, all calibrator values, fluid volumes, and expiration dates automatically download to the computerized reagent management system. Fluid consumption is then monitored automatically and calibration reagent levels are displayed on-screen.

The Nova Stat Profile Critical Care Xpress analyzer combines two instruments in one – a blood gas analyzer and a CO-Oximeter. Chemistry and hematology parameters round out the test menu to make it an “all-in-one” analyzer designed for critical care testing needs.

Gary Wolfe is a freelance writer based in Franklin, Massachusetts.