Delivers Results in Fewer Than 13 Minutes
Wartime conjures up graphic images of the ultimate point-of-care scenario—life-and-death situations necessitating instant diagnostic and treatment decisions by battlefield medics. Indeed, current newspaper and other media accounts (eg, “Combat Wounds Proving Less Deadly.” Boston Sunday Globe. August 31; 2003, A1, A29) attribute improvements in battlefield medicine with saving a higher percentage of American soldiers’ lives in Iraq than in any previous war. In part, this results from the effectiveness of well-equipped forward surgical teams that move along with the troops and dramatically reduce the time needed to diagnose and treat war wounds.
The Abaxis Piccolo point-of-care blood chemistry and electrolyte system is a fully automated, broad-menu, benchtop analyzer. The inset photo shows the single-use reagent disk, which carries an array of analytes composing a complete test panel.
As is often the case, technologies employed for wartime applications tend to extend to the mainstream civilian sector. One such example is the Abaxis Piccolo® point-of-care blood chemistry and electrolyte system. Based on a proprietary enzymatic test technology originally developed for the NASA space station program, this compact, labor-saving system has been deployed by the medical corps of all American military forces since the mid-1990s and is currently in frontline use in Iraq and Afghanistan. Many civilian medical institutions in the United States and abroad have also adopted it.
A Fully Automated, Broad-Menu Benchtop Analyzer
The fully automated, broad-menu Piccolo analyzer employs a combination of spectrophotometry, centrifugation, and disposable clear-plastic reagent disks, each of which provides a complete panel of up to 14 individual tests. Quantitative, laboratory-equivalent results in the form of measured concentrations are delivered in 15 minutes, including hands-on time, and only a few drops of whole blood, serum, or plasma are required.
According to Ron Blasig, director of marketing for Abaxis Inc, headquartered in Union City, Calif, the Piccolo analyzer offers a combination of attributes that appeal to both military and civilian markets: broad applicability, predictable accuracy, speed, ease of use, dependability, robustness, portability, and low maintenance. Blasig’s colleague Patricia Woods, MT, director of medical sales, says, “Feedback from both military and civilian user communities has been very positive, especially with regard to ease of use and reliability. It’s amazing how well these analyzers adapt to different needs . . . hospitals, outpatient clinics, trauma units, family practices, oncology units, neonatal ICUs, imaging centers, ambulances, paramedic vehicles, and more. Time is so precious when making treatment decisions. It’s all about providing results quickly while the patient and caregiver are together.”
Reagent Disks Carry Comprehensive Test Panels
Each single-use Piccolo reagent disk carries an array of analytes composing a complete test panel. Currently available panels include general chemistries, electrolytes, lipids, basic and comprehensive metabolic, renal, and hepatic. New panels continue to be developed. The disks come in convenient 10-packs, one disk per sealed foil pouch. Normal mode of storage is under refrigeration, although disks may safely be held at room temperature for up to 48 hours as long as the pouches remain sealed until the time of use. When the pouch is opened, the exposed disk must be used within 20 minutes.
To prepare a disk for testing, the operator simply opens the foil pouch and transfers the sample (100 µ of whole blood, serum, or plasma) into a fill port in the disk’s sample chamber. Fill marks on the disk indicate when an adequate sample volume is present. An overfill chamber in the disk collects any excess. If a disk carries an insufficient sample volume, the analyzer’s intelligent quality control (iQC) system senses the underfill and rejects the disk.
Small Footprint, Lightweight, and High Mobility
The Piccolo analyzer is about the size of only a kitchen toaster: 9.5″ H x 6″ W x 11.5″ D (24.2 cm x 15.2 cm x 29.2 cm). It is also relatively lightweight: 15 pounds (6.9 kg), plus 1.3 pounds (0.6 kg) for the power adapter. A recessed carrying handle is built into the unit, and a hardshell case is available for safe transport in mobile applications. Power requirements are 120–240 volts AC, 50–60 Hz, or 12-–15 volts DC. The unit has a short warm-up period during which it self-tests to ensure optics, flash lamp, circuit board, and memory functions while optimizing operating temperature. Woods says, “The small size makes it ideal for physicians’ offices, clinics, emergency rooms, decentralized labs, and central labs where it can serve as a backup to full-sized blood chemistry and electrolyte analyzers.”
Operation Eased by Simple Menu Prompts and Onboard Quality Control Checks
Typical users for the Piccolo analyzer cover the spectrum from licensed medical technologists to registered nurses, to physicians. Although it is currently classified as a moderately complex (nonwaived) instrument, the manufacturer is pursuing CLIA-waived status for lipids because of its inherent ease of use.
The procedure for using the Piccolo analyzer involves three basic steps: 1) Add the sample to the reagent disk, 2) Insert the disk into the drawer in the analyzer, and 3) Read the results in fewer than 13 minutes. Blasig says, “Using the analyzer is very intuitive and user-friendly, essentially plug-and-play. We provide a brief instructional CD and routinely train users in a couple of hours, either face-to-face or by phone.” Abaxis also provides a free telephone hotline for technical support.”
During operation of the analyzer, 100 quality control checks run automatically on the sample to ensure integrity of test results. The unit also self-calibrates automatically for each run. An onboard liquid crystal display (LCD) reads out screen prompts to facilitate operation. A keyboard enables entry of data pertaining to the operator, physician, patient, tests, date, time, and more. The system is preprogrammed with standard reference ranges; however, it is easily reprogrammed for other ranges as necessary.
Test Results Output in Hard Copy and Electronic Formats
The Piccolo analyzer’s memory can store test data for up to 70 patients and 70 control values. A built-in printer outputs hard-copy reports (ie, demographic background of the patient, results, corresponding reference ranges, quality control information, and sample integrity data) onto special 6″ x 2″ paper cards; peel-off backings allow the cards to self-adhere to other documents or the patient file folder. The analyzer can also transmit stored results in ASCII 2-4 format to the institution’s Hospital Information System/Laboratory Information System (HIS/LIS) via a standard RS232C port to facilitate online patient recordkeeping and billing for the reimbursable tests.
Excellent Correlation With Central Lab Results
Abaxis can furnish a variety of published technical papers attesting that results obtained by the Piccolo benchtop analyzer correlate well with central laboratory chemistry analyzers. For example, a NATO Supreme Headquarters Allied Powers Europe laboratory study reported in 2000 the following representative correlations by analyte between the Piccolo and the Kodak Ektachem clinical chemistry system: glucose (100%), urea nitrogen (BUN) (99.8%), creatinine (99.9%), creatine kinase (CK) (98%), sodium (Na+) (99.7%), and potassium (K+) (98.8%).
Another study, conducted in 2002 by the Oregon Health and Science University, compared results from the Piccolo analyzer with results from the Beckman LX-20 analyzer. For a series of simultaneous analyses run on duplicate sets of 60 human samples, the study showed an almost perfect correlation between the two instruments.
Availability and Cost Factors
According to Blasig, the Piccolo point-of-care blood chemistry and electrolyte system is approximately one third the cost of other popular benchtop analyzers used in physicians’ offices. The unit is ready to use out of the box; no special setup or installation is required. The only recurrent costs are for the reagent disks, the prices of which depend on volume and panel type. No calibration reagents are required. Telephone technical support is free. In the event a Piccolo analyzer must be returned to Abaxis for service, the company will immediately ship a loaner unit for use until the customer’s analyzer is returned.
Gary Wolfe is a contributing writer for Clinical Lab Products