By Gary Wolfe
ABX Diagnostics’ Paros CRP analyzer facilitates rapid clinical decision-making
CRP analysis allows clinicians to assess the severity of an inflammatory response, as well as to distinguish between viral and bacterial inflammation in certain settings. According to Dr. Ian Giles, manager of scientific affairs for ABX Diagnostics of Irvine, Calif., “A rapid quantitative CRP result provides clinicians with early diagnostic information, which allows more timely decision-making. This was a key motivation for developing the PAROS CRP analyzer.”
ABX Diagnostics’ Paros CRP analyzer
Designed to facilitate CRP screening for any type of inflammation and to speed patient workflow, this compact, bench-top point-of-care analyzer quantifies C – Reactive Protein in an 8 µl sample of whole blood or serum in less than five minutes. “Our CRP test,” says Giles, “is designed to screen for the presence of significant inflammation and to enable early patient management decisions to be made with confidence. With linearity down to 0.2 mg/dl, we can detect all significant inflammation and thereby facilitate this decision-making.”
“We are commonly asked if our instrument is sensitive enough for cardiac risk stratification,” Giles continues. “We do not make those claims, and that is not the intended function of this analyzer. Cardiac risk stratification requires patients to be free of inflammation other than the underlying atheromatous inflammation. The CRP levels are within the normal range for CRP, and the interpretation of results ‘relies’ on this. The presence of significant, non-atheromatous inflammation complicates interpretation of the risk assessment. Furthermore, CRP analysis for cardiac risk assessment requires additional, more cardiac-specific panels to be included in the evaluation.”
The test methodology employed by the Paros CRP Analyzer is CRP latex immunoturbidimetry. Giles says, “Our ability to measure CRP in whole blood eliminates the need for sample centrifugation or transportation and yields results in 4 minutes and 20 seconds for each screening performed. Results correlate well to those expected in a central laboratory.” For example, drawing a comparison to a Beckman Immage instrument, he reports a co-efficient of determination: R2 = 0.99.
He states that the linearity range is 0.2-10 mg/dl for whole blood, and 0.2-7 mg/dl for serum. The lower limit of detection was previously found to extend down to 0.1 mg/L on the Micros CRP (which employs the same CRP module). As a reference, he cites Clinica Chimica Acta 314(2001) 255-259 Performance Characteristics of a Point of Care C-Reactive Protein Assay; William Roberts, Elisabeth L. Schwarz, Shake Ayanian, Nader Rifai; ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, Utah.
In the U.S., the analyzer is classified as moderately complex (CLIA), and some brief user training is required at time of installation. If applied as a stand-alone unit, it comes equipped with an RS-232 port for data communications. Giles says, “Operating the analyzer is simple and intuitive, essentially a matter of collecting the sample in a standard hematology blood tube (EDTA) and pushing a button.”
Alternatively, he explains that the analyzer may be used in combination with any ABX hematology analyzer, accomplished via the company’s HemaLink multi-analyzer data management system, which consolidates instrument data from multiple analyzers. The data manager permits unlimited result storage and also enables a central laboratory to monitor the QC and information logs of remotely located analyzers.
The Paros CRP is a single parameter analyzer. However, says Giles, “If more comprehensive testing is required, it can be used in conjunction with a five-part differential analyzer (ABX’s Pentra 60, for example). Both instruments would use a sample from the same tube, and the combined results would facilitate assessing the cellular markers of inflammation at the same site.”
The Horiba Group (ABX’s parent company) designed the analyzer in Japan to screen large patient populations for inflammatory disease. “More than 90 percent of diagnostic laboratories in Japan are located in physician’s offices,” recounts Giles, “and the Horiba Group has sold more than 3,000 instruments that employ this methodology.” To his knowledge, this instrument is the only analyzer performing CRP on whole blood.
Giles says the initial U.S. marketing effort for the analyzer will focus on oncology clinics with hematology instrumentation. However, he anticipates much wider interest because globally, many specialized clinics use this CRP methodology, for example, diabetic, pediatric, rheumatology and vascular clinics, intensive care units, and outpatient departments that assess large patient populations.
ABX established costing on the analyzer to allow a break-even point corresponding to a workload of five samples per day for the basic unit. Currently, says Giles, Medicare reimburses $7.15 per test. Information required for billing purposes can be captured by existing laboratory or hospital information systems.
Giles concludes that the greatest advantages of the Paros CRP analyzer focus on “enhanced patient workflow through clinics; confident, rapid decision-making in the presence of compromised immunity; and ‘peace of mind’ for patients and clinicians in under five minutes.”
For more information, contact Dr. Ian Giles, Manager, Scientific Affairs, ABX Diagnostics, 34 Bunsen Drive, Irvine, CA 92618. Email: [email protected] Tel: 888-903-5001, ext. 272.
The Paros CRP analyzer is curently pending 510(k) approval.
Gary Wolfe is a freelance writer in Franklin, Massachusetts.
