C-Reactive Protein infection test Piccolo, says Abaxis

Piccolo Xpress, a test to detect infection and inflammation by Abraxis, has been approved by US FDA.

Piccolo Xpress is a C-Reactive Protein (CRP) assay when used by healthcare professionals in conjunction with the Piccolo Xpress point-of-care analyzer, Abraxis announced.

U.S. healthcare professionals can now conduct on-site chemistry analysis in less than 12 minutes for many types of conditions including infections, inflammatory diseases, tissue injury and some neoplastic processes, as a result of this new FDA 510K approval.

C-Reactive Protein is widely used as an indicator of inflammation or infection and will initially be made available to the U.S. market on an acute care panel called MetLyte Plus CRP.

The most common use of the C-Reactive Protein assay is by rheumatologists in the detection and treatment of rheumatoid arthritis, although the test has utility in the detection and treatment of other afflictions including colon cancer, non Hodgkin’s lymphoma, fever from bacterial infections, atrial fibrillation and osteomyelitis.

Abaxis is also investigating other configurations of tests along with C-Reactive Protein that may have additional utility to Physicians at the point-of-care.

“With the addition of the C-Reactive Protein assay, Abaxis continues to add valuable specialty tests to its already broad general chemistry menu offering,” said Clint Severson, chairman and chief executive officer of Abaxis, Inc.

The C-Reactive Protein assay has been in use outside the United States, in Europe and Asia Pacific for over 6 months. In these regions, CRP is widely used as a standard test in general health screenings, and as part of routine clinical practice. Usage of the test continues to grow as Physicians learn about its availability and ease of use at the point-of-care.

Abaxis develops, manufactures and markets portable blood analysis systems for use in any veterinary or human patient-care setting to provide clinicians with rapid blood constituent measurements. The system consists of a compact, 5.1 kilogram (11.2 pounds), portable analyzer and a series of single-use plastic discs, called reagent discs that contain all the chemicals required to perform a panel of up to 14 tests on veterinary patients and 26 tests on human patients.

The system can be operated with minimal training and performs multiple routine tests on whole blood, serum or plasma samples. The system provides test results in less than 12 minutes with the precision and accuracy equivalent to a clinical laboratory analyzer.