Determination of procalcitonin (PCT) in micro-method on AQT90 FLEX® analyzer and in vitro stability study

Abstract

Radiometer® has developed a point-of-care test for fast PCT measurement on whole blood in micromethod on a AQT90 FLEX® instrument. We have verified the analytical performances of the AQT90 FLEX® PCT assay in heparinized macrotube and EDTA microtube for pediatric use, according to modified French Society of Clinical Biology (SFBC) protocol to the requirements of the standard NF EN ISO 15189: 2012. The samples (n=61, 30 macrotubes, 31 microtubes) were analyzed by the Brahms Kryptor Compact Plus® reference method vs the AQT90 FLEX®. In a second step, we studied the stability of the PCT at room temperature for 24 h. A good correlation between the two methods on macro- or microtubes is observed (respectively r=0.990 and 0.993). The Bland-Altmann representations confirm the excellent correlation with a deviant, above the acceptable limit, which was calculated according to ISO 5725-6, for each type of tube and for the two concentration ranges (lower and greater than 1 ng/mL). The biases observed do not affect the clinical decision. No degradation of PCT after 24 h was demonstrated by the Mann and Whitney test on macro- and microtubes (p=0.50 and 0.34, respectively). The determination of PCT on AQT90 FLEX® has satisfactory analytical characteristics and can be used as point-of-care testing device on whole blood without pre-analytical treatment. In heparinized macrotube and EDTA microtube, the PCT is stable at room temperature up to 24 h.