ALINITY i B·R·A·H·M·S PCT (License Partner: Abbott)

Alinity-CI

ALINITY i B·R·A·H·M·S PCT is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of PCT (Procalcitonin) in human serum and plasma on the automated ALINITY i analyzer (Abbott).

ALINITY i B·R·A·H·M·S PCT is CE marked and FDA 510(k) cleared.

Assay characteristics

ALINITY iB·R·A·H·M·S PCT assay can be distinguished by these characteristics:

Test principle	CMIA
Sample matrix	Serum, plasma (heparin, EDTA)
Sample volume	150 μL
Time to result	22 min
Measuring range	0.02-100 μg/L
Limit of quantitation (LoQ)	0.01 μg/L
Limit of detection (LoD)	0.01 μg/L

Precision

A study was performed based on guidance from CLSI EP05-A2.

Testing was conducted using 1 lot of the ALINITY i B∙R∙A∙H∙M∙S PCT Reagent Kit, 1 lot of the ALINITY i B∙R∙A∙H∙M∙S PCT Calibrators, and 1 lot of the ALINITY i B∙R∙A∙H∙M∙S PCT Controls and 1 instrument. Three controls and 4 human plasma panels were assayed in a minimum of 2 replicates at 2 separate times per day on 20 different days.