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 from Abbott.
ALINITY i B·R·A·H·M·S PCT is CE marked and FDA 510(k) cleared.
ALINITY i B·R·A·H·M·S PCT assay can be distinguished by these characteristics:
Limit of quantitation (LoQ) and limit of detection (LoD) values are rounded to two decimal places in alignment with the reported results for the assay.
Correlation between ALINITY i B·R·A·H·M·S PCT and Thermo ScientificTM B·R·A·H·M·S PCTTM sensitive KRYPTORTM.
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.
*Includes within-run, between-run, and between-day variability.
Thermo Fisher Scientific products are distributed worldwide; not all intended uses and applications are registered in every country. Availability of product in each country depends on local regulatory marketing authorization status.