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

Instrument Architect BRAHMS PCT

Calibrated to the reference standard B·R·A·H·M·S PCT sensitive KRYPTOR.
ARCHITECT B·R·A·H·M·S PCT can be used with the same clinical cut-offs and algorithms.

ARCHITECT 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 ARCHITECT analyzer (Abbott).

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

Assay characteristics

ARCHITECT B·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
Test duration	22 min
Measuring range	0.02-100 μg/L
Limit of Quantification (LoQ)	0.01 μg/L
Analytical sensitivity (LoD)	0.00 μg/L
Limit of Quantitation (LoQ) and Limit of Detection (LoD) values are rounded to 2 decimal places in alignment with the reported results for the assay.

Precision

A study was performed based on guidance from CLSI EP05-A3. Testing was conducted using

2 lots of ARCHITECT B∙R∙A∙H∙M∙S PCT Reagents,
2 lots of ARCHITECT B∙R∙A∙H∙M∙S PCT Calibrators, and
1 lot of ARCHITECT B∙R∙A∙H∙M∙S PCT Controls

on 2 instruments. 3 controls and 3 human plasma panels were assayed in a minimum of 2 replicates at 2 separate times per day on 20 different days.