ATELLICA® IM B·R·A·H·M·S PCT™ assay is for in vitro diagnostic use in the quantitative determination of procalcitonin (PCT) in human serum and plasma using the Atellica analyzers from Siemens Healthcare Diagnostics.
ATELLICA IM B·R·A·H·M·S PCT is CE marked and FDA 510(k) cleared.
ATELLICA IM 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 ATELLICA® IM B·R·A·H·M·S PCT and Thermo Scientific™ B·R·A·H·M·S PCT sensitive KRYPTOR™.
Precision was determined in accordance with CLSI Document EP05‑A3. Samples were assayed on an ATELLICA IM Analyzer in duplicate in 2 runs per day for 20 days. The assay was designed to have within-laboratory precision of ≤25% coefficient of variation for samples from 0.05–0.10 µg/L, and ≤15% CV for samples >0.10 µg/L.
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.