VITROS® B·R·A·H·M·S PCT™ is an immunometric immunoassay for the determination of PCT (Procalcitonin) in human serum or plasma using the VITROS Systems from Ortho Clinical Diagnostics
VITROS B·R·A·H·M·S PCT is CE marked and FDA 510(k) cleared.
VITROS 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 VITROS B·R·A·H·M·S PCT and Thermo Scientific™ B·R·A·H·M·S PCT™ sensitive KRYPTOR™.
Precision was evaluated consistent with CLSI document EP05. Two replicates each of seven patient pools and three controls were tested on two separate occasions per day on at least 20 different test days. The experiment was performed using three reagent lots on one VITROS ECi/ECiQ Immunodiagnostic System, one VITROS 3600 Immunodiagnostic System, and one VITROS 5600 Integrated System.
* Within-run (repeatability). Between Duplicate precision averaged over all runs.
** Within-lab. A measure of the effect of recalibration on total precision, calculated within reagent lot, using data from at least 4 calibrations.
*** Performance characteristics for the VITROS 5600 System are applicable to the VITROS XT 7600 System.
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.