engleski

Verification of claimed limit of detection for the Roche Troponin T hs STAT assay

Detection of cardiac biomarker troponin T (cTnT) together with other evidence of myocardial ischaemia makes important criteria for the diagnosis of myocardial infarction (MI). Limit of detection (LoD) is defined as the lowest amount of analyte in a sample that can be detected by given analytical procedure. Establishment of the limit of detection for cTnT has important role in assessment of patient suspected for MI. The aim of our study was to verify the claimed limit of detection of 0.005 μg/L for the cTnT assay (Roche Troponin T hs (high sensitive) STAT (Short Turn Around Time)) according the Clinical and Laboratory Standards Institute (CLSI) EP17-A protocol. Materials and methods: Verification of the claimed LoD was performed on Cobas e 411 analyzer (Roche Diagnostics GmbH, Mannheim, Germany). Twenty repeated measurements of pooled plasma samples with concentration of cTnT 0.005 μg/L were performed. Results: Claimed LoD for the Roche Troponin T hs STAT assay showed that observed proportion (20/20) is in accordance with the expected value (95%) at concentration of 0.005 μg/L. Conclusions: Our data support the LoD claimed by Roche for Troponin T hs STAT assay.

limit of detection ; verification ; troponin T assay

nije evidentirano