Comparison and evaluation of the Elecsys®/cobas™ high sensitivity troponin assay and the Elecsys®/cobas™ troponin assay
Cardiff Metropolitan University
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Aims: The burden of cardiovascular disease in modern healthcare is a problem worldwide, and currently the best approach to solving this problem and reducing mortality rates appears to be rapid diagnosis and the prompt administration of treatment. This study compares and evaluates the analytical performance of the Elecsys®/cobas™ Troponin T High Sensitivity (cTnT hs Assay) Assay and the Elecsys®/cobas™ Troponin T (cTnT Assay) Assay. This study will also investigate the manufacturers claim that the cTnT hs Assay is able to detect and quantify cardiac TroponinT (cTnT) at previously undetectable levels, allowing the earlier diagnosis of acute coronary syndromes (ACS). Methods: For the comparison study serum samples were collected from 160 randomly selected patients and assayed using cTnT and cTnT hs. To determine the analytical performance for both assays patient serum samples were pooled and quality assurance materials were also obtained and analysed using the cTnT and cTnT hs Assays. To identify the diagnostic usefulness of the cTnT hs Assay patient Samples were collected according to the Hywel Dda NHS Trust Policy for requesting cTnT and assayed using the cTnT and cTnT hs Assays. Results: Comparison study results demonstrated a strong positive correlation (R2 = 0.775) between the cTnT and cTnT hs Assay indicating the two assays approximate well, however the cTnT hs Assay was able to obtain statistically relevant values for 62 samples that were not obtained by the cTnT Assay, suggesting that the cTnT hs Assay is the more sensitive of the two assays. Both assays performed well analytically, however cTnT hs Assay did yield results with greater precision (CV, 3% and was also able to detect degrading cTnT more accurately (5% cTnT decrease over 10days) than that of the cTnT Assay. Both assays achieved levels of accuracy acceptable to NEQAS method mean requirements. Notably SD and SEM values were significantly decreased for the EQA samples with method means (cTnT, <0.0740ng/mL, and cTnT hs <0.0980ng/mL) in comparison to those with higher method means. Clinical performance study results demonstrated that the use of cTnT hs would have resulted in the earlier diagnosis of ACS in 8 of the patient admission samples. Additionally 10 pairs of patient samples that were negative both on admission and 12hrs following admission when analysed with the cTnT Assay, were positive when analysed with the cTnT hs Assay, allowing for a risk stratification analysis to be carried out to determine the risk of future cardiac events occurring in such patients. Conclusion: In this small, single-centre study, the TnT hss Assay was found to be superior to the cTnT Assay, particularly with regard to its increased sensitivity thus allowing the earlier detection of myocardial damage in patients admitted to Accident and Emergency Departments.
BSc (Hons) Applied Biomedical Science
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