AI Article Synopsis
- - The study focuses on determining sex-specific 99th percentile upper reference limits (URLs) for cardiac troponin I (cTnI) to improve accuracy in diagnosing acute myocardial infarction (AMI).
- - Blood samples from 300 males and 300 females were analyzed using two different high-sensitivity assays on the UniCel DxI 800 platform, revealing specific URLs of 5.5 ng/L for females and 13.9 ng/L for males for the Access hsTnI assay.
- - The researchers found that the Access hsTnI URLs were lower than the manufacturer's claims due to differences in population selection and sample types, leading them to suggest sticking with the manufacturer's original reference values.
Article Abstract
Background: The detection of an increase and/or decrease of cardiac troponin (cTnI) values, with at least one value above the 99th percentile of the upper reference limit (URL) have a central role in acute myocardial infarction (AMI) diagnosis. The employment of sex specific 99th percentile URLs and High-sensitivity (Hs) assays are recommended. We assessed sex specific 99th percentile URL for Access Hs-cTnI and AccuTnI3+ (Beckman Coulter) using European donor reference population following recent International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) recommendations.
Methods: 300 males and 300 females plasma samples were collected. Both chemiluminescent immunoenzymatic assays were performed on UniCel DxI 800 platform (Beckman Coulter).
Results: For Access hsTnI, the observed sex-specific 99th percentile URLs were 5.5 (90% CI: 4.4-7.6) for females and 13.9 ng/L (90% CI: 7.4-17.4) for males. For AccuTnI+3 we could not establish them because the assay couldn't report detectable values of troponin for most of the analyzed samples.
Conclusion: The sex-specific 99th percentile URLs established for Access hsTnI assay were significantly lower than those declared by the manufacturer caused by the different choice of population selection, age groups and sample types: for those reasons, we maintain the 99th URLs provided by manufacturer.
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| http://dx.doi.org/10.1016/j.cca.2019.01.028 | DOI Listing |
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