Analytical and Clinical Performance of Two Cardiac Troponin I Immunoassays
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Zahur Zaman
Abstract
Cardiac troponin I assays for Axsym (Abbott Diagnostics, Abbott Park, IL, USA) and Immuno 1 (Bayer Corporation, Tarrytown, NY, USA) analysers were evaluated. Heparin plasma or serum could be used for both assays. Samples were stable for 24 h at ambient temperature, 3 days at 4–8 ℃ and 3 months at −20 °C. After 10 months' storage at −80 °C, the recoveries were well above 100 % by both assays. Total coefficients of variation for Axsym assay were 9.0 %, 5.8 % and 5.3 % at concentrations of 2.6 μg/l, 9.83 μg/l and 34.3 μg/l respectively; for Immuno 1 these were 4.4 %, 1.6 % and 1.8 % at 2.3 μg/l,6.27 μg/l and 44.35 μg/l respectively. It was ≥ 20 % at concentration of ≤ 0.5 μg/l for Axysm assay and ≤ 0.15 μg/l for Immuno 1 assay. Recoveries were ≤ 90 % at ≤ 0.22 μg/l on Axsym and at ≤ 1.47 μg/l on Immuno 1. Neither method showed significant interference with haemoglobin, bilirubin, triglycerides or rheumatoid factor. Correlation between the two methods was excellent (r = 0.997, Y (Axsym) = 4.2X (Immuno 1) + 3.2). The highest concentrations detected in 50 healthy subjects were 0.3 μg/l and 0.1 μg/l by Axsym and Immuno 1 methods, respectively. Twelve out of 43 renal failure patients had troponin I 0.13–0.9 μg/l using Axsym method and 4 had levels of 0.07–0.13 μg/l using Immuno 1. In muscle trauma patients, troponin I was undetectable.
Copyright © 1999 by Walter de Gruyter GmbH & Co. KG
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