The Access AccuTnI assay demonstrated comparable performance on the UniCel DxI 800 and Access 2 platforms, with 10% CV values of 0.0577 and 0.0486 microg/L, respectively.
Observational (n=679)
Does the Access AccuTnI assay perform comparably on the UniCel DxI 800 and Access 2 platforms?
The Access AccuTnI assay demonstrates reliable and comparable analytical performance for cardiac troponin I across the UniCel DxI 800 and Access 2 platforms.
BACKGROUND: Cardiac troponins currently represent the preferred biomarkers for the detection of myocardial necrosis. The objective of the present study was to compare the performance of the Access AccuTnl assay (Beckman Coulter) measured on two different platforms, the UniCel Dxl 800 and the Access 2 (Beckman Coulter). In particular, the serum cardiac troponin I (cTnl) concentration corresponding to 10% coefficient of variation (CV), the cTnl assay minimum detectable concentration (MDC), and the serum cTnl 99th percentile in healthy subjects were calculated. METHODS: The Access AccuTnl is a paramagnetic particle chemiluminescent immunoassay. Imprecision profiles were determined according to the Clinical and Laboratory Standards Institute EP5-A protocol using serum pools. The MDC was calculated as mean +3 SD of 20 determinations of the zero calibrator during one run. The 99th percentile was determined analyzing serum samples from 679 healthy blood donors (523 males, 156 females; 18-71 years old). RESULTS: cTnl concentrations are given in microg/L. 10% CV values (95% confidence interval, CI) were 0.0577 (0.0467-0.0750) (UniCel Dxl 800) and 0.0486 (0.0255-0.0596) (Access 2). MDC values were 0.011 (UniCel Dxl 800) and 0.012 (Access 2). The 99th percentile (95% CI) value was 0.0340 (0.0298-0.0410). CONCLUSIONS: Our data confirm the reliability of the evaluated cTnl assay and demonstrate the comparability of the cTnl values between the platforms studied.
Zaninotto et al. (Thu,) conducted a observational in Healthy subjects (n=679). Access AccuTnI assay on UniCel DxI 800 vs. Access AccuTnI assay on Access 2 was evaluated on 10% coefficient of variation (CV) concentration, minimum detectable concentration (MDC), and 99th percentile. The Access AccuTnI assay demonstrated comparable performance on the UniCel DxI 800 and Access 2 platforms, with 10% CV values of 0.0577 and 0.0486 microg/L, respectively.
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