engleski

Evaluation of RAMP Troponin I Point of Care Assay

Rapid troponin testing has become a prerequisite for adequate and timely management of chest pain patients. In that respect, quantitative point of care testing (POCT) devices, if reliable, would offer the benefit of greatly reduced turnaround time (TAT) as compared with centralized testing. Thus, we performed short analytical evaluation of the TnI method on RAMP POCT device (Rapid Analysis Measurement Platform, RAMP Corp, Burnaby, Canada). It is a fluorescence immunochromatography quantitative method that utilizes diluted whole blood. Results are available after 19 minutes. The analytical sensitivity of the system is shown to be 0.16 ng/ml, which makes it inadequate for risk stratification purposes. Reproducibility at 1.18 ng/ml was 7.3%, which is satisfactory and comparable to laboratory methods. The patients' results were compared with Dimension RxL (Dade Behring, Deerfield, IL) fully automated EIA method (N = 50). The correlation coefficient for the whole patient series was acceptable (0.977) ; however, it became much less favorable (0.682) when values above 6 ng/ml were excluded. Linear regression equation (y = 0.2871x + 0.0986) pointed out the consistently lower values obtained by RAMP method. The bias was on the average three-fold and thus statistically significant. This raises particular concern for the patients in the early stages of AMI with minor troponin elevations. Although obtained on a small patient series, our results point out that RAMP AMI cut-off should be chosen carefully to avoid false negatives. The 0.3 ng/ml cut-off suggested by the manufacturer may still be too high.

troponin; point-of-care; turn-around-time

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