Performance evaluation of Vidas 3 high Sensitive cardiac troponin I measurement procedure

Evaluation of high-sensitivity cardiac troponin measurement procedure performance in serum: the vidas 3 high sensitivity cardiac troponin I T he definition of myocardial infarction (MI) was first made based on electrocardiography by the World Health Organization working groups [1].With the introduction of more sensitive heart biomarkers, MI is redefined by The European Society of Cardiology (ESC) and the American College of Cardiology (ACC) using a biochemical and clinical approach [2].It is reported that myocardial injury detected by abnormal biomarkers in the setting of acute myocardial ischemia should be named as MI.High sensitivity cardiac troponin (hs-cTn) tests provide an early diagnosis in patients with suspected acute coronary syndrome [3].The ESC guideline recommends the 0/3 or 0/1 hour hs-cTn protocol in patients with suspected non-ST segment elevation myocardial infarction (NSTEMI) [4].Current generations of troponin assays have analytical sensitivities up to 100 times greater than the previous generation of troponin assays (1 ng/L vs. 100 ng/L) [5].Therefore, the difference between consecutive levels of hs-cTn (even if bothObjectives: International recommendations suggest that when laboratories begin to use a new measurement procedure, the analytical performance of the new procedure should be evaluated.In this study, we evaluated the analytical performance of the Vidas 3 high sensitivity cardiac troponin I assay.Methods: The precision, linearity, and measurement procedure comparison study were performed according to international standardized protocols (EP15-A3, EP06-A and EP09c).Serum samples were analyzed 20 times and at a frequency of three runs/day on five consecutive days for the calculation the CV% of repeatability and within-laboratory precision.The highest concentration hs-cTnI calibrator was diluted for the preparation of five pools with a concentration range of 9.6-16450 ng/L.The Beckman Dxl 800 analyzer was chosen as the comparative measurement procedure.Results: For low-and high-level concentrations, CV% of repeatability was calculated as 3.12 and 4.74; CV% of within-laboratory precision was calculated as 3.04 and 2.07, respectively.The linear regression analysis showed a line with a good correlation coefficient (r>0.99) over the entire range tested.PassingBablok regression was described with the equation y=0.2995+1.006x.There was no significant deviation from linearity (p=0.800).The 95% confidence interval of the intercept value and slope value was calculated as -1.3734 to 1.0214 and 0.9973 to 1.022, respectively.The mean absolute difference was -12.1ng/L (95% CI=-24.2479 to 0.0979).Conclusion: Vidas 3 hs-cTnI measurement procedure is a precise and linear method for the determination of hs-cTnI.There is no significant difference between Vidas 3 and the Beckman Dxl 800 measurement procedure.