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The Analytical Performance Assessment and Clinical Application of High-sensitivity Cardiac Troponin Assays

Author: SongLingYan
Tutor: PanBaiShen
School: Fudan University
Course: Clinical Laboratory Science
Keywords: Cardiac troponin Acute myocardial infarction Diagnostic techniques and procedures Evaluation
CLC: R446.1
Type: Master's thesis
Year: 2011
Downloads: 89
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Background: Cardiac troponin is the preferred marker for the diagnosis of acute myocardial infarction. High diagnostic sensitivity and specificity of cardiac troponin myocardial injury, disease, short-term and long-term prognostic value of non-ST-segment elevation acute myocardial infarction in patients with early intervention therapy provides reliable information troponin assays have been widely clinical application. In fact, patients with suspected acute coronary syndrome (ACS), cardiac troponin has become a routine test items. The latest, however, can be accurately detected in peripheral blood in low concentrations of troponin detection technology, not only to improve the diagnostic accuracy of the ACS, troponin challenge mode appears only in the peripheral blood of patients with myocardial infarction. In addition, different troponin assays revealed troponin levels can be detected in the peripheral blood can occur in different disease conditions, elevated troponin levels associated with poor prognosis. Proposed the cTn clinical judgment value in 2000 and 2007 the AMI to re-define the file should be taken as the 99th percentile value of the upper limit of the reference range of apparently healthy people [at the same time the requirements of this detection precision (CV%) should cTn detection has been replaced by \CTn detection method is constantly updated, with the needs of the clinical applications and the development of science and technology, has ushered in the era of highly sensitive method of detection. This study is divided into three parts, the first part: To evaluate highly sensitive cardiac troponin T (high-sensitivity cardiac troponin T, hs-cTnT) analysis performance, understand its biological variability, the establishment of the laboratory reference range. Methods AMI patients (n = 100) and apparently healthy human serum (474 ??cases), evaluation hs-cTnT functional sensitivity of detection and intra batch imprecision (CV said), and the currently used conventional myocardial muscle calcium protein T (conventional cardiac troponin T, con-cTnT) are compared to detect the concentration of hs-cTnT in the serum of apparently healthy people, the establishment of the laboratory reference range; assess the short-term and long-term biological variation of hs-cTnT. Results functional sensitivity of hs-cTnT 0.005μgL, low concentrations (0.014μgL) intra-and inter-assay CV were 2.97% and 3.64%; high concentration (2.500μgL) Intra-and inter-assay CV were 0.66% and 1.01% . hs-cTnT and con-cTnT test results good correlation (R2 = 0.972, P lt; 0.01). The laboratory hs-cTnT apparently healthy population 99th percentile values ??are: women ≤ 60 years of age to 0.003 μg / L, men aged ≤ 60 0.008μgL female gt; 60 years 0.015μgL, male gt; 60-year-old 0.021μg / L. 22 apparently healthy volunteers of short-term biological variation of hs-cTnT were: CVa = 3.8%, CV1 = 4.8% CVg = 58.5% = 49.9% and CVt; Long-term biological variation were: CVa = 5.3%, CVi = 6.4%, CVg = 56.6% = 68.3% and CVt. Days and days between individual index 11, respectively, 0.18 and 0.23. Part II: Objective To evaluate the clinical value of hs-cTnT in the diagnosis of AMI. Methods 147 cases of confirmed AMI patients (122 cases of NSTEMI patients) admitted to hospital immediately sample hs-cTnT, con-cTnT positive rate. Detected 481 cases of chest pain patients admitted to hospital five different time points (admission 4h immediately after admission, 12h, 20h and 28 h) serum samples hs-of cTnT con-of cTnT CKMBmass and MYO concentrations at different times of patients with confirmed AMI indicators point positive rate. Based on the ROC curve analysis to compare the characteristics of each cardiac markers in the diagnosis of AMI. Compare AMI group dynamic monitoring, non-AMI heart disease group, AMI-related high-risk disease group and the control group of apparently healthy 4h within the the cTnT concentration change rate of hospitalization. Results confirmed AMI and the NSTEMI patients hospitalized immediate hs-cTnT positive rate of 90.3% and 91.0%, respectively, significantly higher than the con-cTnT 61.9% and 60.6% (P lt; 0.01). Admission detection of different indicators at each time point (hs-cTnT, con-cTnT, CKMB mass and MYO), hs-cTnT positive rate of up to 100% (admission after 4h) con-up to 99.2% of cTnT (admission 12h after), CKMB mass of up to 92.1% (admission after 12h), up to 74% MYO (4h after admission). hs-cTnT, con-cTnT, CKMB mass and MYO admission of the immediate area under the ROC curve (AUC) were 0.935,0.851,0.827 and 0.769, hs-cTnT con-of cTnT, CKMB mass and the MYO between AUC difference was statistically significance (Z1 = 3.13 Z2 = 4.46 Z3 = 5.62, P lt; 0.05). The dynamic monitoring AMI group, the rate of change of the other three groups the rate of change of 203.03% (25.00% to 2036.40%), 0.00% (-3.48% to 5.21%), 0.00% (-1.17% to 2.00%) and -1.97% ( -3.83% to 0.007%), the difference was significant (χ2 = 166.09, P lt; 0.01). Part III: To evaluate the analytical performance of the different cTnI detection method, and observed compared clinical applications, to help select the detection method for the laboratory. Methods to collect the surface of the healthy population (474 ??cases) and emergency room patients with chest pain admission (112 cases) serum, the three cTnI assay method was evaluated functional sensitivity (CV = 10%), and to establish the appropriate reference range, according to Apple proposed judgment mode analysis of the kinds of system performance compared to assess the the preliminary clinical value of different detection methods, and laboratory self reference range for validation, the correlation between the different detection methods. Results, Abbott, Beckman - Kurt Johnson detection method CV = 10% and the surface of the healthy population 99th percentile values ??were 0.030μg / L, and 0.021μg / L; 0.04μg / L and 0.02μg / L, and 0.013 μg / L and 0.026μg / L. Chest pain hospitalized patients admitted to hospital immediately sample ROC curve analysis, Abbott, Beckman - Kurt Johnson detection method under the curve (AUC) was 0.852,0.909 and 0.910, respectively, either of the two detection methods compare AUC was not significantly different ( Z1 = 1.18, Z2 = 1.21, Z3 = 0.026, P are gt; 0.05); admission instantly samples AMI diagnostic performance comparison, the use of the laboratory self and manufacturers declare as no significant difference between the judgment value (Abbott, Baker Man - Kurt Johnson Kappa values ??were 1.000,0.730,0.893, P lt; 0.01).

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