The ability of the wide range CRP assay to classify individuals with low grade inflammation into cardiovascular risk groups. of sample results concordant by both methods for the risk stratification Lacidipine was 96.0% ((temperature 19.0??0.4C). 2.2. Assay procedures C\reactive protein values were analyzed by wr\CRP and hr\CRP methods on a Cobas c702 analyzer (Roche Diagnostics), using the latex\enhanced immunoturbidimetric assay (wr\CRP: C\Reactive Protein Gen. 3 reagent kit, ref#05172373190, turbidity measurement at 546?nm; hr\CRP: Cardiac C\Reactive Protein Latex High Sensitive reagent kit, ref#05950864190, turbidity measurement at 570?nm). The analytic measurement range of wr\CRP and hr\CRP was 0.3\350 and 0.15\20?mg/L, respectively. Both methods were calibrated and internal quality Lacidipine controls (IQC) were established before the determination, and accuracy was verified with satisfactory results of the external quality assessment programs organized by the National Center for Clinical Laboratories of China (NCCL). Roche hs\CRP assay was taken as the comparison method based on previous analytical and clinical validations.12, 13 2.3. Statistical analysis Method comparison and bias estimation were performed referring to Clinical & Laboratory Standards Institute (CLSI) EP09C document.14 Because the distribution of CRP results was skewed rightward, median concentrations were computed and method differences were assessed by the Wilcoxon signed rank test. Deming regression was used to evaluate the slope, intercept, and value 0.05 was considered to be statistically significant. IBM SPSS Statistics for Windows, version 24 (IBM Corp.), and EP evaluator release 12.0 (Data Innovations LLC) were used for statistical analysis. 3.?RESULTS We enrolled 200 participants with CRP level of 20?mg/L assayed with either wr\CRP or hs\CRP method in the study. The mean??SD age of participants was 46.3??6.7?years (84 women and 116 men, respective mean??SD age being 46.7??6.4 and 46.1??7.0?years). Between\run precision (six consecutive months) showed coefficients of variation in the range of 2.78%\4.24% and 2.72%\4.51% for the wr\CRP and hs\CRP methods, respectively. The median of CRP results by wr\CRP method (2.800?mg/L) was significantly higher than that of hs\CRP method (2.680?mg/L; valuevalue /th /thead Total group2000.995 em P /em ? ?0.0001 em y /em ?=?0.008?+?1.058 em x /em 1.058 (1.036\1.0790.008 (?0.020 to ?0.036)0.9292 em P /em ? ?0.0001SubgroupLow\risk (hs\CRP? ?1?mg/L)490.930 em P /em ? ?0.0001 em y /em ?=??0.029?+?1.111 em x /em 1.111 (0.990\1.232)0.029 (?0.099 to 0.040)0.9292 em P /em ? ?0.0001Moderate\risk (1??hs\CRP??3?mg/L)550.928 em P /em ? ?0.0001 em y /em ?=??0.148?+?0.985 em x /em 0.985 (0.897\1.073)0.148 (?0.018 to 0.315)0.9484 em P /em ? ?0.0001High\risk (hs\CRP? ?3?mg/L)960.983 em P /em ? ?0.0001 em y /em ?=??0.518?+?1.146 em x /em 1.146 (1.046\1.246)?0.518 (?0.990 to 0.047)0.9543 em P /em ? ?0.0001 Open in a separate window NoteDeming regression was used to evaluate the slope, intercept, and em r /em . 95% Lacidipine CI95% confidence interval. Spearman’s rhoSpearman’s coefficient of rank correlation. aCRP results were not normally distributed, and Spearman’s rank correlation analysis was used to assess correlations between both methods for the total, low\risk, moderate\risk, and high\risk SLI groups. Deming regression analysis gave a Lacidipine slope of 1 1.058 (95% CI: 1.036\1.079) with an intercept of 0.008 (95% CI: ?0.020 Lacidipine to 0.036) for the total group (Figure ?(Figure1),1), a slope of 1 1.111 (95% CI: 0.990\1.232) with an intercept of 0.029 (95% CI: ?0.099 to 0.040) for low\risk group, a slope of 0.985 (95% CI: 0.897\1.073) with an intercept of 0.148 (95% CI: ?0.018 to 0.315) for moderate\risk group, and a slope of 1 1.146 (95% CI: 1.046\1.246) with an intercept of ?0.518 (95% CI: ?0.990 to 0.047) for high\risk group. The detailed Deming regression results are shown in Table ?Table11. Open in a separate window Figure 1 Deming regression of CRP results between wr\CRP and hs\CRP methods. The dashed range represents the family member type of identification, whereas the solid range represents the Deming regression range. Slope?=?1.058 (95% CI: 1.036\1.079); intercept?=?0.008 (95% CI: ?0.020 to 0.036); em r /em ?=?0.9292; n?=?200 3.2. Technique assessment and bias evaluation Rated purchase difference plots and rated purchase percent difference plots between both strategies were drawn discussing the CLSI EP09C process. The variations exhibited a continuing coefficient of variant. The median technique difference (wr\CRP???hr\CRP) was 0.120?mg/L (95% CI, 0.086\0.200?mg/L; Number ?Number2A),2A), as well as the median percent difference [(wr\CRP???hr\CRP)/hr\CRP??100%] was 7.34% (95% CI, 4.27%\8.47%; Number ?Number2B).2B). Besides, the expected bias was determined using the formula through the Deming regression evaluation. The percent bias between both strategies at the provided cutoff CRP ideals of just one 1, 3, and 10?mg/L evaluated by Deming regression evaluation was 6.60%, 6.07%, and 5.88%, respectively. Furthermore, the percent biases examined by Moving\Bablok regression and.