Ziv-Baran Tomer, Shenhar-Tsarfaty Shani, Etz-Hadar Inbal, Goldiner Ilana, Gottreich Ahuva, Alcalay Yifat, Zeltser David, Shapira Itzhak, Angel Yoel, Friedensohn Limor, Ehrenwald Michal, Berliner Shlomo, Rogowski Ori
Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Department of Internal Medicine "C", "D" and "E", Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Clin Chim Acta. 2017 Aug;471:185-190. doi: 10.1016/j.cca.2017.06.008. Epub 2017 Jun 9.
High sensitivity C-reactive protein (hsCRP) has become a routine assessment tool to discriminate between patients at low, intermediate or high risk for cardiovascular events using the threshold values of 1 and 3mg/L, respectively. Over the past years, several studies have proposed the wide range C-reactive protein (wrCRP) as an alternative to the hsCRP in various clinical scenarios. However, the potential use of wrCRP in assessing the cardiovascular risk has not yet been evaluated.
Both wrCRP and hsCRP were evaluated in 15,780 apparently healthy individuals who underwent a routine annual checkup in the Tel Aviv Sourasky Medical Center. Individuals with CRP levels >5mg/L were excluded. Agreement between the two methods was observed using the Bland-Altman method and the concordance correlation coefficient. Deming regression was used to build a calibration equation. Reclassification of individuals' risk level was observed and Cohen's kappa was used to evaluate risk agreement.
A high correlation (r=0.98) along with a significant difference (p<0.001) between hsCRP and wrCRP raised the need for calibration. A simple calibration equation (Adjusted wrCRP=0.3136+0.8803×wrCRP) led to high agreement which enabled 8.4% reclassification of the risk group. A change in the intermediate risk threshold value from 1 to 0.9mg/L led to an almost perfect agreement (kappa=0.87, p<0.001) and a low reclassification rate (7.6%), with under 0.05% of the population undergoing a major reclassification (from high to low risk or vice versa).
In the era of limited financial resources, wrCRP assay may be used as a reasonable routine assay to evaluate the cardiovascular risk in patients undergoing a routine annual checkup.
高敏C反应蛋白（hsCRP）已成为一种常规评估工具，分别使用1mg/L和3mg/L的阈值来区分心血管事件低、中、高风险患者。在过去几年中，多项研究提出在各种临床情况下，宽泛范围C反应蛋白（wrCRP）可作为hsCRP的替代指标。然而，wrCRP在评估心血管风险方面的潜在用途尚未得到评估。
在特拉维夫索拉斯基医疗中心接受年度常规体检的15780名表面健康个体中对wrCRP和hsCRP进行了评估。排除CRP水平>5mg/L的个体。使用Bland-Altman方法和一致性相关系数观察两种方法之间的一致性。采用Deming回归建立校准方程。观察个体风险水平的重新分类，并使用Cohen's kappa评估风险一致性。
hsCRP与wrCRP之间具有高度相关性（r = 0.98）以及显著差异（p<0.001），这表明需要进行校准。一个简单的校准方程（调整后的wrCRP = 0.3136 + 0.8803×wrCRP）导致了高度一致性，使得8.4%的风险组能够重新分类。将中间风险阈值从1mg/L更改为0.9mg/L导致了几乎完美的一致性（kappa = 0.87，p<0.001）和低重新分类率（7.6%），不到0.05%的人群经历了重大重新分类（从高风险到低风险或反之亦然）。
在财政资源有限的时代，wrCRP检测可作为评估接受年度常规体检患者心血管风险的合理常规检测方法。
