两种自动化高敏C反应蛋白检测方法在大样本人群中的比较研究

Comparative study of two automated high-sensitivity C-reactive protein methods in a large population.

作者信息

Lolekha Porntip H, Chittamma Anchalee, Roberts William L, Sritara Piyamitr, Cheepudomwit Sayan, Suriyawongpaisal Paibul

机构信息

Division of Clinical Chemistry, Department of Pathology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.

出版信息

Clin Biochem. 2005 Jan;38(1):31-5. doi: 10.1016/j.clinbiochem.2004.09.001.

DOI:10.1016/j.clinbiochem.2004.09.001

PMID:15607314

Abstract

OBJECTIVES

Increased serum C-reactive protein (CRP) is associated with future risk of coronary heart disease in apparently healthy individuals. Numerous high-sensitivity CRP (hs-CRP) methods are available but their comparability in large populations has not been assessed. This study aimed to evaluate the performance of two CRP methods in a large Asian population.

DESIGN AND METHODS

We compared the Tina-quant CRP immunoturbidimetric assay (Roche COBAS INTEGRA) to the N high-sensitivity latex-enhanced immunonephelometric (BN 100 nephelometer, Dade Behring) assay using 4118 serum samples from the International Collaborative Study on Atherosclerosis and Stroke in Asia (Inter ASIA).

RESULTS

The median hs-CRP value for the N high-sensitivity CRP method (1.23 mg/L) was significantly lower than that for the Tina-quant method (1.50 mg/L), P < 0.001. The two methods were highly associated (r = 0.9916). Deming regression analysis gave a slope of 0.958 [95% confidence interval (CI): 0.954-0.962] with an intercept of 0.280 [95% confidence interval (CI): 0.268-0.292]. The mean of the method differences was 0.19 mg/L and the limits of agreement (LOA), which encompass 95% of results, were -0.36-0.74 mg/L. We found the percentages of low, average, and high-risk results were 42.9, 33.8, and 23.3 for the N high-sensitivity CRP and 33.2, 41.1, and 25.7 for the Tina-quant method. The percentage of samples concordant by both methods was 87.4%. The Tina-quant CRP classified more subjects into the high-risk group.

CONCLUSIONS

The two hs-CRP methods were highly associated and are suitable for screening large populations.

摘要

目的

血清C反应蛋白（CRP）升高与看似健康个体未来患冠心病的风险相关。有多种高敏CRP（hs-CRP）检测方法，但它们在大量人群中的可比性尚未得到评估。本研究旨在评估两种CRP检测方法在一大亚洲人群中的性能。

设计与方法

我们使用来自亚洲动脉粥样硬化与中风国际合作研究（Inter ASIA）的4118份血清样本，将Tina-quant CRP免疫比浊法（罗氏COBAS INTEGRA）与N高敏乳胶增强免疫比浊法（BN 100比浊仪，德灵）进行比较。

结果

N高敏CRP检测方法的hs-CRP中位数（1.23mg/L）显著低于Tina-quant检测方法（1.50mg/L），P<0.001。两种方法高度相关（r = 0.9916）。Deming回归分析得出斜率为0.958[95%置信区间（CI）：0.954 - 0.962]，截距为0.280[95%置信区间（CI）：0.268 - 0.292]。方法差异的均值为0.19mg/L，包含95%结果的一致性界限（LOA）为 - 0.36 - 0.74mg/L。我们发现N高敏CRP检测方法低、中、高风险结果的百分比分别为42.9%、33.8%和23.3%，Tina-quant检测方法分别为33.2%、41.1%和25.7%。两种方法结果一致的样本百分比为87.4%。Tina-quant CRP检测方法将更多受试者归类为高风险组。