三种方法检测C-反应蛋白的比对分析

Comparative Analysis of Three Methods for the Detection of C-reactive Protein

目的探讨不同方法检测C-反应蛋白(CRP)结果并进行比对分析。方法采用22份EDTA抗凝全血及血清标本进行3种方法比对,日立7600生化分析仪测定血清CRP作为参考方法,艾科美分析仪和申瑞FIA分析仪测定全血CRP作为实验方法,3种方法分别由不同操作者独立完成检测,进行多仪器(方法)比对;以Bio-systemsCRP校准品加入基础全血(CRP浓度为1.16mg/L)标本中进行回收试验,以观察申瑞FIA、艾科美两种POCT方法正确度,并依此估算线性范围上限;取CRP低值(7.98mg/L)、中值(49.95mg/L)、高值(87.79mg/L)全血标本对FIA、艾科美测定CRP进行简易精密度试验。结果在检测范围0.6-187.43mg/L内(允许总误差以<4mg/L或<20%表示),全部数据均在范围内,一致性良好;使用CRP校准物质BCR470,对申瑞FIA及艾科美全血CRP进行加标回收试验,平均回收率分别为90.9%和105.1%;经估算线性范围上限申瑞F1A、艾科美均为180mg/L左右;简易精密度试验结果显示批内CV分别为9.8%、5.5%,12.2%、6.3%和9.4%、7.1%,重复性符合要求(<15%)。结论申瑞FIA分析仪、艾科美分析仪测定全血CRP整体性能良好。申瑞FIA测定全血CRP数据与血清CRP分析结果更为符合,而艾科美结果稍高一些。检测方法不同结果会有所差异,同一实验室使用不同方法时需注意。

Objective To explore different methods for the detection of C-reactive protein (CRP) and to compare and analyze the results. Methods 22 EDTA anticoagulated whole blood and serum samples were compared by three methods. The determination of serum CRP by Hitachi 7600 biochemical analyzer was used as a reference method, and the whole blood CRP was determined by means of i-Chroma analyzer and SR-FIA analyzer as experimental methods. The Bio-systems CRP calibrator was added to the basic whole blood (CRP concentration 1.16 mg/L) sample for the recovery test to observe the accuracy of the two POCT methods of SR-FIA and i-Chroma and to estimate the upper limit of the linear range. Simple precision test for determination of CRP by FIA and i-Chroma was carried out on whole blood samples with low (7.98 mg/L), median (49.95 mg/L) and high (87.79 mg/L) CRP values. Results Within the detection range 0.6-187.43 mg/L (the total error is allowed to be expressed as < 4 mg/L or < 20%), all data were in range with good consistency. The CRP calibration material BCR470 was used to carry out the standard recovery test on SR-FIA and i-Chroma whole blood CRP. The average recovery rate was 90.9% and 105.1%, respectively, and the estimated upper limit of linear range was about 180 mg/L for SR-FIA and i-Chroma. The results of simple precision test showed that the CV in the assay was 9.8% and 5.5%,12.2% and 6.3%, 9.4% and 7.1% respectively. The repeatability met requirements (< 15%). Conclusion SRFIA analyzer and i-Chroma analyzer has good overall performance in the determination of whole blood CRP. The whole blood CRP data of SR-FIA are more consistent with the serum CRP analysis results, while the results of i-Chroma are slightly highe匚 The results of different detection methods will be different, and attention should be paid to different methods in the same laboratory.