干化学法和湿化学法对24h 尿蛋白定量检测的比较及样本保存条件研究

目的 比较罗氏Cobas 501和天津果实Hipee M1生化分析仪24h尿蛋白定量检测结果的一致性,探讨样本保存条件对检测结果的影响。方法 使用Cobas 501和Hipee M1两台生化分析仪分别对119例尿液常规标本进行24h尿蛋白定量检测,比较检测结果的相关性和一致性。通过混合尿液样本进行不同保存环境以及添加不同防腐剂测试,研究24h尿蛋白样本保存方法对测试结果的影响。结果 两台生化分析仪的质控检测结果的变异系数分别为2.31%～5.61%和3.25%～5.22%,具有很好的重复性。两台生化分析仪尿液样本检测结果经回归分析,检测结果的一致性符合要求,差异无统计学意义(r=0.991,P>0.05)。尿液样本(2～8)℃冷藏保存、使用防腐剂二甲苯和硼酸在常温条件下保存,24h尿蛋白在各个时间点的检测结果,差异均无统计学意义(P>0.05)。结论 Cobas 501和Hipee M1两台仪器之间无明显差异,均具有较高的稳定性,使用硼酸作为防腐剂可用于尿液样本的常温保存。

Comparative Analysis of Dry Chemical Method and Wet-Chemical Methods for the Quantitative Determination of 24-Hour Urinary Protein and Study on the Conditions of Sample Preservation

Objective To compare the stability and consistency of Roche Cobas 501 and Tianjin FRUITECH Hipee M1 biochemical analyzers. Methods 119 cases of urine specimens were detected on Cobas 501 and Hipee M1 biochemical analyzers in parallel and compared the correlation and consistency of the test results. The effects of preservation methods of 24h urine protein samples on the test results were studied by mixing urine samples for different preservation environments and adding different preservative tests. Results The coefficients of variation of the quality control test results of the two biochemical analyzers were 2.31%～5.61% and 3.25%～5.22%, respectively, with good repeatability. The results of urine test of two biochemical analyzers were analyzed by regression analysis, indicating that there was a significant correlation between the two biochemical analyzers, the difference was not statistically significant(r= 0.991, P>0.05). It showed that there was a significant correlation and no significant difference between the results of two biochemical analyzers, and there was no significant difference between them. The difference was not statistically significant. Urine samples were stored at(2～8)℃, preservatives xylene and boric acid were stored at room temperature, and the results of 24h urine protein at various time points were not statistically significant(all P>0.05). Conclusion There was no significant difference between Cobas 501 and Hippe M1 and both of which had high stability. Boric acid can be used as a preservative for the preservation of urine samples at room temperature.