N-端脑利钠肽前体/可溶性生长刺激表达基因2蛋白联合检测试剂盒的临床性能评价

The Evaluation of Clinical Performance of N-Terminal Pro-Brain Natriuretic Peptide Combined with Soluble Growth Stimulating Gene 2 Protein Detection Kit

目的评价N-端脑利钠肽前体(NT-proBNP)/可溶性生长刺激表达基因2蛋白(ST2)联合检测试剂盒的临床性能。方法选取广西中医药大学第一附属医院2023年4—9月收治的130例患者的血清样本,采用巴迪泰(广西)生物科技有限公司生产的NT-proBNP/ST2联合检测试剂盒检测样本的NT-proBNP和ST2水平,分别与罗氏NT-proBNP检测试剂盒、CriticalDiagnostics PresageST2检测试剂盒的检测结果进行相关性和一致性比较(相关性比较采用线性回归分析法,一致性比较采用Bland-Altman Plot分析法)。结果线性回归分析结果显示,联合检测试剂盒NT-proBNP检测结果与罗氏NT-proBNP检测试剂盒检测结果的相关系数R=0.9951,ST2检测结果与Critical Diagnostics Presage ST2检测试剂盒检测结果的相关系数R=0.9958;将联合检测试剂盒与单一检测试剂盒检测NT-proBNP、ST2结果的平均值作为横坐标,差值作为纵坐标,绘制Bland-Altman Plot分析图进行一致性分析,结果显示,两项指标分别有95.38%(124/130)、94.62%(123/130)的值位于范围内。结论NT-proBNP/ST2联合检测试剂盒与单一检测试剂盒检测NT-proBNP和ST2的相关性好、一致性高,可满足临床检测要求。

Objective To evaluate the clinical performance of the N-terminal pro-brain natriuretic peptide(NT-proBNP)combined with soluble growth stimulating gene 2 protein(ST2)detection kit.Methods With the seletion of 130 serum samples from patients admitted to the First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine from April to September 2023,the NT-proBNP/ST2 combined detection kit produced by Boditech(Guangxi)Biotechnology Co.,Ltd.was used to detect the NT-proBNP and ST2 levels in samples.The correlation and consistency were compared with the detection results of Roche's NT-proBNP detection kit and Critical Diagnostics Presage'ST2 detection kit,respectively(linear regression analysis was used for correlation,and Bland Altman Plot analysis was used for consistency).Results The results of linear regression analysis showed that the correlation coefficient R between the NT-proBNP detection results of the combined detection kit and the Roche's NT-proBNP detection kit was 0.9951,and the correlation coefficient R between the ST2 detection results and the Critical Diagnosis Pressure ST2 detection kit was 0.9958;The average value of the results for NT-proBNP and ST2 detection by using the combined detection kit and the single detection kit was used as the x-axis, and the difference was used as the y-axis. A Blank Altman Plot analysis chart was drawn for consistency analysis. The results showed that the values of the two indexes were 95.38% (124/130) and 94.62% (123/130) within the range, respectively. Conclusion The correlation and consistency between the NT-proBNP/ST2 combined detection kit and the single detection kit for detecting NT-proBNP and ST2 are good, which can meet clinical detection requirements.