即时检测全血与传统血浆/血清检测在D-二聚体、降钙素原和N端脑利钠肽前体中的相关性与一致性分析  

Analysis of the correlation and consistency between POCT whole blood and conventional plasma/serum testing for DDI,PCT and NT-proBNP

作　　者：杨萌 梁琼云 凌永基 莫银娟[1] 朱志强 吕艳丽 张懿 丁细霞 郭勇晖[1] YANG Meng;LIANG Qiongyun;LING Yongji;MO Yinjuan;ZHU Zhiqiang;LV Yanli;ZHANG Yi;DING Xixia;GUO Yonghui(Department of Laboratory Medicine,Zhujiang Hos-pital of Southern Medical University,Guangzhou 510000,Guangdong,China;不详)

机构地区：[1]南方医科大学珠江医院检验医学部,广东广州510000 [2]广东省医学检验临床医学研究中心,广东广州510000

出　　处：《实用医学杂志》2025年第8期1232-1237,共6页The Journal of Practical Medicine

基　　金：广东省基础与应用基础研究基金项目(编号:2023A1515220071)。

摘　　要：目的本研究旨在评估即时检测(POCT)技术在全血样本检测D-二聚体(D-dimer,DDI)、降钙素原(procalcitonin,PCT)和N端脑利钠肽前体(N-terminal pro B-type natriuretic peptide,NT-proBNP)中的准确性和一致性,并验证其在临床快速诊断中的可行性。方法分析2022年7—8月期间收集的DDI全血和血浆样本各104例、PCT全血和血清样本各496例、NT-proBNP全血和血清样本各77例。通过MannWhitney U检验、回归分析、相对灵敏度、相对特异度、约登指数和Kappa值评估全血与血浆/血清样本测试结果的一致性及准确性。结果DDI、PCT和NT-proBNP的全血与血浆/血清样本检测结果显示良好一致性,相关系数分别为r^(2)=0.9512、r^(2)=0.9428和r^(2)=0.9916(P>0.05)。在医学决定水平下,DDI(0.55μg/mL)相对灵敏度为94.3%,相对特异度为94.1%,约登指数为0.88,Kappa值为0.87;PCT(0.5 ng/mL和2.0 ng/mL)的相对灵敏度分别为均97.4%、89.0%,相对特异度分别为95.8%、98.3%,约登指数分别为0.93、0.87,Kappa值分別为0.93和0.89;NT-proBNP(125 pg/mL)的相对灵敏度为94.1%,相对特异度100%,约登指数0.94,Kappa值为0.87。这些结果表明全血标本检测的高度准确性及两种方法结果的高度一致性。结论该研究验证了POCT技术在全血样本检测DDI、PCT和NT-proBNP的有效性,结果显示其与传统血浆/血清方法具有高度一致性,支持POCT在快速诊断中的临床应用价值。Objective To assess the accuracy and consistency of point-of-care testing(POCT)technology in detecting D-dimer(DDI),Procalcitonin(PCT),and N-terminal pro B-type natriuretic peptide(NT-proBNP)in whole blood samples,as well as to validate its feasibility for rapid clinical diagnosis.Methods From July 8 to August 22,2022,a total of 104 paired DDI whole blood and plasma samples,496 paired PCT whole blood and serum samples,and 77 paired NT-proBNP whole blood and serum samples were collected.The consistency and accuracy of test results between whole blood and plasma/serum samples were assessed using the Mann-Whitney U test,regression analysis,relative sensitivity,relative specificity,Youden′s index,and Kappa value.Results The test results of DDI,PCT,and NT-proBNP in whole blood and plasma/serum samples demonstrated excellent consistency,with correlation coefficients of r^(2)=0.9512,r^(2)=0.9428,and r^(2)=0.9916,respectively,and all P-values exceeding 0.05.At the medical decision levels,for DDI(0.55µg/mL),the relative sensitivity,rela-tive specificity,Youden index,and Kappa value were 94.3%,94.1%,0.88,and 0.87,respectively.For PCT(0.5 ng/mL and 2.0 ng/mL),the relative sensitivities were 97.4%and 89.0%,the relative specificities were 95.8%and 98.3%,the Youden indices were 0.93 and 0.87,and the Kappa values were 0.93 and 0.89,respectively.For NT-proBNP(125 pg/mL),the relative sensitivity was 94.1%,the relative specificity was 100%,the Youden index was 0.94,and the Kappa value was 0.87.These findings confirm the high accuracy of whole blood sample testing and the strong concordance between the two methods.Conclusions This study confirmed the efficacy of POCT technology for detecting DDI,PCT,and NT-proBNP in whole blood samples.The results showed a high level of consistency compared to traditional plasma/serum methods,thereby reinforcing the clinical applicability of POCT for rapid diagnosis.

关 键 词：即时检测 D-二聚体 降钙素原 N端脑利钠肽前体 全血样本 血浆/血清样本 

分 类 号：R446.112[医药卫生—诊断学]