医学检查与临床诊断

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

  • 杨萌 ,
  • 梁琼云 ,
  • 凌永基 ,
  • 莫银娟 ,
  • 朱志强 ,
  • 吕艳丽 ,
  • 张懿 ,
  • 丁细霞 ,
  • 郭勇晖
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  • 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 )

收稿日期: 2024-12-20

  网络出版日期: 2025-04-30

基金资助

广东省基础与应用基础研究基金项目(2023A1515220071)

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

  • Meng YANG ,
  • Qiongyun LIANG ,
  • Yongji LING ,
  • Yinjuan MO ,
  • Zhiqiang ZHU ,
  • Yanli LV ,
  • Yi ZHANG ,
  • Xixia DING ,
  • Yonghui. GUO
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  • Department of Laboratory Medicine,Zhujiang Hospital of Southern Medical University,Guangzhou 510000,Guangdong,China

Received date: 2024-12-20

  Online published: 2025-04-30

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Mann-Whitney 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r2 = 0.951 2、r2 = 0.942 8和r2 = 0.991 6(P > 0.05)。在医学决定水平下,DDI(0.55 μg/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。

本文引用格式

杨萌 , 梁琼云 , 凌永基 , 莫银娟 , 朱志强 , 吕艳丽 , 张懿 , 丁细霞 , 郭勇晖 . 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[J]. 实用医学杂志, 2025 , 41(8) : 1232 -1237 . DOI: 10.3969/j.issn.1006-5725.2025.08.021

Abstract

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 r2 = 0.951 2, r2 = 0.942 8, and r2 = 0.991 6, respectively, and all P-values exceeding 0.05. At the medical decision levels, for DDI (0.55 μg/mL), the relative sensitivity, relative 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.

参考文献

1 ZHAO D, LIU J, WANG M, et al. Epidemiology of cardiovascular disease in China: Current features and implications [J]. Nat Rev Cardiol, 2019, 16(4): 203-212. doi:10.1038/s41569-018-0119-4
2 国家急诊医学专业医疗质量控制中心, 北京市急诊质量控制和改进中心, 中国医师协会急诊医师分会, 等. 即时检测急诊临床应用专家共识 [J] .中华急诊医学杂志,2024, 33(1): 11-19.
3 YE Q, LU D, ZHANG T, et al. Recent advances and clinical application in point-of-care testing of SARS-CoV-2 [J]. J Med Virol, 2022, 94(5): 1866-1875. doi:10.1002/jmv.27617
4 SHIRLEY J D, BENNETT S A, BINNICKER M J. Current regulatory landscape for viral point-of-care testing in the United States [J]. J Clin Virol, 2023, 164: 105492. doi:10.1016/j.jcv.2023.105492
5 降钙素原在成人下呼吸道感染性疾病分级管理中的应用专家共识组. 降钙素原在成人下呼吸道感染性疾病分级管理中的应用专家共识[J]. 中华急诊医学杂志,2021, 30(4): 393-401.
6 降钙素原急诊临床应用专家共识组. 降钙素原(PCT)急诊临床应用的专家共识[J]. 中华急诊医学杂志,2012, 21(9): 944-951.
7 ISSELBACHER E M, PREVENTZA O, HAMILTON BLACK J 3rd, et al. 2022 ACC/AHA Guideline for the Diagnosis and Management of Aortic Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines [J]. Circulation, 2022, 146(24): e334-e482.
8 ZHENG X, CHEN S, ZHANG F, et al. Use of fibrin monomer and D-Dimer in assessing overt and nonovert disseminated intravascular coagulation [J]. Blood Coagul Fibrinolysis, 2021, 32(4): 248-252. doi:10.1097/mbc.0000000000001025
9 中国研究型医院学会血栓与止血专业委员会. D-二聚体实验室检测与临床应用中国专家共识[J]. 中华医学杂志,2023, 103(35): 2743-2756.
10 林岚,刘路浩,张磊,等. D?二聚体在胰肾联合移植术后移植胰血栓形成的预测价值 [J]. 实用医学杂志, 2022, 38(16): 2071-2075.
11 ALOISIO E, DOLCI A, PANTEGHINI M. Procalcitonin: Between evidence and critical issues [J]. Clin Chim Acta, 2019, 496: 7-12. doi:10.1016/j.cca.2019.06.010
12 王艳平,高文慧,伍艳婷,等. 肿瘤患者中性粒细胞缺乏伴发热临床疗效的影响因素分析 [J]. 实用医学杂志, 2024, 40 (18): 2597-2601.
13 KOCIOL R D, HORTON J R, FONAROW G C, et al. Admission, discharge, or change in B-type natriuretic peptide and long-term outcomes: Data from Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure (OPTIMIZE-HF) linked to Medicare claims [J]. Circ Heart Fail, 2011, 4(5): 628-636. doi:10.1161/circheartfailure.111.962290
14 余志华,余浩,祝炜,等. 老年新型冠状病毒肺炎患者心肌损伤标志物与NT-proBNP对临床结局的预测价值 [J]. 实用医学杂志, 2021, 37 (8): 965-969.
15 VON LODE P, RAINAHO J, PETTERSSON K. Quantitative, wide-range, 5-minute point-of-care immunoassay for total human chorionic gonadotropin in whole blood [J]. Clin Chem, 2004, 50(6): 1026-1035. doi:10.1373/clinchem.2004.031922
16 OH S W, KIM Y M, KIM H J, et al. Point-of-care fluorescence immunoassay for prostate specific antigen [J]. Clin Chim Acta, 2009, 406(1-2): 18-22. doi:10.1016/j.cca.2009.04.013
17 DAI J, ZHANG X, ZHOU J, et al. Clinical performance evaluation of serum amyloid A module of Mindray BC-7500CS automated hematology analyzer [J]. Transl Pediatr, 2023, 12(1): 20-30. doi:10.21037/tp-22-661
18 BECKER A, BACKMAN J T, ITKONEN O. Comparison of LC-MS/MS and chemiluminescent immunoassays for immunosuppressive drugs reveals organ dependent variation in blood cyclosporine a concentrations [J]. Clin Chim Acta, 2020, 508: 22-27. doi:10.1016/j.cca.2020.05.007
19 ZHAO H, HAN H, LIN Q, et al. A New Hematocrit Measurement Method Using a Chemiluminescence Biosensor and Its Application in a Chemiluminescence Immunoassay Platform for Myocardial Markers Detection with Whole Blood Samples [J]. Biosensors, 2022, 13(1):3. doi:10.3390/bios13010003
20 ZHANG Y, ZHUO H, YANG L, et al. A Corrective Method for Different Hematocrit Values of Whole Blood Samples on the Detection of Procalcitonin [J]. Clin Lab, 2022, 68(8). doi: 10.7754/Clin.Lab.2021.211119 .
21 LIN Y H, LI Y, SU B M, et al. Evaluation of a novel high sensitivity cardiac troponin I assay with whole blood [J]. Clin Chim Acta, 2020, 508: 273-276. doi:10.1016/j.cca.2020.05.036
22 FUKUDA T, KASAI H, KUSANO T, et al. A rapid and quantitative D-Dimer assay in whole blood and plasma on the point-of-care PATHFAST analyzer [J]. Thromb Res, 2007, 120(5): 695-701. doi:10.1016/j.thromres.2006.12.021
23 KOVAC M, RISCH L, THIEL S, et al. EDTA-Anticoagulated Whole Blood for SARS-CoV-2 Antibody Testing by Electrochemiluminescence Immunoassay (ECLIA) and Enzyme-Linked Immunosorbent Assay (ELISA) [J]. Diagnostics (Basel), 2020, 10(8):593. doi:10.3390/diagnostics10080593
24 LI C, ZUO J, LI Q, et al. One-step in situ solid-substrate-based whole blood immunoassay based on FRET between upconversion and gold nanoparticles [J]. Biosens Bioelectron, 2017, 92: 335-341. doi:10.1016/j.bios.2016.11.003
25 康可人,王华梁. 即时检测的临床应用与未来展望[J]. 中华检验医学杂志,2021,44(9):794-798.
26 KANG Y J, PARK H, PARK S B, et al. High Procalcitonin, C-Reactive Protein, and α-1 Acid Glycoprotein Levels in Whole Blood Samples Could Help Rapid Discrimination of Active Tuberculosis from Latent Tuberculosis Infection and Healthy Individuals [J]. Microorganisms, 2022, 10(10):1928. doi:10.3390/microorganisms10101928
27 WANG B, TANG R, WU S, et al. Clinical Value of Neutrophil CD64 Index, PCT, and CRP in Acute Pancreatitis Complicated with Abdominal Infection [J]. Diagnostics (Basel), 2022, 12(10):2409. doi:10.3390/diagnostics12102409
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