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降钙素原时间分辨荧光免疫层析检测方法的建立及性能评价
Evaluation of a time-resolved fluorescence immunochromatography for procalcitonin
- 第三军医大学学报 2019年41卷第6期 页码：581-586
- 作者机构：
400037 重庆，陆军军医大学(第三军医大学)第二附属医院检验科
- 作者简介：
[ 蒲晓允，E-mail:puxiaoyong63@sina.com PU Xiaoyun, E-mail: puxiaoyong63@sina.com
- 基金信息：重庆市社会事业与民生保障科技创新专项(CSTC 2015 shmszx120091);第三军医大学新桥医院临床科研项目(2015YLC29)
DOI：10.16016/j.1000-5404.201810210
中图分类号： R446.112;R446.6收稿：2018-10-30，
修回：2019-01-10，
纸质出版：2019-03-30
- 稿件说明：
移动端阅览
黄德智, 应昊俊, 刘飞, 等. 降钙素原时间分辨荧光免疫层析检测方法的建立及性能评价[J]. 第三军医大学学报, 2019,41(6):581-586.
Dezhi HUANG, Haojun YING, Fei LIU, et al. Evaluation of a time-resolved fluorescence immunochromatography for procalcitonin[J]. Journal of Third Military Medical University, 2019, 41(6): 581-586.
黄德智, 应昊俊, 刘飞, 等. 降钙素原时间分辨荧光免疫层析检测方法的建立及性能评价[J]. 第三军医大学学报, 2019,41(6):581-586. DOI： 10.16016/j.1000-5404.201810210.
Dezhi HUANG, Haojun YING, Fei LIU, et al. Evaluation of a time-resolved fluorescence immunochromatography for procalcitonin[J]. Journal of Third Military Medical University, 2019, 41(6): 581-586. DOI： 10.16016/j.1000-5404.201810210.
摘要
目的
2
建立一种时间分辨荧光免疫层析定量降钙素原(procalcitonin
PCT)的检测方法并评价其性能。
方法
2
利用双抗体夹心法原理，以时间分辨荧光的纳米微球作为标记示踪物，运用免疫层析技术建立PCT免疫检测方法，并对该方法进行线性、灵敏度、精密度、特异性、相关性等性能指标的测定。
结果
2
本检测方法线性良好，线性范围为0.05~100 ng/mL，方程为Y=0.074 7X+0.524 6，
R
2
=0.990 4，灵敏度为0.03 ng/mL，批内精密度
CV
≤5.42%，批间精密度
CV
≤6.86%，与AE-180全自动化学发光免疫分析仪结果一致性较好，阳性符合率96.61%，阴性符合率94.44%，假阳性率5.56%，假阴性率3.39%和诊断符合率95.53%。
结论
2
本研究建立了PCT时间分辨免疫层析检测方法，该方法简便、经济、快速、并可以定量，各项性能参数均达到临床检测要求，可用于临床血清PCT浓度的检测。
Abstract
Objective
2
To evaluate the performance of a time-resolved fluorescence immunochromatographic assay for quantitative detection of procalcitonin (PCT).
Methods
2
Based on double antibody sandwich method and using time-resolved fluorescent nano-microspheres as the marker
we established an immunochromatographic assay for detecting PCT. We evaluated the performance of this method for PCT detection in terms of linearity
sensitivity
precision
specificity
and correlation.
Results
2
This immunochromatographic assay had a good linearity for PCT detection within the linear range of 0.05-100 ng/mL
and the linear equation was Y=0.074 7X+0.524 6 (
R
2
=0.990 4). The sensitivity of this method was 0.03 ng/mL with an inter-assay
precision
CV
≤5.42% and an intra-assay precision
CV
≤6.86%. The detection results by this method were well correlated with those by AE-180 automatic chemiluminescence immunoanalyzer and showed a positive coincidence rate of 96.61% and a negative coincidence rate of 94.44%; The false positive rate
false negative rate and diagnostic coincidence rate of this assay were 5.56%
3.39%
and 95.53%
respectively.
Conclusion
2
This time-resolved immunochromatographic assay allows simple
economic
rapid and quantifiable detection of PCT and shows a good performance for potential application in the detection for clinical serum samples.
关键词
Keywords
references
BOBILLO-PEREZ S, RODRÍGUEZ-FANJUL J, JORDAN GARCIA I. Is procalcitonin useful in pediatric critical care patients?[J]. Biomark Insights, 2018, 13: 117727191879 2244. DOI: 10.1177/1177271918792244.
阴赪宏, 王超, 文艳, 等.降钙素原及其在脓毒症诊断中的应用[J].中华急诊医学杂志, 2003, 12(5): 357-358. DOI: 10.3760/j.issn:1671-0282.2003.05.036.
YIN C H, WANG C, WEN Y, et al . Procalcitonin and its application in the diagnosis of sepsis[J ] . Chin J Emerg Med, 2003, 12(5): 357-358. DOI: 10.3760/j.issn:1671-0282.2003.05.036.
SHIN H J, KANG S H, MOON H S, et al . Serum procalcitonin levels can be used to differentiate between inflammatory and non-inflammatory diarrhea in acute infectious diarrhea[J ] . Medicine, 2018, 97(32): e11795. DOI: 10.1097/MD.0000000000011795.
ASSICOT M, GENDREL D, CARSIN H, et al . High serum procalcitonin concentrations in patientswith sepsis and infection[J ] . Lancet, 1993, 341(8844): 515-518. DOI: 10.1016/0140-6736(93)90277-N.
DAVIES J. Procalcitonin[J]. J Clin Pathol, 2015, 68(9): 675-679.
MUSTAFIC S, BRKIC S, PRNJAVORAC B, et al . Diagnostic and prognostic value of procalcitonin in patients with sepsis[J ] . Med Glas (Zenica), 2018, 15(2): 93-100. DOI: 10.1016/j.ijid.2008.05.1301.
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. DOI: 10.3760/cma.j.issn.1671-0282.2012.09.005.
Expert Consensus Group on the Emergency Clinical Application of Procalcitonin. Expert consensus on emergency clinical application of procalcitonin (PCT)[J]. Chin J Emerg Med, 2012, 21(9): 944-951. DOI: 10.3760/cma.j.issn.1671-0282.2012.09.005.
周杰, 龙莉, 周俊卿.降钙素原检测方法以及其临床意义研究的进展[J].医疗装备, 2017, 30(20): 201-202.
ZHOU J, LONG L, ZHOU J Q. Progress in the detection of procalcitonin and its clinical significance[J]. Med Equipment, 2017, 30(20): 201-202.
朱美英, 曹鄂洪.降钙素原的检测和应用——《感染相关生物标志物临床意义解读专家共识》解读[J].上海医药, 2018, 39(1): 14-18.
ZHU M Y, CAO E H. Detection and application of procalcitonin—interpretation for expert consensus on clinical signifcance interpretation of infection-related biomarkers[J]. Shanghai Pharmaceutical, 2018, 39(1): 14-18.
LEE T, 杨发青, 王朝南, 等.降钙素原快速定量检测试剂的研制及性能评估[J].天津科技, 2013(3): 82-84. DOI: 10.3969/j.issn.1006-8945.2013.03.034.
LEE T, YANG F Q, WANG C N, et al . Development and performance evaluation of procalcitonin quantitative rapid test kit[J ] . Tianjin Sci Technol, 2013(3): 82-84. DOI: 10.3969/j.issn.1006-8945.2013.03.034.
李鲁平, 于洋, 谷海峰, 等.降钙素原上转发光免疫层析定量检测方法的建立[J].中华检验医学杂志, 2014, 37(2): 144-146. DOI: 10.3760/cma.j.issn.1009-9158.2014.02.017.
LI L P, YU Y, GU H F, et al . Establishment of quantitative detection method for procalcitonin by up-converting immunochromatographic assay[J ] . Chin J Lab Med, 2014, 37(2): 144-146. DOI: 10.3760/cma.j.issn.1009-9158.2014.02.017.
仲月, 朱瑾, 冯慧, 等.定量检测血清降钙素原免疫层析试纸条的研制[J].南京工业大学学报(自然科学版), 2016, 38(4): 125-129. DOI: 10.3969/j.issn.1671-7627.2016.04.021.
ZHONG Y, ZHU J, FENG H, et al . Development of immunochromatography test strips for quantitative procalcitonin detection in serum[J ] . J Nanjing Univ Technol (Nat Sci Ed), 2016, 38(4): 125-129. DOI: 10.3969/j.issn.1671-7627.2016.04.021.
刘献文, 赵盛. PCT荧光免疫层析检测方法的建立及性能评价[J].国际检验医学杂志, 2017, 38(23): 3324-3326. DOI: 10.3969/j.issn.1673-4130.2017.23.039.
LIU X W, ZHAO S. Establishment and performance evaluation of fluorescence immunochromatography for procalcitonin detection[J]. Int J Lab Med, 2017, 38(23): 3324-3326. DOI: 10.3969/j.issn.1673-4130.2017.23.039.
SHAO X, WANG C, XIE C, et al . Rapid and sensitive lateral flow immunoassay method for procalcitonin (PCT) based on time-resolved immunochromatography[J ] . Sensors, 2017, 17(3): 480. DOI: 10.3390/s17030480.
余皓, 徐良, 漆晓萍.量子点标记免疫层析技术检测血液中的降钙素原[J].分析化学, 2014, 42(11): 1592-1597. DOI: 10.11895/j.issn.0253-3820.140453.
YU H, XU L, QI X P. Detection of procalcitonin in blood by quantum-dots-labeled immunochromatography[J]. Chin J Anal Chem, 2014, 42(11): 1592-1597. DOI: 10.11895/j.issn.0253-3820.140453.
QI X, HUANG Y, LIN Z, et al . Dual-quantum-dots-labeled lateral flow strip rapidly quantifies procalcitonin and C-reactive protein[J ] . Nanoscale Res Lett, 2016, 11: 167. DOI: 10.1186/s11671-016-1383-z.
HUANG X, AGUILAR Z P, XU H, et al . Membrane-based lateral flow immunochromatographic strip with nanoparticles as reporters for detection: A review[J ] . Biosens Bioelectron, 2016, 75: 166-180. DOI: 10.1016/j.bios.2015.08.032.
史咏梅, 何晖, 冯子力, 等.时间分辨荧光免疫分析技术在医学领域的应用[J].国际检验医学杂志, 2015, 36(19): 2866-2869. DOI:10.3969/j.issn.1673-4130.2015.19.039.
SHI Y M, HE H, FENG Z L, et al . Application of time-resolved fluorescence immunoassay in medical field[J ] . Int J Lab Med, 2015, 36(19): 2866-2869. DOI: 10.3969/j.issn.1673-4130.2015.19.039.
冯仁丰.临床检验质量管理技术基础[M]. 2版.上海:上海科学技术文献出版社, 2007.
FENG R F. Technical basis of clinical laboratory quality management[M]. 2nd Edition. Shanghai: Shanghai Science and Technology Literature Publishing House, 2007.
李阳, 王云龙.免疫层析技术的研究进展[J].中国卫生检验杂志, 2015, 25(22): 3978-3980.
LI Y, WANG Y L. Research progress of immunochromatographic technology[J]. Chin J Health Lab Tech, 2015, 25(22): 3978-3980.
BAHADIR E B, SEZGINTVRK M K. Lateral flow assays: principles, designs and labels[J]. TrAC Trends Anal Chem, 2016, 82: 286-306. DOI: 10.1016/j.trac.2016.06.006.
HARMA H, SOUKKA T, LOVGREN T. Europium nanoparticles and time-resolved fluorescence for ultrasensitive detection of prostate-specific antigen[J]. Clin Chem, 2001, 47(3): 561-568. DOI: 10.1016/S0009-9120(01)00197-7.
LIANG R L, XU X P, LIU T C, et al . Rapid and sensitive lateral flow immunoassay method for determining alpha fetoprotein in serum using europium (Ⅲ) chelate microparticles-based lateral flow test strips[J ] . Anal Chim Acta, 2015, 891: 277-283. DOI: 10.1016/j.aca.2015.07.053.
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