Evaluation of a time-resolved fluorescence immunochromatography for procalcitonin

Dezhi HUANG; Haojun YING; Fei LIU; Xiaoyun PU

doi:10.16016/j.1000-5404.201810210

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Evaluation of a time-resolved fluorescence immunochromatography for procalcitonin

Basic Medicine | 更新时间：2026-01-09

- Evaluation of a time-resolved fluorescence immunochromatography for procalcitonin
- Journal of Third Military Medical University Vol. 41, Issue 6, Pages: 581-586(2019)
- 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：
- 基金信息：
  
  the Key Project of Social Welfare of Chongqing(CSTC 2015 shmszx120091);the Clinical Research Project of Xinqiao Hospital of Third Military Medical University(2015YLC29)
- DOI：10.16016/j.1000-5404.201810210
  CLC： R446.112;R446.6
- Received：30 October 2018，
  
  Revised：2019-01-10，
  
  Published：30 March 2019
- 稿件说明：
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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：

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

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

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

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，

=0.990 4，灵敏度为0.03 ng/mL，批内精密度

≤5.42%，批间精密度

≤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

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

To evaluate the performance of a time-resolved fluorescence immunochromatographic assay for quantitative detection of procalcitonin (PCT).

Methods

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

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 (

=0.990 4). The sensitivity of this method was 0.03 ng/mL with an inter-assay

precision

≤5.42% and an intra-assay precision

≤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

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

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