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免疫层析法与化学发光微粒子免疫分析法在梅毒诊断中的比较经验

Lessons from a comparison of immuno-chromatographic and chemiluminescent micro-particle immunoassay in the diagnosis of syphilis.

作者信息

Masenga Sepiso K, Mweemba Mercy, Kachele Annie, Chalubemba Yahns, Toloka Paul, Hamooya Benson M

机构信息

Pathology Laboratory Department, Research Section, Livingstone Central Hospital, Akapelwa Street, P.O. Box 60091, Livingstone, Zambia.

Department of Biomedical Sciences, School of Health Sciences, University of Zambia, P.O. Box 50110, Lusaka, Zambia.

出版信息

BMC Res Notes. 2018 Oct 4;11(1):701. doi: 10.1186/s13104-018-3808-5.

DOI:10.1186/s13104-018-3808-5
PMID:30286790
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6172779/
Abstract

OBJECTIVE

To synthesize lessons from comparison of results obtained from the immuno-chromatographic SD Bioline testing method and the chemiluminescent micro-particle immunoassay Architect in the diagnosis of syphilis at Livingstone Central hospital laboratory.

RESULTS

The specificity and sensitivity of SD Bioline syphilis 3.0 against the chemiluminescent immunoassay using the Architect syphilis Treponema pallidum (TP) was 85.3% and 91.3% respectively with substantial agreement between the two test methods (88%, ĸ  = 0.76; p < 0.0005). We recommend further comprehensive study with a larger sample size and clinical details to ascertain the validity of our findings. We also recommend using a non-treponemal test with the current treponemal tests being used to aid diagnosis.

摘要

目的

综合分析利文斯通中央医院实验室采用免疫层析法SD Bioline检测方法与化学发光微粒子免疫分析法Architect在梅毒诊断中的结果比较。

结果

SD Bioline梅毒3.0检测法相对于使用Architect梅毒螺旋体(TP)化学发光免疫分析法的特异性和敏感性分别为85.3%和91.3%,两种检测方法之间具有高度一致性(88%,ĸ = 0.76;p < 0.0005)。我们建议开展进一步的综合研究,扩大样本量并提供临床细节,以确定我们研究结果的有效性。我们还建议在当前使用的梅毒螺旋体检测方法基础上,结合非梅毒螺旋体检测方法辅助诊断。

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本文引用的文献

1
Serologic Testing for Syphilis: Benefits and Challenges of a Reverse Algorithm.梅毒血清学检测:反向算法的益处与挑战
Clin Microbiol Newsl. 2014 Dec 15;36(24):195-202. doi: 10.1016/j.clinmicnews.2014.12.001.
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STARD 2015 guidelines for reporting diagnostic accuracy studies: explanation and elaboration.《STARD 2015诊断准确性研究报告指南:解释与详述》
BMJ Open. 2016 Nov 14;6(11):e012799. doi: 10.1136/bmjopen-2016-012799.
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Evaluation of SD BIOLINE Syphilis 3.0 for Rapid Diagnosis of Syphilis: Report from a Regional Sexually Transmitted Infection Reference Laboratory in North India.评估SD BIOLINE梅毒3.0用于梅毒快速诊断:来自印度北部一家地区性传播感染参考实验室的报告。
J Lab Physicians. 2016 Jan-Jun;8(1):36-40. doi: 10.4103/0974-2727.176239.
4
Evaluation of different confirmatory algorithms using seven treponemal tests on Architect Syphilis TP-positive/RPR-negative sera.使用七种梅毒螺旋体检测方法对Architect梅毒螺旋体检测呈阳性/快速血浆反应素环状卡片试验呈阴性的血清进行不同确证算法的评估。
Eur J Clin Microbiol Infect Dis. 2015 Oct;34(10):2041-8. doi: 10.1007/s10096-015-2449-z. Epub 2015 Jul 18.
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Recent trends in the serologic diagnosis of syphilis.梅毒血清学诊断的近期趋势
Clin Vaccine Immunol. 2015 Feb;22(2):137-47. doi: 10.1128/CVI.00681-14. Epub 2014 Nov 26.
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Evaluation of a Rapid Immunochromatographic Treponemal Antibody Test Comparing the Treponema Pallidum Particle Agglutination Assay.一种快速免疫层析梅毒螺旋体抗体检测方法与梅毒螺旋体颗粒凝集试验的比较评估
J Clin Lab Anal. 2015 Sep;29(5):383-6. doi: 10.1002/jcla.21783. Epub 2014 Nov 10.
7
Factors associated with serological cure and the serofast state of HIV-negative patients with primary, secondary, latent, and tertiary syphilis.与原发性、继发性、潜伏性和三期梅毒的 HIV 阴性患者的血清学治愈和血清固定状态相关的因素。
PLoS One. 2013 Jul 23;8(7):e70102. doi: 10.1371/journal.pone.0070102. Print 2013.
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Interrater reliability: the kappa statistic.组内一致性:kappa 统计量。
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Syphilis: a reemerging infection.梅毒:一种再现的传染病。
Am Fam Physician. 2012 Sep 1;86(5):433-40.
10
Which algorithm should be used to screen for syphilis?应该使用哪种算法来筛查梅毒?
Curr Opin Infect Dis. 2012 Feb;25(1):79-85. doi: 10.1097/QCO.0b013e32834e9a3c.