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在一个流行地区（老挝人民民主共和国沙拉湾省）评估 SD Bioline Dengue Duo 检测用于登革病毒（DENV）感染的诊断和分析性能。

Assessment of diagnostic and analytic performance of the SD Bioline Dengue Duo test for dengue virus (DENV) infections in an endemic area (Savannakhet province, Lao People's Democratic Republic).

机构信息

Department for Infectious Disease Epidemiology, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.

Department for Infectious Disease Diagnostics, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany.

出版信息

PLoS One. 2020 Mar 17;15(3):e0230337. doi: 10.1371/journal.pone.0230337. eCollection 2020.

DOI:10.1371/journal.pone.0230337
PMID:32182271
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7077838/
Abstract

BACKGROUND

Rapid tests detecting both dengue virus (DENV) NS1 antigen and anti-DENV IgM and IgG antibodies facilitate diagnosis of dengue fever (DF) in resource-poor settings.

METHODOLOGY/PRINCIPAL FINDINGS: 92 acute phase serum samples from patients with a PCR-confirmed DENV infection collected in Lao People's Democratic Republic (Lao PDR) in 2013 and 2015 were analyzed with the SD Bioline Dengue Duo test. A subset of 74 samples was additionally tested with the Platelia NS1 antigen test, the Panbio DENV μ-capture ELISA and the Panbio DENV IgG ELISA. IgM seroconversion was assayed using follow-up samples of 35 patients collected in the convalescent phase. 57.6%, 22.8% and 44.6% of acute phase serum samples tested positive in the SD Bioline Dengue Duo NS1, IgM, and IgG test, respectively. Diagnostic sensitivity of the SD Bioline Dengue Duo NS1 test strongly correlated with viral load, decreased rapidly over the acute phase of the disease, and was significantly reduced in presence of high anti-DENV IgG antibody titers resulting from secondary DENV infection. While a good concordance (Cohen's kappa 0.78) was found between the SD Bioline Dengue Duo NS1 test and the Platelia NS1 antigen ELISA, both the SD Bioline Dengue Duo IgM and IgG test displayed a significantly lower sensitivity than the corresponding ELISA tests.

CONCLUSIONS/SIGNIFICANCE: The SD Bioline Dengue Duo test is a valuable tool for diagnosis of DENV infections especially when analyzing early acute phase samples with high viral load. Nevertheless, in endemic areas, where secondary flavivirus infections are common, diagnostic sensitivity of the NS1 and IgM test components may be compromised.

摘要

背景

在资源匮乏的环境中，快速检测登革热病毒（DENV）NS1 抗原和抗 DENV IgM 和 IgG 抗体有助于登革热（DF）的诊断。

方法/主要发现：2013 年和 2015 年，在老挝人民民主共和国（老挝）采集了 92 例经 PCR 确诊的 DENV 感染的急性血清样本，用 SD Bioline Dengue Duo 检测进行分析。74 例样本的一部分还进行了 Platelia NS1 抗原检测、Panbio DENV μ-capture ELISA 和 Panbio DENV IgG ELISA 检测。对 35 例恢复期采集的患者随访样本进行了 IgM 血清转换检测。SD Bioline Dengue Duo NS1、IgM 和 IgG 检测中，57.6%、22.8%和 44.6%的急性血清样本呈阳性。SD Bioline Dengue Duo NS1 检测的诊断敏感性与病毒载量密切相关，在疾病的急性期中迅速下降，并且在继发的 DENV 感染导致高抗 DENV IgG 抗体滴度时显著降低。SD Bioline Dengue Duo NS1 检测与 Platelia NS1 抗原 ELISA 之间存在良好的一致性（Cohen's kappa 0.78），但 SD Bioline Dengue Duo IgM 和 IgG 检测的敏感性明显低于相应的 ELISA 检测。

结论/意义：SD Bioline Dengue Duo 检测是诊断 DENV 感染的一种有价值的工具，特别是在分析高病毒载量的早期急性样本时。然而，在流行地区，继发的黄病毒感染很常见，NS1 和 IgM 检测成分的诊断敏感性可能会受到影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/7077838/621a71e9caab/pone.0230337.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/7077838/1b8d7f850e88/pone.0230337.g001.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/7077838/3dd9b148f208/pone.0230337.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/7077838/621a71e9caab/pone.0230337.g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/7077838/1b8d7f850e88/pone.0230337.g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/7077838/ebcd24f12895/pone.0230337.g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/7077838/3dd9b148f208/pone.0230337.g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ec5f/7077838/621a71e9caab/pone.0230337.g004.jpg

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