Diagnostic Accuracy of 3 Mpox Lateral Flow Assays for Antigen Detection, Democratic Republic of the Congo and United Kingdom

IF 7.2 2区医学 Q1 IMMUNOLOGY

Emerging Infectious Diseases Pub Date : 2025-05-02 DOI:10.3201/eid3106.250166

Elie Ishara-Nshombo, Anushri Somasundaran, Alessandra Romero-Ramirez, Konstantina Kontogianni, Daniel Mukadi-Bamuleka, Marithé Mukoka-Ntumba, Emile Muhindo-Milonde, Hugues Mirimo-Nguee, Jacob Parkes, Yusra Hussain, Susan Gould, Christopher T. Williams, Dominic Wooding, Juvenal Nkeramahame, Mikaela Watson, Hayley E. Hardwick, Malcolm G. Semple, John Kenneth Baillie, Jake Dunning, Thomas E. Fletcher, Thomas Edwards, Devy M. Emperador, Hugo Kavunga-Membo, Ana Isabel Cubas-Atienzar

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引用次数: 0

Abstract

The ongoing outbreaks of mpox highlight the urgent need for a rapid and low-cost diagnostic test to accurately detect and control this emerging disease. We estimated the analytical sensitivity using viral culture of the monkeypox virus clade IIb lineage and clinical diagnostic performance of 3 antigen detection rapid diagnostic tests (Ag-RDT) by using skin swab samples and upper-respiratory swab samples from mpox patients in the Democratic Republic of the Congo and the United Kingdom. The analytical limit of detection was 1.0 × 10⁴ plaque-forming units/mL, fulfilling World Health Organization recommendations. Specificity of the 3 Ag-RDTs was 100%, but sensitivity was estimated at 0.00%–15.79% using skin samples and 0.00% using respiratory samples. None of the 3 Ag-RDTs reached the World Health Organization’s target clinical sensitivity, and we do not recommend them as diagnostic or screening tools for suspected mpox cases. Accurate Ag-RDTs for mpox diagnosis remain urgently needed.

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抗原检测的3种Mpox横向流动试验的诊断准确性，刚果民主共和国和英国

目前的麻疹疫情突出表明，迫切需要一种快速和低成本的诊断检测方法，以准确发现和控制这一新出现的疾病。我们使用猴痘病毒分支IIb谱系的病毒培养来评估分析敏感性，并通过使用刚果民主共和国和英国的猴痘患者的皮肤拭子样本和上呼吸道拭子样本来评估3种抗原检测快速诊断试验（sag - rdt）的临床诊断性能。分析检出限为1.0 × 104菌斑形成单位/mL，符合世界卫生组织推荐标准。3种ag - rdt的特异性为100%，但皮肤样本和呼吸样本的敏感性分别为0.00% - 15.79%和0.00%。3种ag - rdt均未达到世界卫生组织的目标临床敏感性，因此我们不建议将其作为疑似m痘病例的诊断或筛查工具。仍然迫切需要用于m痘诊断的准确的ag - rdt。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Emerging Infectious Diseases 医学-传染病学

CiteScore

17.30

自引率

1.70%

发文量

505

审稿时长

1 months

期刊介绍： Emerging Infectious Diseases is a monthly open access journal published by the Centers for Disease Control and Prevention. The primary goal of this peer-reviewed journal is to advance the global recognition of both new and reemerging infectious diseases, while also enhancing our understanding of the underlying factors that contribute to disease emergence, prevention, and elimination. Targeted towards professionals in the field of infectious diseases and related sciences, the journal encourages diverse contributions from experts in academic research, industry, clinical practice, public health, as well as specialists in economics, social sciences, and other relevant disciplines. By fostering a collaborative approach, Emerging Infectious Diseases aims to facilitate interdisciplinary dialogue and address the multifaceted challenges posed by infectious diseases.