Department of Virology, Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo; Service de Microbiologie, Département de Biologie Médicale, Cliniques Universitaires de Kinshasa, Université de Kinshasa, Kinshasa, Democratic Republic of the Congo.
Department of Virology, Institut National de Recherche Biomédicale, Kinshasa, Democratic Republic of the Congo; Service de Microbiologie, Département de Biologie Médicale, Cliniques Universitaires de Kinshasa, Université de Kinshasa, Kinshasa, Democratic Republic of the Congo.
Lancet Infect Dis. 2022 Jun;22(6):891-900. doi: 10.1016/S1473-3099(21)00675-7. Epub 2022 Mar 14.
The Democratic Republic of the Congo has confronted 13 outbreaks of Ebola virus disease since 1976. Rapid diagnostic tests (RDTs) detecting viral antigens have been developed to circumvent difficulties encountered with RT-PCR for diagnosis in remote low-resource settings, but there is still uncertainty about their performance characteristics and usability during outbreaks. We aimed to assess the field performance of three antigen detection RDTs compared with the gold-standard Cepheid GeneXpert Ebola assay results.
We conducted a retrospective, multicentre observational study using complete and de-identified databases of five mobile laboratories (managed by the Institut National de Recherche Biomédicale) to assess the performance of three Ebola virus disease RDTs (QuickNavi-Ebola, OraQuick Ebola Rapid Antigen Test, and Coris EBOLA Ag K-SeT rapid test) run on blood samples of patients with suspected Ebola virus disease in direct comparison with the Cepheid GeneXpert Ebola assay reference test during the 2018-20 outbreak in the eastern Democratic Republic of the Congo. We estimated the sensitivity and specificity of each test through generalised linear mixed models against the GeneXpert Ebola assay reference test and corrected for cycle threshold value and random site effects.
719 (7·9%) of 9157 samples had a positive GeneXpert Ebola assay result. The QuickNavi-Ebola RDT had a sensitivity of 87·4% (95% CI 63·6-96·8) around the mean cycle threshold value and a specificity of 99·6% (99·3-99·8). The OraQuick Ebola Rapid Antigen Test had a sensitivity of 57·4% (95% CI 38·8-75·8) and specificity of 98·3% (97·5-99·0), and the Coris EBOLA Ag K-SeT rapid test had a sensitivity of 38·9% (23·0-63·6) against the GeneXpert Ebola assay reference and specificity of 97·4% (85·3-99·6). The QuickNavi-Ebola RDT showed a robust performance with good sensitivity, particularly with increasing viral loads (ie, low cycle threshold values), and specificity.
The three RDTs evaluated did not achieve the desired sensitivity and specificity of the WHO target product profile. Although the RDTs cannot triage and rule out Ebola virus infection among clinical suspects, they can still help to sort people with suspected Ebola virus disease into high-risk and low-risk groups while waiting for GeneXpert Ebola assay reference testing.
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For the French translation of the abstract see Supplementary Materials section.
自 1976 年以来，刚果民主共和国已经发生了 13 次埃博拉病毒病疫情。为了克服在偏远的资源匮乏环境中使用 RT-PCR 进行诊断所遇到的困难，已经开发出了快速诊断检测（RDT）来检测病毒抗原，但对于它们在疫情期间的性能特征和可用性仍存在不确定性。我们旨在评估三种抗原检测 RDT 在与金标准 Cepheid GeneXpert 埃博拉检测结果对比时的现场性能。
我们进行了一项回顾性、多中心观察性研究，使用五个流动实验室（由国家生物医学研究所管理）的完整且去识别数据库，评估了三种埃博拉病毒病 RDT（QuickNavi-Ebola、OraQuick 埃博拉快速抗原检测和 Coris EBOLA Ag K-SeT 快速检测）在刚果民主共和国东部 2018-20 年疫情期间对疑似埃博拉病毒病患者的血液样本中的表现，与 Cepheid GeneXpert 埃博拉检测参考测试进行直接比较。我们通过广义线性混合模型估计每种测试的敏感性和特异性，并针对循环阈值值和随机地点效应进行校正。
在 9157 个样本中，有 719 个（7.9%）的样本 GeneXpert 埃博拉检测结果呈阳性。QuickNavi-Ebola RDT 的敏感性在平均循环阈值值周围为 87.4%（95%CI63.6-96.8），特异性为 99.6%（99.3-99.8）。OraQuick 埃博拉快速抗原检测的敏感性为 57.4%（95%CI38.8-75.8），特异性为 98.3%（97.5-99.0），而 Coris EBOLA Ag K-SeT 快速检测的敏感性为 38.9%（23.0-63.6），特异性为 97.4%（85.3-99.6）。QuickNavi-Ebola RDT 的表现稳健，具有良好的敏感性，特别是在病毒载量增加（即低循环阈值值）时，特异性也很好。
评估的三种 RDT 并未达到世卫组织目标产品概况的预期敏感性和特异性。尽管 RDT 不能在临床疑似病例中进行分诊和排除埃博拉病毒感染，但在等待 GeneXpert 埃博拉检测参考测试时，它们仍然可以帮助将疑似埃博拉病毒病患者分为高风险和低风险人群。
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