Chi Hanesh F, Etafo Johnson, Fonkeng Fritz, Olufunke Gbenga-Ayeni, Ireneh Ronke, Abejegah Chukwuyem, Owhin Sampson, Bausch Daniel G, Vessiere Aurelia, Agogo Emmanuel, Emperador Devy M, Nelson Adedosu A
FIND, Geneva, Switzerland.
Federal Medical Centre Owo, Owo, Nigeria.
PLOS Glob Public Health. 2025 Apr 21;5(4):e0004405. doi: 10.1371/journal.pgph.0004405. eCollection 2025.
Lassa fever is a zoonotic disease found in several countries across West Africa, with estimates of up to 300,000 infections and 10,000 deaths yearly. The highest incidence is in Nigeria. Suspected cases are often seen in areas with limited infrastructure and diagnostics capacity, hence the availability of an accurate rapid diagnostic test (RDT) that could be used in the community would be an important public health tool. Unfortunately, few RDTs for Lassa fever exist and have not been thoroughly validated. Toward that end, we conducted a Phase 2 performance evaluation to assess the diagnostic accuracy of the ReLASV Pan-Lassa Antigen Rapid Test (Zalgen Labs, Frederick, MD, USA) using archived, frozen whole blood, plasma, and serum samples collected from individuals in Nigeria to determine its suitability for widespread use as a screening tool for Lassa fever. The overall performance of this RDT was measured against the reference test, the Altona RealStar LASV real-time reverse transcription polymerase chain reaction 2.0 (Altona Diagnostics, Hamburg, Germany). The sensitivity and specificity of the ReLASV Pan-Lassa Antigen Test were 65% and 50.7%, respectively. The low diagnostic accuracy indicated in our and other independent evaluations of the ReLASV Pan-Lassa Antigen Rapid Test suggests that this test, at least until further developed, refined, and validated, is not suitable for making critical diagnostic or treatment decisions for Lassa fever, at least for lineages that commonly circulate in Nigeria. These findings underscore the importance of thoroughly assessing the performance characteristics of tests to ensure their reliability and accuracy.
拉沙热是一种人畜共患疾病，在西非多个国家均有发现，据估计每年感染人数高达30万，死亡人数达1万。发病率最高的是尼日利亚。疑似病例常见于基础设施和诊断能力有限的地区，因此，一种可在社区使用的准确快速诊断检测（RDT）将是一项重要的公共卫生工具。不幸的是，针对拉沙热的RDT很少，且尚未得到充分验证。为此，我们进行了一项2期性能评估，以评估ReLASV泛拉沙病毒抗原快速检测（美国马里兰州弗雷德里克市Zalgen实验室）的诊断准确性，该评估使用了从尼日利亚个体采集的存档冷冻全血、血浆和血清样本，以确定其作为拉沙热筛查工具广泛使用的适用性。该RDT的整体性能与参考检测方法——阿尔托纳RealStar LASV实时逆转录聚合酶链反应2.0（德国汉堡阿尔托纳诊断公司）进行了对比。ReLASV泛拉沙病毒抗原检测的灵敏度和特异性分别为65%和50.7%。我们以及其他对ReLASV泛拉沙病毒抗原快速检测的独立评估中所显示的低诊断准确性表明，至少在进一步研发、完善和验证之前，该检测不适用于为拉沙热做出关键的诊断或治疗决策，至少对于在尼日利亚常见传播的谱系来说是这样。这些发现强调了全面评估检测性能特征以确保其可靠性和准确性的重要性。
