Klein Antonia, Fahrion Anna, Finke Stefan, Eyngor Marina, Novak Shiri, Yakobson Boris, Ngoepe Ernest, Phahladira Baby, Sabeta Claude, De Benedictis Paola, Gourlaouen Morgane, Orciari Lillian A, Yager Pamela A, Gigante Crystal M, Knowles M Kimberly, Fehlner-Gardiner Christine, Servat Alexandre, Cliquet Florence, Marston Denise, McElhinney Lorraine M, Johnson Trudy, Fooks Anthony R, Müller Thomas, Freuling Conrad M
Friedrich-Loeffler-Institut (FLI), Federal Research Institute for Animal Health, Institute of Molecular Virology and Cell Biology, 17493 Greifswald-Insel Riems, Germany.
Kimron Veterinary Institute (KVI), Veterinary Services and Animal Health, P.O. Box 12, Beit Dagan 50250, Israel.
Trop Med Infect Dis. 2020 Jan 18;5(1):13. doi: 10.3390/tropicalmed5010013.
As a neglected zoonotic disease, rabies causes approximately 5.9 × 10 human deaths annually, primarily affecting low- and middle-income countries in Asia and Africa. In those regions, insufficient surveillance is hampering adequate medical intervention and is driving the vicious cycle of neglect. Where resources to provide laboratory disease confirmation are limited, there is a need for user-friendly and low-cost reliable diagnostic tools that do not rely on specialized laboratory facilities. Lateral flow devices (LFD) offer an alternative to conventional diagnostic methods and may strengthen control efforts in low-resource settings. Five different commercially available LFDs were compared in a multi-centered study with respect to their diagnostic sensitivity and their agreement with standard rabies diagnostic techniques. Our evaluation was conducted by several international reference laboratories using a broad panel of samples. The overall sensitivities ranged from 0% up to 62%, depending on the LFD manufacturer, with substantial variation between the different laboratories. Samples with high antigen content and high relative viral load tended to test positive more often in the Anigen/Bionote test, the latter being the one with the best performance. Still, the overall unsatisfactory findings corroborate a previous study and indicate a persistent lack of appropriate test validation and quality control. At present, the tested kits are not suitable for in-field use for rabies diagnosis, especially not for suspect animals where human contact has been identified, as an incorrect negative diagnosis may result in human casualties. This study points out the discrepancy between the enormous need for such a diagnostic tool on the one hand, and on the other hand, a number of already existing tests that are not yet ready for use.
作为一种被忽视的人畜共患疾病，狂犬病每年导致约5.9×10人死亡，主要影响亚洲和非洲的低收入和中等收入国家。在这些地区，监测不足阻碍了适当的医疗干预，并推动了被忽视的恶性循环。在提供实验室疾病确诊资源有限的地方，需要用户友好且低成本的可靠诊断工具，这些工具不依赖专门的实验室设施。横向流动装置（LFD）为传统诊断方法提供了一种替代方案，可能会加强资源匮乏地区的防控工作。在一项多中心研究中，对五种不同的市售LFD在诊断敏感性以及与标准狂犬病诊断技术的一致性方面进行了比较。我们的评估由几个国际参考实验室使用大量样本进行。总体敏感性范围从0%到62%不等，这取决于LFD制造商，不同实验室之间存在很大差异。抗原含量高和相对病毒载量高的样本在Anigen/Bionote检测中往往更常呈阳性，后者是性能最佳的一种。尽管如此，总体上不令人满意的结果证实了先前的一项研究，并表明持续缺乏适当的测试验证和质量控制。目前，所测试的试剂盒不适合用于现场狂犬病诊断，特别是对于已确定有人接触的疑似动物，因为错误的阴性诊断可能导致人员伤亡。这项研究指出了一方面对这种诊断工具的巨大需求与另一方面许多现有测试尚未准备好投入使用之间的差异。
