Pollock Nira R, Wonderly Betsy
Department of Laboratory Medicine, Boston Children's Hospital. Harvard Medical School, Boston, Massachusetts, USA
Foundation for Innovative New Diagnostics, Geneva, Switzerland.
J Clin Microbiol. 2017 May;55(5):1255-1261. doi: 10.1128/JCM.00053-17. Epub 2017 Mar 1.
Inadequate access to rapid testing for Ebola virus disease during the 2014-to-2016 outbreak led to an explosion in the development of diagnostics that could be performed at or near the point of care and by less-experienced operators, leading in turn to an acute need for novel test evaluation. Here, we present the challenges to development and evaluation of novel diagnostics in an emergency setting and suggestions for potential new "global emergency standards" to address them.
在2014年至2016年埃博拉病毒病疫情期间,快速检测手段难以获取,这促使人们大力研发能够在现场或接近现场由经验较少的操作人员进行的诊断方法,进而引发了对新型检测评估的迫切需求。在此,我们阐述了在紧急情况下新型诊断方法研发与评估所面临的挑战,并针对如何应对这些挑战提出了潜在的新“全球应急标准”建议。