Laboratory needs for research response

Public health emergencies are complex and dynamic situations. Outbreaks vary in size and geographical location, and the populations affected may not be limited to humans. Over the last decade, there has been a growing recognition of the need to respond aggressively and comprehensively as early as possible to minimize the potential public health and economic impacts. At the most basic level, laboratory testing identifies infected individuals, animals, and/or contaminated environmental inputs. Laboratories provide data to inform control measures, guide clinical care, and enable response research. For clinical studies, the laboratory may generate data that determine participant eligibility, assist with monitoring participant safety and well-being, or address primary and secondary endpoints. The laboratory's capacity may limit the study enrollment rate and the completion of essential analyses. Laboratories must be able to deploy rapidly, adapt to changing needs, and generate the highest quality data to protect public health and response efforts. Reliable clinical laboratory data are essential in the determination of candidate therapeutic and vaccine safety and efficacy. In this chapter, we discuss the factors that should be considered for planning and establishing laboratory capabilities, the roles of the laboratory in conducting emergency response research, unique challenges of low-resource environments, potential challenges in establishing and maintaining high-quality laboratory support, as well as recent advances in response-based laboratory science.