Infectious disease outbreaks, even small or remote ones, may be global threats and require a swift public health response. Accurate, accessible, and robust diagnostic tests are critical for patient management and public health response. However, when a new threat emerges, such as the Zika virus, diagnostic tests may not exist and have to be rapidly developed and implemented by public health and clinical laboratories to support response efforts.
During emergencies, access to samples and reference materials needed for test development, performance evaluation, and deployment is a challenge for Centers for Disease Control and Prevention (CDC) programs, public health partners, and private diagnostics manufacturers. A recent GAO report (GAO-17-445) showed that manufacturers of diagnostic assays experienced difficulty obtaining Zika positive clinical specimens, hindering the development of new Zika diagnostics.
To address the need for rapid access to outbreak-related samples, the CDC is interested in developing the capability to rapidly document informed consent and collect specimens from affected patients during outbreaks of infectious disease or public health emergencies.
CDC is seeking information from companies and other organizations about their capability and capacity to deploy to the site of a domestic or international outbreak or public health emergency, obtain informed consent, collect specimens (blood, urine, swabs, etc.) from identified patients, and safely ship these specimens to CDC in accordance with all applicable local, state, and federal and/or international laws, and regulations.
Additionally, the agency is seeking to obtain information, needs, capabilities, constraints, capacities, and requirements of those vendors and companies who do have an interest (or potential interest) in providing the needed services.
Further information is available via Solicitation Number: 75D301-19-Q-70417.