Description:
Background: CDC has both domestic and international laboratory programs that provide clinical specimen testing for the detection of known and emerging infections, chemical, or radiological agents that pose global health threats. Current methods for collection, storage, and transport of biological specimens are expensive and labor and material intensive. Clinical specimens are often collected by highly trained phlebotomists and other health professionals, transported to laboratories in compliance with shipping regulations for potentially infectious specimens, and shipped cold chain to ensure specimen integrity. There is a need for novel, minimally invasive, low-complexity specimen collection, and preservation technologies.
Project Goal: CDC is interested in improving capabilities in low-complexity methods to collect, preserve, and safely transport clinically relevant specimens or samples for endemic/outbreak surveillance and chemical or radionuclide exposure. Additionally, these technologies could translate well to low resource settings or home health care environments. High quality proposals must address the following priority area and preference will be given to proposals that can address any additional areas of interest. Specifically excluded is research that only incrementally advances the current state of the art. Proposals that aim to simply integrate existing methods and technologies will be considered non-responsive.
Priority Area of Interest:
Technologies/methods that allow for the self-collection of blood specimens in all point of care/contact settings without the necessity for trained personnel, require minimal materials/reagents, yet maintain the integrity of either nucleic acids (DNA and RNA), protein analytes (antigens, enzyme, and antibody), or both, at ambient temperature (0-40oC) for ≥14 days, and allow for inexpensive storage and transportation.
Nucleic acids and/or protein analytes must be compatible/interoperable with downstream assays including functional (activity) assays, real-time PCR, real-time RT-PCR, ELISA, sequencing, mass spectroscopy, and serology, as appropriate.
Additional Areas of interest:
Compatibility of the technologies/methods with additional biological specimens (e.g., serum, sputum, nasopharyngeal swabs/aspirates, whole blood or urine).
When warranted, inactivation of infectious agents by methods that do not interfere with detection/measurement of the diagnostic target, to allow laboratory testing under BSL2 conditions.
Suitability for testing a broad range of target analytes (including but not limited to, antibodies, antigens, cytokines, enzymes, carbohydrates, small molecules, metals, radionuclides, lipids, and nucleic acids) at clinically relevant concentrations. Potential for FDA clearance or CLIA waiver for use with diagnostics in low resource settings, patient homes, and first responder use, Potential for Point of Care or Point of Need settings or laboratory environments.
Impact: Improved capabilities for specimen or sample collection, preservation, inactivation, and transportation will result in faster laboratory testing, reduce public health costs, and improve testing capabilities in low complexity settings. The impact of this initiative is broadly applicable to many CDC’s “Winnable Battles” including HIV, food safety, obesity, achieving and sustaining global immunization goals, and eliminating lymphatic filariasis in the Americas. In addition, this improved capability will support core CDC surveillance programs such as the National Health and Nutrition Examination Survey, National Health Interview Survey, and the National HIV Behavioral Surveillance System. New technologies resulting from this project have commercialization potential within the growing home health testing market, global diagnostics, and traditional laboratory testing venues.
