Silk-Based Biospecimen Stabilization for Exposure Assessment Project Summary/Abstract There is a critical need for a stabilization platform that can preserve biospecimen integrity, completely free of cold storage requirements. Such a technology would allow researchers, clinicians, government personnel and consumers to conduct biomonitoring in field conditions (i.e. without requiring visits to the outpatient lab). Our long-term goal is to develop a platform technology that maximizes the stability of a wide range of biospecimens in a novel silk protein matrix and that seamlessly integrates with downstream analytics. The objective of the current proposal is to build a novel collection device capable of capturing known volumes of specimen, integrating with the silk matrix stabilizer investigated in our Phase I program, and allowing for immediate storage and shipment via the use of desiccant drying. Our central hypothesis is that a new collection device can be designed in order to overcome both practical design-oriented and fundamental technological limitations of current sample collection options. Our hypothesis has been formulated based on our recent published and unpublished data using silk to stabilize a range of serum/plasma proteins and new insights into processing techniques that allow silk to be stored and shipped for extended durations at elevated temperatures. Therefore, in the first aim we will develop a novel collection device to accommodate the new silk feature. As a second aim, a 50-person cohort will be recruited for venous blood, capillary blood, and saliva samples, to be aliquoted and stored in the silk system, dried paper, or as liquid aliquots subject to various processing delays to simulate remote transportation use cases. In the third aim, two hundred subjects taken from an existing Indian cohort will be evaluated for hazard exposure (Vaxess) and plasma levels of liver, thyroid, and cardiovascular disease biomarkers (Agada medical). The expected outcomes would be a broader fundamental basis behind silk stabilization and new methods to translate these findings towards biospecimen recovery and storage as they pertain to biomonitoring. The rationale for the proposed research is that, once collection devices are validated, they can be used in a variety of external partnership settings. Success with the planned approach can positively impact many areas of need in the field of diagnostics and epidemiology. These needs include alternative approaches at solid biospecimen stabilization, and translation/validation of analytical techniques important for hazard exposures. Furthermore, by offering methods to interface with finger-prick volumes (i.e. less invasive quantities) of whole blood, a silk-based stabilization system could significantly reduce financial burdens associated with the outpatient clinic, and in turn increase accessibility.
The proposed research is relevant to public health because it will enable transformative approaches at dried biospecimen transport to laboratory facilities, improving testing accuracy and obviating the need for patient travel. With more widespread adoption, the entire healthcare system and epidemiological biomonitoring programs will see reduced costs and improved accuracy of testing due to improved sample integrity.
