Manual of Standard Operating Procedures

Purpose

The purpose of this protocol is to facilitate a streamlined process for biospecimen collection, storage, shipping, and processing. By following these protocols, biospecimens will be collected and handled uniformly, ensuring that data acquired from prospective uses are as comparable as possible, regardless of the collection site.

Scope

This manual is broadly broken into four main sections: Collection Kit Overview, Biospecimen Collection, Shipping Instructions, and Quality Control. Biospecimen collection kits are assembled in the INCLUDE DS-Biorepository central lab, located at the University of Colorado Anschutz Medical Campus, and shipped to various collection sites. Using these kits and following the protocols outlined in the Biospecimen Collection section, the collection sites will at a minimum, collect and store tongue swabs, cells for downstream DNA isolation, cells stabilized for RNA isolation, and plasma. In addition to the minimum, these protocols will facilitate the collection of cryopreserved buffy coat, red blood cells, and whole blood fixed for immunophenotyping using Cytometry by time of flight (CyTOF®). Samples will be batch-shipped once a predetermined threshold of 4 participants (U.S. Sites) or 10 participants (international sites) have been collected, or 3 months have passed since the last shipment.

Required Materials

Below is a list of the required materials for biospecimen collection, storage, and return shipment to the central biorepository. Once received by the central lab, these samples will be stored for prospective research use. Many of these materials are provided by the DS-Biorepository central lab as part of the pre-assembled kits. Materials provided in these kits, as well as materials and equipment required but not supplied, are detailed below and in their respective portions of the Biospecimen Collection section.