Scientific Concept of the National Cohort (status ... - Nationale Kohorte

A.3
A.3 Study design
study. For example, PAXgene and Tempus tubes will be compared for quantitative RNA
recovery and RNA quality. Both absolute cell recovery and representation of the various
mononuclear cell fractions using Becton Dickinson 'CPT' tubes will be assessed in comparison
to conventional Ficoll-Hypaque gradient centrifugation of ACD blood.
Urine
� Spot urine will be collected in 100-ml collection tubes (without additives). After centrifugation,
the supernatant will be cooled in ice water, and aliquots will be prepared
by using the liquid handling platform.
� The pellet and five 10-ml aliquots will be stored separately; a final decision regarding
this, however, is pending.
Saliva
� Saliva will be collected using SaliCap collection tubes (IBL International) with the aim
of obtaining a final saliva volume of 2 ml. Two aliquots of saliva will be stored.
Stool
� Study participants will be provided with the stool collection tube (and supplemental
material) beforehand, along with a description of how and when the stool sample will
be selected and how the tube will be handled before transport to the study center (at
visit). Each participant will be asked for one stool sample, at best from stool produced
in the morning of the day of the study center visit. Two aliquots of stool will be stored.
SOPs for collection and (minimum) processing of stool samples compatible with the constraints
of field work in epidemiologic studies need to be definitively elaborated, and testing
of sample quality necessary for high-throughput sequencing of microbial DNA and RNA will
be conducted in the frame of a feasbility study.
Nasal swabs
� A trained study nurse will take a nasal swab using flocked nylon fiber sterile applicators
(Copan Italia, Brescia, Italy). The tip of the swab will be frozen at the study center
and shipped frozen to the central biobank, where it will be stored at –80 o C. The biobanked
swabs will be analyzed with culture-independent methods only.
Elaboration of SOPs for standardized collection, comparison between different types of
swabs regarding their ease of collection, and their use in microbial/virological studies will be
tested in the feasibility study.
A.3.5.4 Concept for transport, storage, and retrieval of biomaterials
Transfer of biosamples to central and local storage centers
Transportation will be required for the aliquots of serum, plasma, urine, blood, and the saliva,
nasal swabs, and stool that are prepared ready-for-use in the local study centers. They
will be transferred on dry ice to either local or central storage facilities. The biomaterials to
be processed in the central laboratory must be transferred at ambient temperature (viable
cells) or at 4°C. Professional transportation companies will be hired at defined intervals to
transport the materials to the central and local biobanks.
Overview of storage of biomaterials
The collected biomaterials will be stored in three different ways:
� Automated central biorepository at the helmholtz zentrum muenchen (hmGu)
in Munich/Neuherberg (–80°C)
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