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

A.3
A.3 Study design
large-size stores already in operation (REMP store at Pfizer, Groton, Connecticut, USA;
TAP store at UK Biobank in Manchester, UK). A European call for tenders will be launched
for final selection.
For storage in the automated repository (and beyond), 0.2-ml Micronic tubes equipped with
a 2D barcode and stable in the vapor phase of liquid nitrogen will be used.
Manual centrally operating archive at HMGU (–180°C)
Half (three-sixths) of the sample aliquots will be stored in a manually accessible working
archive in the vapor phase of liquid nitrogen tanks (per participant: 15x serum, 24x plasma,
3x erythrocytes, and 6x urine), located adjacent to the automated repository.
The selection of one out of two liquid nitrogen storage tank systems will be made on the
basis of a call for tenders in Europe.
Once a participant has proven to be of special interest for scientific research, i.e., due to
disease occurrence, two-sixths of his/her aliquots will additionally be transferred to the automated
biorepository, thus, in the long term, enriching the biorepository with so-called VIM.
Cryopreserved viable cells will be stored exclusively in the vapor phase in liquid nitrogen
tanks.
Manual local back-up archives (–180°C)
One third of the blood and urine samples will be stored in local centers, preferably in one
center per cluster participating in the National Cohort. The aliquots will be stored in the vapor
phase of liquid nitrogen tanks (per participant: 10x serum, 16x plasma, 2x erythrocytes,
and 4x urine). It forms a back-up storage system for the central biobank.
Number of stored aliquots
The total number of aliquots stored centrally will amount to about 20 million over the whole
course of the cohort study, including samples obtained at recruitment, at short-term reassessment
(for calibration purposes), and at reassessment of all participants after 5 years.
Another ~8 million aliquots will be stored in local back-up archives.
Laboratory information management system
All steps from blood extraction until storage and later retrieval of aliquots will be controlled
by a laboratory information management system (LIMS) registering each single aliquot by a
unique defined barcode and monitoring and recording each individual step in the laboratory
processing and in the storage when linked to the store's own inventory and tracking system.
Currently, the four companies LabVantage, LisaLIMS, StarLIMS, and Lablynx satisfy these
requirements. A call for tenders in Europe will be launched to select the LIMS provider/
system.
The LIMS system will be integrated into the overall data management system of the National
Cohort.
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