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Harmonization of Biobank Education for Biobank Technicians: Identification of Learning Objectives
(2021)
: The quality of biospecimens stored in a biobank depends tremendously on the technical
personnel responsible for processing, storage, and release of biospecimens. Adequate training of
these biobank employees would allow harmonization of correct sample handling and thus ensure a
high and comparable quality of samples across biobank locations. However, in Germany there are no
specific training opportunities for technical biobank staff. To understand the educational needs of
the technical personnel a web-based survey was sent to all national biobanks via established e-mail
registers. In total, 79 biobank employees completed the survey, including 43 technicians. The majority
of the participating technical personnel stated that they had worked in a biobank for less than three
years and had never participated in an advanced training. Three-quarters of the technicians indicated
that they were not able to understand English content instantly. Based on these results and the results
of a workshop with 16 biobank technicians, 41 learning objectives were formulated. These learning
objectives can be used as a basis for advanced training programs for technical personnel in biobanks.
Setting up courses based on the identified learning objectives for this group of biobank staff could
contribute to harmonization and sustainability of biospecimen quality.
In 2017, in the Polish-German transborder area of West Pomerania, Mecklenburg-Western Pomerania, and Brandenburg, in collaboration with two centers in Warsaw, a partnership in the field of newborn screening (NBS) for severe primary immunodeficiency diseases (PID), mainly severe combined immunodeficiency (SCID), was initiated. SCID, but also some other severe PID, is a group of disorders characterized by the absence of T and/or B and NK cells. Affected infants are susceptible to life-threatening infections, but early detection gives a chance for effective treatment. The prevalence of SCID in the Polish and German populations is unknown but can be comparable to other countries (1:50,000–100,000). SCID NBS tests are based on real-time polymerase chain reaction (qPCR) and the measurement of a number of T cell receptor excision circles (TREC), kappa-deleting recombination excision circles (KREC), and beta-actin (ACTB) as a quality marker of DNA. This method can also be effective in NBS for other severe PID with T- and/or B-cell lymphopenia, including combined immunodeficiency (CID) or agammaglobulinemia. During the 14 months of collaboration, 44,287 newborns were screened according to the ImmunoIVD protocol. Within 65 positive samples, seven were classified to immediate recall and 58 requested a second sample. Examination of the 58 second samples resulted in recalling one newborn. Confirmatory tests included immunophenotyping of lymphocyte subsets with extension to TCR repertoire, lymphoproliferation tests, radiosensitivity tests, maternal engraftment assays, and molecular tests. Final diagnosis included: one case of T-BlowNK+ SCID, one case of atypical Tlow BlowNK+ CID, one case of autosomal recessive agammaglobulinemia, and one case of Nijmegen breakage syndrome. Among four other positive results, three infants presented with T- and/or B-cell lymphopenia due to either the mother's immunosuppression, prematurity, or unknown reasons, which resolved or almost normalized in the first months of life. One newborn was classified as truly false positive. The overall positive predictive value (PPV) for the diagnosis of severe PID was 50.0%. This is the first population screening study that allowed identification of newborns with T and/or B immunodeficiency in Central and Eastern Europe.