Working with SARS-CoV-2 samples
Pursuant to Section 52 of the German act on the prevention and control of infectious diseases (Infektionsschutzgesetz, IfSG), material containing pathogens may only be supplied to persons authorised to handle these or working under the supervision of an authorised person.
Requirements according to IfSG
The German act on the prevention and control of infectious diseases (Infektionsschutzgesetz, IfSG) regulates the legal obligations to prevent and combat infectious diseases in humans. Pursuant to Section 52 IfSG, material containing pathogens may only be supplied to persons authorised to handle these or working under the supervision of an authorised person. Biobanks must therefore obtain written confirmation from the respective recipients during the supply of SARS-CoV-2 samples that they or their facility are able to handle pathogens in risk group 3 correctly in accordance with IfSG or the German ordinance on biological substances (Biostoffverordnung, BioStoffV). GBN has added a corresponding form to its QM Manual. The QM Manual is available on Zenodo via open access.
In the following presentation, Christiane Hartfeldt (QM Core Team, GBN) presents the application of GBN’s QM Manual during the handling of SARS-CoV-2 samples at biobanks. She delivered this presentation during a GBN webinar on handling infectious samples held on 29 April 2020. See here for the full webinar documentation.
Packaging and shipment
According to the Robert Koch Institute (RKI), samples taken from suspected cases to detect SARS-CoV-2 are to be classified as Category B biological substances as per UN 3373 and packed in accordance with Packing Instruction P650. Shipments must be refrigerated wherever possible and the packaging must consist of three components, namely primary, secondary and outer packaging, which is often commercially available in the following forms:
- Primary packaging = sample tube (e.g. swab tube or vacutainer)
- Secondary packaging = protective vessel (liquid-tight screwed plastic tube with absorbent material inside)
- Outer packaging = box-shaped packaging
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