On 16 April 2020, representatives from the German Biobank Node (GBN) and German Biobank Alliance (GBA) met with biosafety experts to discuss the biobanking of SARS-CoV-2 samples. GBN had already compiled information on how to work with such samples (see here) based on the resolution of the Committee on Biological Agents (ABAS) dated 27 March 2020 on the preliminary classification of the SARS-CoV-2 virus and the associated recommendations on activities (laboratory diagnostics). However, the ABAS resolution does not contain specific recommendations for biobanking activities. Hence GBN and GBA representatives consulted a panel of experts regarding this. The experts emphasised that biobanks should not treat samples from COVID-19 patients any differently to comparable potentially infectious samples (TRBA 100 4.4.1). The risk assessment is decisive to the procedure at the biobank. The team of experts recommended that SARS-CoV-2 samples in which the virus is detectable are handled in a Class II biosafety cabinet.
Blood samples
In light of the low viral load, it is not necessary to wear a protective mask when working with blood samples – as long as the samples are processed in the biosafety cabinet in an orderly manner by trained personnel. If biobank processes are wholly or partially automated (e.g. a pipetting robot is used), the manufacturer specifications on infection protection must of course be complied with. The need for additional protective equipment must be based on the risk assessment.
Respiratory, urine and stool samples
Greater caution must be exercised with respiratory samples. Work must take place in a Class II biosafety cabinet; it is also advisable to wear a respirator (FFP-2 mask) and protective goggles. Urine and stool samples are to be treated like blood samples: according to the current data, no virus genomes are detectable in urine samples. According to the majority of the publications currently available, virus genomes are frequently found in stool samples, but not in an infectious form. However, faecal-oral transmission cannot be ruled out entirely at this point (Pan X et al. 2020).
Provision of samples
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 § 52 IfSG, material containing pathogens may only be supplied to persons authorised to handle these samples or working under the supervision of an authorised person. The experts advised biobanks to 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 will add a corresponding form to its QM manual soon.
Consent forms: potentially infectious?
The experts consider the risk of consent forms signed by COVID-19 patients being infectious for a long time to be extremely low. No “special procedure” is required here, however the processes prescribed for comparable samples should be followed.
More information and links:
- Information on working with SARS-CoV-2 samples
- Resolution of the Committee on Biological Agents (ABAS) dated 27 March 2020
- Technical Rules for Biological Agents (TRBA) 100
- Asymptomatic cases in a family cluster with SARS-CoV-2 infection. Pan X, Chen D, Xia Y, Wu X, Li T, Ou X, Zhou L, Liu J. 2020. Lancet Infect Dis 20(4):410–1.
