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Biosafety

The European Reference Laboratory Network for Human Influenza (ERLI-Net) conforms to EC Directive 2000/54/EC and the World Health Organization (WHO) recommendations for human and avian influenza viruses regarding laboratory containment procedures. Human influenza viruses are handled and cultured under biosafety level 2 (BSL-2) conditions while highly pathogenic avian influenza viruses (HPAI) have to be handled and cultured under BSL-3 conditions. Since not all ERLI-Net members have BSL-3 facilities and since detection of HPAI by nucleic acid amplification techniques (NAT) may be done under BSL-2 conditions, it is the aim of ERLI-Net to equip all member laboratories for HPAI detection by NAT.
 
ERLI-Net also conforms to EC Directive 2008/68/EC international treaties1, IATA regulations2, and WHO recommendations for human and avian influenza viruses regarding requirements for transport of infectious material. Diagnostic specimens suspected of containing human influenza virus or HPAI fall under category B infectious substances (UN 3373) and are transported by ERLI-Net using packaging instructions (PI) 650, although the more stringent PI 620 for category A substances may be used. Cultures of certain human pandemic influenza and HPAI fall under category A infectious substances (UN 2814) and are transported by ERLI-Net using PI 620.
 
Influenza A(H1N1)pdm09 virus is widespread worldwide and considered a currently circulating Influenza A seasonal virus. WHO guidance states that diagnostic laboratory work on clinical specimens from suspected cases of infection should be conducted in BSL-2 containment conditions with the use of appropriate laboratory safety controls and personal protective equipment (PPE).

However, in the guidance document 'Guidance on regulations for the transport of infectious substances 2021-2022' WHO advises:"Final responsibility for the identification and implementation of appropriate containment measures for handling and storage of influenza A(H1N1)pdm09 virus lies with individual countries and facilities. Accordingly, needs may vary from country to country, and decisions should be taken in light of currently available knowledge and context. The global biosafety community is moving away from recommending the use of strict biosafety level (BSL) definitions (CWA15793 Laboratory Biorisk Management, 2008). Accordingly, WHO will only provide more detailed containment guidance when cautious approaches will be warranted."

As with any influenza virus isolation procedures, laboratories should assess the risks and potential consequences of virus re-assortment events in vitro, and adopt all appropriate measures to prevent such occurrences.

References

1) European Agreement concerning the International Carriage of Dangerous Goods by Road (ADR), Regulations concerning the International Carriage of Dangerous Goods by Rail (RID), European Agreement concerning the International Carriage of Dangerous Goods by Inland Waterways (ADN), International Maritime Dangerous Goods (IMDG) Code
 
2) ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air, IATA Dangerous Goods Regulations (DGR) and Packing Instructions