Coronavirus (SARS-CoV-2) and the disease it causes (COVID-19) is what we are all talking about at the moment. The importance of testing and prompt diagnosis has now become abundently evident to all. But what is involved in handling, processing, storing, and disposing the test specimen/samples or research material for drug development?
Little is still known about this new form of coronavirus, the UK government has recently published an interim guidance specific for clinical diagnostic lab practice for England, accessible here but it is important to note that this guidance is not for virus research laboratories.
As this is a novel virus, the ACDP (Advisory Committee on Harmful Pathogens) has agreed on a provisional classification of SARS-CoV-2 as a Hazard Group 3 (HG3) pathogen based on the current information1 and other coronavirus family agents e.g. SARS & MERS viruses.
As an UKSAPA member ad with Bulb Laboratories background and capability in designing and delivering R&D and diagnostic laboratories, it would be prudent to provide some basics on various hazard group classification, biosafety levels and containment required for the safe handling of various pathogens.
Some key considerations during design phase of the facility includes the principles of biosafety, as below:
- Laboratory Practices and Technique
- Safety Equipment (Primary Barriers and Personal Protective Equipment)
- Facility Design and Construction (Secondary Barriers)
At Bulb, we try to understand clients’ research area, lab practices, techniques and primary barriers they may use while designing secondary barriers through proper engineering controls.
For labs handling biological agents, COSHH (Control of Substances Hazardous to Health) provides following guidance for classification into one of four Hazard Groups (HGs).
Hazard Group 1: unlikely to cause human disease.
Hazard Group 2: can cause human disease and may be hazardous to employees.
Hazard Group 3: can cause severe human disease and may be a serious hazard to employees; it may spread to the community, but there is usually effective prophylaxis or treatment available.
Hazard Group 4: causes severe human disease and is a serious hazard to employees; it is likely to spread to the community and there is usually no effective prophylaxis or treatment available
Employers engaged in handling biological agents; HG1-4 shall ensure adequate control measures are undertaken to control exposure to employees by combination of containment measures taking into account (see note 2 below)
(a) the nature of the activity
(b) the minimum containment level
(c) the risk assessment; and
(d) the nature of the biological agent concerned.
Generally,
Containment level 1 (Bio Safety Level 1, BSL1) for activities which involve working with a Group 1 biological agent, HG1.
Containment level 2 (Bio Safety Level 2, BSL2) for activities which involve working with a Group 2 biological agent, HG2.
Containment level 3 (Bio Safety Level 3, BSL3) for activities which involve working with a Group 3 biological agent, HG3.
Containment level 4 (Bio Safety Level 4, BSL4) for activities which involve working with a Group 4 biological agent, HG4.
With some exceptions and guidance by COSHH2.
Although based on the above, one would expect SARS-CoV-2 to be HG4 but as mentioned earlier in the article, as this is a novel virus, the ACDP has agreed on a provisional classification of SARS-CoV-2 as a Hazard Group 3 (HG3) pathogen based on the current information1 and other coronavirus family agents e.g. SARS & MERS. This might change in the future as the knowledge of the virus develops.
For now, guidance for the clinical diagnostic labs is as below.
“The UK govt has advised (as of on 20th March 2020) that samples for confirmation of known or presumptive positives must be processed at full containment level (CL3).
However, in light of the exceptional circumstances posed by SARS-CoV-2 and the potential impact on the diagnostic sector, a risk-based proportionate approach has been adopted in agreement with ACDP and HSE where certain laboratory activities can be undertaken within a MSC at containment level 2 (CL2)1”,
References:
- GOV.UK: COVID-19: safe handling and processing for samples in laboratories
- HSE: The Control of Substances Hazardous to Health Regulations 2002. Approved Code of Practice and guidance
Dr Manisha Kulkarni
Head of Science & Technology
Bulb Laboratories
UKSPA Articles are a place for thought-provoking views and debate. The views are those of the author and not necessarily shared by UKSPA.
