Coronavirus Handling & Biosafety Levels
For the last few days, Coronavirus (SARS-CoV-2) and the disease it causes (COVID-19) is what we are all talking about.
The importance of testing and prompt diagnosis has become evident to all. But what is involved in handling, processing, storing, and disposing the test specimen/samples or research material for drug discovery & development?
Whilst very little is known about this new form of coronavirus, the UK government has recently published interim guidance specifically for clinical diagnostic lab practice in England, accessible below.
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.
With our 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 include the principles of biosafety, listed below:
1. Laboratory Practices and Technique
2. Safety Equipment (Primary Barriers and Personal Protective Equipment)
3. 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) provide the following guidance for classification into one of four Hazard Groups (HGs).
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 account2 –
(a) the nature of the activity
(b) the minimum containment level
(c) the risk assessment; and
(d) the nature of the biological agent concerned.
With some exceptions and guidance by COSHH2.
Based on the above, one would expect SARS-CoV-2 to be HG4, however 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”,
1. GOV.UK: COVID-19: safe handling and processing for samples in laboratories
2. HSE: The Control of Substances Hazardous to Health Regulations 2002. Approved Code of Practice and guidance
Dr Manisha Kulkarni
Head of Science & Technology