The WHO Laboratory Biosafety Manual (LBM) has been in broad use at all levels of clinical and public health laboratories, and other biomedical sectors, serving as a de facto global standard that presents best practices and provides the foundation upon which national policy instruments are built since the release of its first edition in 1983.
The thoroughly revised 4th edition, LBM4, that consists of core document and seven subject-specific monographs, was developed over five years through systematic appraisal and a consensus process with diverse stakeholders and is now released.
Life science technologies have evolved substantially since publication of the LBM third edition in 2004, and so have risk profiles and biosafety. For instance, polymerase chain reaction (PCR) and other molecular methods are now in broad use, having replaced far riskier culture of the biological agents as the primary diagnostic test of choice.
With particular emphasis on evidence, local biological risk assessment and personnel competence, the LBM4 presents a novel approach that allows each facility to take a feasible and most effective combination of risk control measures. This flexibility, as opposed to conventional equation of pathogen risk group and biosafety level, enables optimised usage of limited resources.
The whole context of the work being planned, such as procedures and titres, should be factored in determining the actual risk and control measures, not just relying on the inherent characteristics of the pathogens. COVID-19 presents a good example of the risk-based approach, where rapid diagnostic testings, conventional PCR and virus isolation are widely performed in totally different biocontainment stages, ranging from non-laboratory environments to heightened control measures proportionate to the risk of each assay.
LBM4 provides both overarching theory and practical guidance, including risk assessment. This technology-neutral approach will help attain much desired equitable, adequate and sustainable access to necessary laboratory services and life science research across all countries, without compromising safety.
- LBM4 core document
- Subject-specific monographs
Resources (position paper)
Further information: Safeguarding biosafety and biosecurity in laboratories