The contamination monitoring toolbox: Best practices for molecular microbiology testing

Abstract

Assays that utilize nucleic acid amplification are prone to contamination from a variety of sources, including both target organisms and amplicon. Implementing effective systems for contamination monitoring as well as laboratory best practices are essential to any quality management system for molecular microbiology testing. A comprehensive contamination monitoring toolbox will be introduced here that includes guidance for environment swabbing, positivity rate monitoring, use of process controls, and monitoring complaints. As prevention of contamination is preferable, best practices for laboratory design, workflow, and personnel training will also be discussed. Lastly, a suggested plan for managing a contamination event will be proposed. The laboratory director should carefully assess the specific risks associated with testing performed in the laboratory and create a written plan for contamination monitoring, prevention, and management of contamination events.