A randomised controlled pilot study to compare filtration factor of a novel non-fit-tested high-efficiency particulate air (HEPA) filtering facemask with a fit-tested N95 mask.

Use of a fit-tested N95 or FFP2 mask is recommended to protect against transmission of airborne pathogens. This poses considerable logistic problems when preparing for, or dealing with, an epidemic. Some of these problems might be overcome by use of a compact reusable high-efficiency particulate air filtering mask that can be cut to size. We carried out a randomised controlled cross-over study to compare the efficacy of such a mask (Totobobo, Dream Lab One Pte Ltd, Singapore) with fit-tested N95 masks (1860 or 1860s or 1862; 3M, St Paul, MN, USA) in 22 healthy volunteers. The median (interquartile range) reduction in airborne particle counts was significantly higher [193-fold (145-200)] for N95 masks than for Totobobo masks [135-fold (83-184)] (P<0.05). There was no statistically significant difference between the proportion of subjects achieving a reduction of > or =100-fold between N95 (19/22) and Totobobo (16/22) masks. We conclude that use of the Totobobo mask without fit testing cannot be recommended, but its performance is sufficiently promising to warrant further investigation.