Genetic Detection Limited

Case Studies

Food

A fungal contamination problem occurred in a production factory. Identification methods used in the QC laboratory were not sensitive enough to identify the fungi to the species level. We used 18S ITS sequencing to identify the fungi to the species level and in parallel carried out morphological examinations. We confirmed that differences seen microscopically were sexual and asexual forms of the same species.

Pharmaceutical

A sterility test positive was found in a production line. We carried out genetic analysis using 16S sequencing technology and identified the organism to be Micrococcus luteus. Further analysis of all M. luteus isolates found on a particular day, by Pulse Field Gel Electrophoresis (strain level identification), traced the cause of the sterility test positive to a bacterial isolate on the glove of the tester.

Pharmaceutical

A media run positive occurred in a production line. In the production plant, the liquid culture showed growth but on plating no growth occurred. We received the liquid culture and plates and likewise we could not get growth on the plates. However, using a number of molecular methods including PCR and creating a clone library we were able to identify 5 different species of organisms from the liquid. Using this method we identified viable and non-viable organisms in the media run positive and were able to identify species organisms to the strain level.