Nucleic Acid Based Sterility Testing

Nucleic Acid Based Sterility Testing (NAT-testing) is a cutting edge technnology for time, sensitivity and volume critical applications that cannot wait for culture based sterility testing as described EP 2.6.1 or 2.6.27. Microsart ATMP Bacteria is a recent development based on years of experience with the Onar® Bacteria Kit coventional PCR kit. It is an ultra-fast and sensitive qPCR in combination with a special DNA-free broad range bacterial extraction system designed and tested for detection of bacterial contamination in less then 24 hours in cell cultures, cell culture derived biologicals and cell culture media.

qPCR allows rapid and sensitive detection of bacterial contamination in biological samples. Amongst others, the following types of bacteria will be detected by targeting a highly conserved fragment of the 16S rRNA region: Pseudomonas, Actinomyces, Escherichia, Serratia, Porphyromonas, Fusobacteria, Staphylococcus, Streptococcus, Lactobacillus, Micrococcus, Bacillus, Klebsiella, Salmonella, Enterococcus, Mycobacterium, Legionella, Prevotella, Peptostreptococcus.

Fungi-testing is currently in development and will be made available in our laboratory in the second half of 2019 complementing bacterial based sterility testing. Together, both tests will be able to replace culture based testing for certain applications. Please contact us for further information e.g. on assay validation and sample requirements.