This test is performed on sterility positive samples, bioburden plates, microorganisms on agar plates or tubes containing agar or liquid media.
Test systems available are:
- MicroSeq® library and an Applied Biosystems/Hitachi 3500 Genetic Analyzer
- Vitek® 2 Compact
- Classical Mold Identification (Genus only)
Genetic identification testing uses DNA instead of traditional biochemical reactions, resulting in more reliable results. It entails collecting the DNA from an organism, creating many copies of a specific sequence (16 S Ribosomal DNA for bacteria and the D2 region for fungi), and then sequencing and comparing it to a known MicroSEQ® library.
Nelson Laboratories recommends performing genetic identification routinely, giving manufacturers more confidence in the identification process and expediting any investigation after a failure. In addition to increased efficiency, the method also offers these advantages to manufacturers:
- Genetic testing gives more reliable, precise and faster results.
- Genetic testing is independent of growth conditions and environmental factors; dead or injured organisms can be identified.
- Genetic testing can be bundled with other tests for a streamlined, efficient way to expedite the testing process.
“I have always been pleased with the service that I have received from Nelson Labs. It was especially helpful when Dr. Nelson was willing to visit our facility last year to review, evaluate, and give us some feedback on our RO/DI water system.”
Russell , Manufacturing Engineer , Medical Device Company
Organism Identification and Baseline Testing
Genetic identifications require a pure culture. Please send in isolate microorganisms if possible, otherwise we will need to re-streak for isolation for a possible additional fee. Most broths or liquid samples will be re-streaked for purity prior to testing. A gram stain will be done as part of checking for purity.
Non-viable organisms in liquid will be centrifuged into a pellet prior to testing, but purity cannot be ensured.