Genetic Identification of Microorganisms Now Offered by Nelson Labs

Nelson Laboratories is now conducting genetic identification (ID) testing in-house using new equipment that performs the test more quickly, more efficiently and more reliably than other identification methods.

Genetic ID testing uses DNA instead of traditional biochemical reactions, creating more reliable results. This will help to resolve questions about organisms found in testing and investigations, enabling manufacturers to take their products to market faster. Nelson´s genetic ID testing equipment is the newest product available in the industry and looks at 16 S Ribosomal DNA for bacteria and the D2 region for fungi.

'We believe the medical device industry is moving towards making genetic ID the standard for identification testing,' said Bryan Brezoff, Nelson Labs ID section leader. 'Proactively moving on that notion, we already recommend performing the test routinely, giving manufacturers more confidence in the identification process and expediting any investigation after a failure.'

In addition to the increasing efficiency, pricing for the new system is the same as current testing and offers the following advantages to manufacturers:

• Genetic IDs give more reliable, precise and faster results


• Genetic ID testing is independent of growth conditions and environmental factors; dead or injured organisms can be identified


• Genetic IDs can be bundled with other tests for a streamlined, efficient way to expedite the testing process.

Medical device manufacturers face a myriad of challenges trying to stay on top of current regulations and standards issued for testing. Identifying specific microbes can help determine where in the process the failure occurred. Genetic ID testing provides a higher degree of assurance that offending microbes are the organisms named by the identification system.

While most genetic ID testing is performed after a sterility, bioburden or environmental monitoring test failure, the industry is moving towards proactively conducting genetic ID testing with other required tests. In addition to providing genetic ID testing, Nelson Labs is a leading provider of full life-cycle microbiology testing services for the medical device, pharmaceutical, tissue, and natural product industries.