Neogen's ANSR for Listeria has been NF certified in accordance with the current and stringent criteria of a NF Validation study carried out according to the EN ISO 16140 part 2 standard for food and environmental samples.
This new validation (NF Validation by AFNOR certification NEO 35/03-01/16) follows the kit's initial approval by AOAC International. ANSR for Listeria is a molecular isothermal automated method that provides genetic level discrimination of specified targets at 1 cfu/25g of sample in just 18 minutes, post enrichment and lysis steps.
"The NF validation of ANSR for Listeria will allow Neogen access to a number of European markets, and beyond, where the use of the test requires an accreditation study carried out according to the AFNOR standard," said Neogen's Steve Chambers. "ANSR is a fast DNA-definitive pathogen assay with results in under 23 hours, including enrichment, for Listeria. Compared to the time other methods take to produce DNA-level results, that can mean a huge difference in a laboratory's workflow, and the operations of a food producer."
In the NF study, ANSR for Listeria was validated with a wet pooling protocol that permits running one molecular test for up to 10 samples saving reagents, handling and time for the laboratory. Enriched samples from different categories can be mixed, if desired (e.g., dairy products with environmental samples). The validation study was conducted according to ISO 16140 part 2: FDIS 2015 protocol on a broad range of 449 food and environmental samples. All samples were analyzed in comparison to the EN ISO 11290-1:2004 reference method, and the study showed that ANSR for Listeria is more sensitive than the standard.
Neogen is currently pursuing a similar validation of its ANSR for Listeria monocytogenes rapid molecular test system, and was certified by AFNOR validation for its ANSR for Salmonella test in 2013.
All of Neogen's ANSR tests, which include kits for Listeria spp., Listeria monocytogenes, Salmonella and E. coli O157:H7, have been granted PTM(SM) certification by the AOAC Research Institute. The ANSR system uses an innovative isothermal DNA amplification process and fluorescent molecular beacon technology for detection of the target pathogen.
Neogen Europe Ltd., the European subsidiary of Neogen Corporation (NASDAQ: NEOG), is a biotechnology business dedicated to the development and marketing of solutions for food and animal safety. The company's diagnostic test kits focus on the quality and safety of food and agricultural products, from the time the seed goes into the ground, right through the chain to the safety of fully processed food products. Neogen Europe was awarded the Queens Award for Enterprise for international trade and development, one of the highest awards bestowed on a UK company.
