We recently released a new version (v2) of 3 of our assays that detect Salmonella.
We have updated and replaced 3 of our PathoSEEK® Detection Assays:
- 420101 PathoSEEK Salmonella Detection Assay (200 rxn) has been replaced with 420118 PathoSEEK Salmonella Detection Assay (200 rxn) v2
- 420113 PathoSEEK Salmonella & E.Coli Multiplex Detection Assay (200 rxn) has been replaced with 420119 PathoSEEK Salmonella & E.Coli Multiplex Detection Assay (200 rxn) v2
- 420122 PathoSEEK Salmonella & STEC E.Coli Multiplex Detection Assay (200 rxn) has been replaced with 420120 PathoSEEK Salmonella & STEC E.Coli Multiplex Detection Assay (200 rxn) v2
Why are we releasing a version 2?
When the Salmonella assays were first developed by Medicinal Genomics, the guidance or regulations available at the time called for Salmonella enterica. The inclusion criteria for AOAC requires 100 different serotypes to be surveyed. In the process of surveying this larger diversity, we have found a few strains that escape our current primer sets. To remain backwards compatible with our historical primer sets we have opted to add additional primers to our primer/probe mix as opposed to altering the historical primers. The additional primer set added targets the InvA D- loci which has been tested against over 100 different serovars by the FDA. We are still working to acquire 100 different isolates to reproduce this work in hemp matrix but believe these new primers are the most vetted primers in the industry. We have tested these primers in hemp background and found they adequately detect the serovars missed by our previous primers. In conclusion, all 3 Salmonella V2 assays now also detects the following subspecies:
- Salmonella bongori
- Salmonella arizonae
We have also updated our Manufacturers Validation Document in the following places to reflect these changes. See the most up to date Validation Document here: https://www.medicinalgenomics.com/validation-documents/
What about the version 1 assays?
We will have some of the v1 assays available on the web store until inventory of these are exhausted. We will not be ordering more of the v1 assays. As stated above, we have not changed anything from v1 to v2, we've only added additional primers to cover more species. Extensive re-validations should not be necessary. As always, please consult your regulatory agency to determine what level of re-validation, if any, is necessary.
Has the positive control changed?
NO, the positive control has not been altered in any way.