According to the DCC labs must repeat inclusivity and exclusivity tests for the target Aspergillus species. Two replicates at the different inoculation levels are also applicable in this validation.
Medicinal Genomics currently has two Aspergillus Multiplex qPCR assays on the market, one that detects all 4 Aspergillus species on the FAM channel (PathoSEEK® 2-Color Aspergillus Multiplex) and the other which specifies each species on a different channel (PathoSEEK® 5-Color Aspergillus Multiplex). Both Aspergillus Multiplex assays use the same primers and probes to target the four pathogenic Apergillus species (A. flavus, A. fumigatus, A. niger, and A. terreus).
Medicinal Genomics asked the DCC what validation needs to be performed by labs that are currently validated on the 2-color Aspergillus Multiplex assay but want to switch to the newer 5-color version. While the DCC response was not very clear, we determined that a lab must repeat inclusivity and exclusivity tests for the target Aspergillus species. Two replicates at the different inoculation levels are also applicable in this validation.
Thank you for contacting the Bureau of Cannabis Control (Bureau). Other licensed testing laboratories have successfully demonstrated their capability with a modified method validation report and experiment process.
The laboratory will have to demonstrate inclusivity and exclusivity for the target Aspergillus species. BCC regulations require at least five target organisms. Therefore, laboratories are encouraged to explore different strains, subspecies, serovars, etc. Replicate requirements and inoculum level requirements are also applicable in these studies. We encourage you to review 16 CCR section 5713 for additional details.
We understand this to mean labs who are upgrading from the PathoSEEK® 2-Color Aspergillus Multiplex to the PathoSEEK® 5-Color Aspergillus Multiplex must show inclusivity for the four Aspergillus species of interest (A. flavus, A. fumigatus, A. niger, and A. terreus) and exclusivity of one Aspergillus or fungus species. There are no strains, subspecies, or serovars for Aspergillus, so this language in the DCC reply was likely a copy and paste.
If you need additional support please contact us or download our SenSATIVAx and PathoSEEK Customer Validation Guide.