PathogenDx DetectX Combined Demonstrates Equivalent Performance in Comparison to Four AOAC Certified Methods for the Detection of Aspergillus species, Salmonella species, and STEC in Dried Hemp Flower


The PathogenDx DetectX Combined method is a certified Performance Tested Method SM (#012201) that is enrichment free and utilizes DNA microarray-based end point PCR method for the simultaneous detection of Aspergillus (Aspergillus flavus, Aspergillus fumigatus, Aspergillus niger and Aspergillus terreus), Salmonella spp. and a broad range of STEC from hemp and cannabis flower, edibles, and concentrates.


This study aimed to compare the PathogenDx DetectX Combined enrichment free method to four AOAC certified molecular methods that utilize enrichment prior to qPCR amplification in hemp flower for the detection of Aspergillus (Aspergillus flavus), Salmonella enterica, and Escherichia coli 026.


In this method comparison study, each method was evaluated according to the AOAC validated instructions for use (IFU) and the AOAC Appendix J validation guidelines. A total of 16 samples at three levels of contamination (0, 0.7, and 2 CFU/10g Test portion) were analyzed by each method. The results for all methods were evaluated by using the Probability of Detection statistical model (POD).


Results of the validation study demonstrate that the PathogenDx DetectX Combined enrichment free method is equivalent in performance to the three proprietary methods evaluated in this study.


The method comparison study indicated that the PathogenDx DetectX Combined enrichment free method provides equivalent detection of the target analytes (Aspergillus flavus, Salmonella and a broad range of STEC) in hemp flower.


The performance of The PathogenDx DetectX Combined method is significantly faster and possesses a higher or equivalent degree of sensitivity and specificity. Implementation of this method for routine microbial pathogen analysis in laboratories would save significant time and resources.

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