A species-specific hydrolysis probe assay was developed, validated, and evaluated for the performance of the assay in accurately identifying the species of interest using the following analytical validation criteria:
(1) specificity (accuracy) in identifying the target species ingredient, while not identifying other non-target species;
(2) sensitivity in detecting the smallest amount of the target material;
(3) reliability (repeatability and reproducibility) in detecting the target species in raw materials on a real-time PCR platform.
NHP ALLIANCE
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