The Validation of Neogen Reveal® Q+ for DON

Background: Reveal® Q+ for DON is an immunochromatographic test for quantitative determination of deoxynivalenol (DON) in grains. Objective: A study was conducted to validate performance of this method for determination of DON in naturally contaminated corn and wheat and in DON-spiked corn/soy blend, soybeans, barley, malted barley, buckwheat, brown rice, sorghum, and distillers dried grain. Methods: In addition to matrix testing, LOD, linearity, selectivity, robustness, and stability/lot-to-lot consistency testing were performed. Results: The LOD was determined to be 0.014 ppm in corn and 0.037 ppm in wheat, and the LOQ 0.042 ppm in corn and 0.11 ppm in wheat. Recovery ranged from 90 to 104% across a range of reference values of 0.5 to 34.5 ppm. Linearity calculation comparing test results with reference values produced R2 values of 0.999 in both matrixes. Internal results with corn and wheat were corroborated in independent laboratory testing. For DON-spiked commodities, mean recovery across a range of DON concentration from 0.5 to 30 ppm ranged from 90 to 109%. Results of selectivity testing showed no cross-reactivity with other mycotoxins and no interference in detection of DON. Reagent lot-to-lot consistency and stability studies showed consistent results across a range of DON levels and established expiration dating for the test of 18 months after manufacture when stored under specified conditions. Conclusions and Highlights: The Reveal Q+ for DON test offers reliable performance as well as the advantages of aqueous sample extraction, procedural simplicity, minimal labor and equipment requirements, and rapid results. Conclusions: The Reveal Q+ for DON test is validated as a Performace Tested Method in Corn, Wheat, and a variety of other grains. Highlights: The test provides rapid results from a simple aqueous extraction and requires minimal labor and equipment.

Stability Matrix Designs: A Boon For Stability Testing of Pharmaceutical Drug Products.

Long term stability is done in a matrix approach after manufacturing of drug for ensuring the stability of drugs. Using the matrix basic design which is useful for testing 3 lots under one storage condition can be expanded to multiple presentation of products or multiple storage conditions. The design shows full testing at the end points (0 and 36 months) and shows partial testing at the interim time points (3, 6, 9, 12, 18 &24 min). With the assistance of a statistical search algorithm, the test points are selected . 37.5% reduction in analytical testing, while permitting a reliable interim expiry estimate. Based on 12 months stability data it is provided by the proposed matrix design. The matrix approach obtained by expiration dating periods is typically more conservative than the approaches derived from the full testing estimate. The comparison of expiration dating estimate for meter dose inhaler and capsules is presented using the matrixed and full testing approaches.