QuickTox™ Kit for QuickScan DON3 (Vomitoxin) Method Modification

Lateral flow technology and a reader-based system are used for quantitative determination of deoxynivalenol (DON), also known as vomitoxin, residues in cereal grain commodities by the QuickTox Kit for QuickScan DON (Vomitoxin). The assay has been modified, and a study was conducted in support of a Performance Tested MethodSM (PTM) Modification. The modified assay employs identical biologic reagents as used previously (PTM No. 121202). Compared to the PTM certified product, the new assay uses modified device architecture. Multiple kits and catalog numbers were required in the original kit reflecting the necessity for matrix specific calibration curves affixed to assay strips. A single calibration curve and kit are utilized in the new product; extraction volumes used in sample preparation are varied to accommodate multiple sample types. Extracts are clarified by filtration or settling depending on the sample type. Filtration was used for matrixes examined in these studies. With the original product, the extract was mixed 1:1 with DB1 buffer followed by the addition of the strip which was developed for 10 min. The new product dilutes extracts five-fold offline in DB6 buffer; an aliquot of the dilution is moved to a reaction vial followed by strip development time for 3 min. The new assay performance was evaluated for linearity, robustness, selectivity (inclusivity), lot-to-lot consistency, and both internal and third party matrix studies. All DON positive samples yielded results within previously defined acceptable ranges with dose-dependent correlation values of R2 greater than 0.97 in linearity and internal and external matrix studies. Inclusivity data indicated detection of DON along with acetyl derivatives, glucoside-conjugate, and Nivalenol. Robustness studies showed within range results upon co-variation of multiple user interface parameters, and lot-to-lot consistency challenges demonstrated acceptable results across five manufactured lots.