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Loganville, GA, United States

Polakowski S.,EnviroLogix Inc. | Roberts R.W.,EnviroLogix Inc. | Tanguay K.,EnviroLogix Inc. | Bailey C.,EnviroLogix Inc. | And 5 more authors.
Journal of AOAC International | Year: 2015

The QuickTox Kit for QuickScan Aflatoxin FREE uses competitive lateral flow technology and a reader based system for quantitative determination of total aflatoxins in varied matrixes. Aqueous based extraction protocols are used for corn and wheat, reducing use of solvents. Fifty percent ethanol (Reagent Alcohol) extraction is used for oats, sorghum, and barley. Eighty percent ethanol (Reagent Alcohol) extraction is used for whole peanut, peanut seed, and peanut hull samples. Matrix specific assay procedures and calibration curves are used to enable analyses across multiple sample types. The performance of this assay was examined using naturally contaminated aflatoxin corn samples and spiked samples of barley, oats, sorghum, wheat, whole peanut, peanut seed, and peanut hull samples. All data were judged against previously established acceptance criteria. Performance was evaluated in linearity, selectivity, matrix, lot consistency, and robustness experiments in the sponsor's laboratory. Results produced in all studies except robustness were within acceptable ranges. Out of range robustness study results reflected simultaneous deviation in sample volume and assay development time compared to the standard assay procedures. Aflatoxin B1, B2, and G1 were detected with approximately equal sensitivity; sensitivity for G2 was 64% that of B1. The presence of other common mycotoxins did not interfere with the assay. Matrix studies in an independent laboratory examined corn and barley to challenge both aqueous and ethanol based extraction procedures. All data points in these studies fell within the ranges defined in the acceptance criteria. The assay exhibited a linear dose response over the range tested, 0-100 ppb, with R2 values exceeding 0.93 and RSDr values for results ranging from 2.27 to 23.84%.

Trombley A.,Beacon Analytical Systems Inc. | Fan T.,Beacon Analytical Systems Inc. | Labudde R.,Least Cost Formulations Ltd | Shephard G.S.,South African Medical Research Council | And 2 more authors.
Journal of AOAC International | Year: 2011

The level of total aflatoxin contamination was analyzed in naturally contaminated and spiked samples of corn and peanut using the Aflatoxin Plate Kit. This kit is an enzyme-linked immunosorbent assay (ELISA) suitable for rapid testing of grains and peanuts. The assay was evaluated for ruggedness and linearity of the standard curve. The test kit results were then statistically evaluated for accuracy, precision, and correlation to a validated HPLC method (AOAC 994.08). The results were verified by an independent laboratory. © 2012 Publishing Technology.

Okochi N.,Dai Nippon Printing | Yamazaki M.,Dai Nippon Printing | Kiso S.,Dai Nippon Printing | Kinoshita M.,Dai Nippon Printing | And 6 more authors.
Journal of AOAC International | Year: 2014

A ready-made dry medium method for aerobic count, the Medi.Ca AC method, was compared to the AOAC Official Method 966.23, Microbiological Methods, for seven different heat-processed meat matrixes: cooked roast beef, Chinese barbecued pork (barbecued pork seasoned with honey-based sauce), bacon, cooked ham, frankfurter (made from beef and pork), and boiled and cooked pork sausage. The 95% confidence interval for the mean difference between the two methods at each contamination level for each matrix fell within the range of -0.50 to 0.50, and no statistical difference was observed at all three contamination levels for five matrixes. These results demonstrate that the Medi.Ca AC method is a reasonable alternative to the AOAC 966.23 method for cooked meat products.

Joelsson A.C.,Invisible Sentinel | Brown A.S.,Invisible Sentinel | Puri A.,Invisible Sentinel | Keough M.P.,Invisible Sentinel | And 8 more authors.
Journal of AOAC International | Year: 2014

Veriflow® Campylobacter is a molecular based assay for the presumptive and qualitative detection of the most common occurring foodborne Campylobacter species: C. jejuni and C. coli. The assay utilizes a PCR detection method coupled with a rapid, visual, flow-based assay that develops in 3 min post PCR amplification and requires only 24 h of non-specialized enrichment for maximum sensitivity. The Veriflow Campylobacter system eliminates the need for microaerobic chambers, gel electrophoresis or fluorophore based detection of target amplification, and does not require complex data analysis. This Performance Tested MethodSM validation study demonstrated the ability of the Veriflow method to detect naturally occurring Campylobacter from chicken carcass rinsates. In the reference comparison study, Chi-square and probability of detection analyses of two unpaired studies indicated that there was no significant difference between the Veriflow Campylobacter method and the U.S. Department of Agriculture (USDA)/Food Safety and Inspection Service (FSIS) reference method. There was no indication of false positive or false negative detection in the reference comparison study, and all 50 C. jejuni and C. coli strains were detected, while 35 nonspecific organisms were undetected in the exclusivity/ inclusivity study. The study results show that Veriflow Campylobacter is a sensitive, selective and robust assay for the detection of C. jejuni and C. coli in chicken carcass rinsates.

Polakowski S.,EnviroLogix Inc. | Polakowski S.,Submitting Company | Polakowski S.,Independent Laboratory Trilogy Analytical Laboratory | Davis A.H.,EnviroLogix Inc. | And 10 more authors.
Journal of AOAC International | Year: 2015

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 Method (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 R 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.

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