title: Validation study of the BetaStar plus lateral flow assay for detection of beta-lactam antibiotics in milk.
abstract: A validation study designed to meet the requirements of the AOAC Research Institute and the U.S. Food and Drug Administration, Center for Veterinary Medicine (FDA/CVM) was conducted for a receptor and antibody-based, immunochromatographic method (BetaStar Plus) for detection of beta-lactam antibiotic residues in raw, commingled bovine milk. The assay was found to detect amoxicillin, ampicillin, ceftiofur, cephapirin, cloxacillin, and penicillin G at levels below the FDA tolerance/safe levels, but above the maximum sensitivity thresholds established by the National Conference on Interstate Milk Shipments (NCIMS). Results of the part I (internal) and part II (independent laboratory) dose-response studies employing spiked samples were in close agreement. The test was able to detect all six drugs at the approximate 90/95% sensitivity levels when presented as incurred residues in milk collected from cows that had been treated with the specific drug. Selectivity of the assay was 100%, as no false-positive results were obtained in testing of 1031 control milk samples. Results of ruggedness experiments established the operating parameter tolerances for the BetaStar Plus assay. Results of cross-reactivity testing established that the assay detects certain other beta-lactam drugs (dicloxacillin and ticarcillin), but it does not cross-react with any of 30 drugs belonging to other classes. Abnormally high bacterial or somatic cell counts in raw milk produced no interference with the ability of the test to detect beta-lactams at tolerance/safe levels.
authors.affiliation: U.S. Food and Drug Administration, Center for Veterinary Medicine, 8401 Muirkirk Rd, Laurel, MD 20708, USA.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Abouzied
authors.forename: Dana
authors.initials: D
authors.lastname: Driksna
authors.forename: Coilin
authors.initials: C
authors.lastname: Walsh
authors.forename: Michael
authors.initials: M
authors.lastname: Sarzynski
authors.forename: Aaron
authors.initials: A
authors.lastname: Walsh
authors.forename: David
authors.initials: D
authors.lastname: Ankrapp
authors.forename: Frank
authors.initials: F
authors.lastname: Klein
authors.forename: Jennifer
authors.initials: J
authors.lastname: Rice
authors.forename: Mark
authors.initials: M
authors.lastname: Mozola
mesh_terms: D000658:Amoxicillin / Q000032:analysis; D000667:Ampicillin / Q000032:analysis; D000818:Animals; D000900:Anti-Bacterial Agents / Q000032:analysis*; D002417:Cattle; D002511:Cephalosporins / Q000032:analysis; D002514:Cephapirin / Q000032:analysis; D002623:Chemistry Techniques, Analytical / Q000379:methods*; D003023:Cloxacillin / Q000032:analysis; D004350:Drug Residues / Q000032:analysis*; D005189:False Positive Reactions; D005506:Food Contamination; D008892:Milk / Q000187:drug effects*; D010400:Penicillin G / Q000032:analysis; D011933:Reagent Kits, Diagnostic; D012015:Reference Standards; D015203:Reproducibility of Results; D014481:United States; D014486:United States Food and Drug Administration; D014730:Veterinary Medicine / Q000379:methods; D047090:beta-Lactams / Q000032:analysis*
chemical_list: D000900:Anti-Bacterial Agents; D002511:Cephalosporins; D011933:Reagent Kits, Diagnostic; D047090:beta-Lactams; D000667:Ampicillin; D000658:Amoxicillin; C053503:ceftiofur; D002514:Cephapirin; D003023:Cloxacillin; D010400:Penicillin G