Validation of the SL3 beta-Lactam Test for screening milk in compliance with U.S. pasteurized milk ordinance: performance tested method 040701

The SL3 beta-Lactam Test is a 3 min, receptor-based lateral flow Rapid One Step Assay (ROSA) that detects 5 of 6 beta-lactam drugs approved for dairy cattle in the United States. The method was evaluated through the AOAC Research Institute Performance-Tested Method program following a U.S. Food and Drug Administration protocol. Three combined lots detected penicillin G 4.2 parts per billion (ppb), ampicillin 8.7 ppb, amoxicillin 7.8 ppb, cephapirin 16.0 ppb, and ceftiofur (total metabolites) 51 ppb at least 90% of the time, with 95% confidence as determined by dose response probit analysis. These detection levels are less than safe level/tolerances but not more than 50% less. Lot repeatability was within 20%. Incurred residues were detected comparably or more sensitively to fortified samples due to the cumulative effect of biologically active metabolites. There were no interferences from somatic cells at 1 M/mL, bacterial cells 500 000 colony-forming units/mL, or 30 other non-beta-lactam drugs. These performances met approval conditions of the National Conference on Interstate Milk Shipments. Ruggedness conditions were incorporated into public health procedures for annual laboratory proficiency and certification.