Validation of a Commercial Enzyme-Linked Immunosorbent Assay for Screening Tetracycline Residues in Foods of Animal Origin from the Perspective of Bangladesh

Enzyme-linked Immunosorbent Assay (ELISA) is one of the most important screening methods of antibiotic residue analysis in different food matrices. This study was carried out to validate the ELISA kit of R-Biopharm (RIDASCREEN) for screening tetracycline antibiotic residues in the muscle of chicken, beef, and shrimp in accordance with the European Commission (EC) decision 2002/657/EC. The kit was validated in terms of different characteristic performances, e.g., detection capability, specificity, applicability, ruggedness, and stability. Detection capability CCβ of the method was 100 µg/kg for three types of matrix with a false compliant rate of 5% for beef and chicken, and 0% for shrimp samples. The threshold value T was equal to 1.85, 1.558, and 1.532 OD for beef, chicken, and shrimp samples, respectively, whereas the cut-off value Fm was equal to 0.621, 0.519, and 0.424 OD, respectively. The kit was valid because Fm<T for all the cases. Sensitivity of the kit decreased after six months of first experiment, but still can be used successfully because the Fm values clearly lowered the T values, and the reading ODs did not overlap any ODs of spiked samples. The ELISA kit for tetracycline was robust and cost effective because there was no need to use solid phase extraction. In case of monitoring tetracycline antibiotic residues, the kit is applicable for the muscle of chicken, beef, and also shrimp with the same detection capability value.