title: Assessment of commutability for candidate certified reference material ERM-BB130 "chloramphenicol in pork".
abstract: Chloramphenicol (CAP), an effective antibiotic against many microorganisms, is meanwhile banned in the EU for treatment of food-producing animals due to adverse health effects. The Institute for Reference Materials and Measurements (IRMM) is currently developing a certified reference material (CRM) for CAP in pork, intended for validation and method performance verifications of analytical methods. The material will be certified using liquid chromatography-tandem mass spectrometry (LC-MS/MS) and gas chromatography-mass spectrometry (GC-MS) methods and has a target CAP level around the minimum required performance limit (MRPL) of 0.3 microg/kg. To prove that the material can be applied as a quality control tool for screening methods, a commutability study was conducted, involving five commercially available enzyme-linked immunosorbent assay kits and one biosensor assay (BiaCore kit). Meat homogenates (cryo-milled wet tissue) with CAP concentrations around the MRPL and the candidate CRM (lyophilised powder) were measured by LC-MS/MS and GC-MS as well as the six screening methods. Pairwise method comparisons of results obtained for the two sample types showed that the CRM can successfully be applied as quality control (QC) sample to all six screening methods. The study suggests that ERM-BB130 is sufficiently commutable with the investigated assays and that laboratories applying one of the investigated kits therefore benefit from using ERM-BB130 to demonstrate the correctness of their results. However, differences among the assays were observed, either in the abundance of bias between screening and confirmatory LC and GC methods, the repeatability of test results, or goodness of fit between the methods.
authors.affiliation: European Commission, Joint Research Centre, Institute for Reference Materials and Measurements (IRMM), Retieseweg 111, 2440, Geel, Belgium. reinhard.zeleny@ec.europa.eu
authors.forename: Reinhard
authors.initials: R
authors.lastname: Zeleny
authors.forename: Håkan
authors.initials: H
authors.lastname: Emteborg
authors.forename: Heinz
authors.initials: H
authors.lastname: Schimmel
mesh_terms: D000818:Animals; D015374:Biosensing Techniques; D002701:Chloramphenicol / Q000032:analysis*; D002853:Chromatography, Liquid; D004797:Enzyme-Linked Immunosorbent Assay; D008401:Gas Chromatography-Mass Spectrometry; D057230:Limit of Detection; D008461:Meat Products / Q000032:analysis*; D012015:Reference Standards; D013552:Swine; D053719:Tandem Mass Spectrometry
chemical_list: D002701:Chloramphenicol