A multicenter evaluation of the Boehringer Mannheim ES 300 immunoassay system.
The ES 300 system, a fully automated multichannel immunoassay analyzer, was evaluated simultaneously for 9 weeks in four major centers. Precision, accuracy, carryover, comparison to in-house methods, and interferences were assessed for the following 17 tests: T4, T3, FT4, TSH, TBK, TBG, LH, FSH, prolactin, HCG, digoxin, cortisol, ferritin, IgE, insulin, AFP, and CEA. All centers reported good intra-lab and inter-lab precision. Accuracy was judged to be good based on correlation with in-house methods and recovery of target values in commercial and proficiency control materials. Linearity was evaluated for 14 analytes. Method biases were observed for T3 and insulin that were attributed to differences in standardization. No significant interferences from bilirubin, lipemia, and hemolysis were observed for all methods except insulin and AFP. Featuring random access capability, low daily maintenance, and high throughput, the ES 300 system performed well and met the stated claims of the manufacturer.