Multicentre performance evaluation of the E170 module for MODULAR ANALYTICS

The E170 module was evaluated at 13 sites in an international multicentre study. The objective of the study was to assess the analytical performance of 49 analytes, and to collect feedback on the systems reliability and practicability. The typical, withinrun coefficients of variation (CVs) for most of the quantitative assays ranged between 1 and 2% while a range of 24% was achieved with the infectious disease methods. Total precision CVs were found to be within the manufacturers expected performance ranges, demonstrating good concordance of the systems measuring channels and a high reproducibility during the 24-week trial period. The functional sensitivity of 11 selected assays met the clinical requirements (e.g., thyreotroponin (TSH) 0.008 mU/l, troponin T 0.02 mug/l, total prostatespecific antigen (PSA) 0.03 mug/l). The E170 showed no drift during an 8-hour period and no relevant reagent carryover. Accuracy was confirmed by ring trial experiments and method comparisons vs. Elecsys(R) 2010. The reliability and practicability of the systems hardware and software met with, or even exceeded, the evaluators requirements. Workflow studies showed that E170 can cover the combined workload of various routine analysers in a variety of laboratory environment. Throughput and sample processing time requirements were achieved while personnel handsontime could be reduced.