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 system's reliability and practicability. The typical, within-run coefficients of variation (CVs) for most of the quantitative assays ranged between 1 and 2% while a range of 2-4% was achieved with the infectious disease methods. Total precision CVs were found to be within the manufacturer's expected performance ranges, demonstrating good concordance of the system's measuring channels and a high reproducibility during the 2-4-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 µg/l, total prostate-specific antigen (PSA) 0.03 µg/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® 2010. The reliability and practicability of the system's hardware and software met with, or even exceeded, the evaluator's 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 ‘hands-on-time' could be reduce

Instrumentalanalyse, Automation und Robotics in der Klinischen Chemie: Instrumental Analysis, Automation and Robotics in Clinical Chemistry

Clinical chemistry is probably the part of analytical chemistry which is under the greatest pressure with respect to productivity. This results in methods completely different from those used in classical analytical chemistry. Separation methods and the determination of the concentrations of the separated components are usually not possible because of the inherent slowness of the procedures. This is true except in situations where closely related substances that occur as mixtures in biological fluids are to be measured (amino acids, proteins, sugars, fatty acids, drugs and their metabolites). For these special conditions GC-MS, LC-MS and other instrumental methods can be used. For the bulk of tests, however, chemical (photometric), enzymatic, immunological and genetic methods are applied. The components to be measured are specifically determined within the complex biological matrix without prior separation. The often complicated reactions lead to products that can be assessed by photometry, turbidometry, nephelometry or fluorometry. Samples (serum, plasma, urine) are processed in automated devices with high test frequency. Characteristic data are: sample volume 5 to 10 ?l, time of analysis 8 to 10 min, test frequency 200 to 300 tests per hour. For the determination of simple ions ion-selective electrodes are used. Increasingly, robots are engaged for sample preparation, reading of sample identification, centrifugation, decapping of test tubes, aliquoting and identification of aliquot tubes. Instrumental analysis, automation and robotics would be useless without laboratory information systems. Such systems allow the doctor to order the tests from his office terminal. According to the request, barcodes are printed to identify the sample tubes. The samples with barcode but without any accompanying form are taken to the laboratory and the reading of the barcode triggers the download of the request into the laboratory system