Steinmann J, Milbradt H, Steinkopf A, Schmidt B, Hellmut M, Weber C, Haeckel R
Staatliches Hygiene-Institut, Bremen.
J Clin Chem Clin Biochem. 1988 Jan;26(1):43-56.
A multi-centre evaluation of the Behring ELISA Processor II in connection with the Enzygnost-tests from Behringwerke was performed by 3 laboratories following the ECCLS Guidelines for the Evaluation of Analysers in Clinical Chemistry. The performance characteristics were studied with analytical tests for anti-HBs1), HBsAg and anti-CMV2). This evaluation represents, to our knowledge, the first trial in clinical virology with guidelines primarily designed for clinical chemistry. The evaluation revealed that the highly automated Behring ELISA Processor II is a reliable tool in the virological laboratory. The data obtained showed low imprecision and good accuracy. The washing unit proved to be very efficient. No carry-over of reagents was detected in the dispenser system. Several improvements for further developments of the analyser are suggested. This multi-centre study has shown that the ECCLS protocol can be used to evaluate analysers and test systems in clinical virology.
3家实验室按照欧洲临床化学实验室标准化委员会（ECCLS）临床化学分析仪评估指南，对贝林ELISA II型分析仪与贝林公司的酶免疫分析检测法联用进行了多中心评估。通过抗-HBs1）、HBsAg和抗-CMV2）的分析检测研究了其性能特征。据我们所知，此次评估是首次主要按照临床化学指南在临床病毒学领域开展的试验。评估显示，高度自动化的贝林ELISA II型分析仪是病毒学实验室的可靠工具。所获数据显示不精密度低且准确性良好。清洗单元证明效率很高。在分配系统中未检测到试剂残留。针对分析仪的进一步改进提出了若干建议。这项多中心研究表明，ECCLS方案可用于评估临床病毒学中的分析仪和检测系统。
