Knedel M, Assmann G, Courbe A, van Impe L, Kattermann R, Keller H, Oellerich M, Küppers R, Meyer H D, Willnow P
Klinikum Grosshadern, Munich.
J Clin Chem Clin Biochem. 1988 Mar;26(3):149-62. doi: 10.1515/cclm.1988.26.3.149.
The ES 600 sample-selective multibatch analyser was subjected to a multicentre evaluation in six laboratories in accordance with ECCLS guide-lines. During the 3-month trial, five Enzymun-Test diagnostics (T4, TBG, Digoxin, CEA and TSH)1) were measured at 25 degrees C. The study yielded the following results: 1. The within-series and between-series precision were very good, with mean CV's of approx. 3% and 7% respectively. 2. Recovery of the target values for three control sera was in the range +/- 5%. 3. A trend in measurements did not occur in any of the methods investigated (for series of over 240 determinations). 4. Comparison of the results with those obtained on the ES 22 Enzymun-Test system showed good agreement. 5. Within the measuring range defined by the standards, no deviations could be ascertained upon dilution of the samples. 6. Total carry-over in the instrument was below 0.05%. From studies with instruments from the first production series, it became evident that modifications were necessary to improve the reliability. A follow-up measuring programme confirmed a clear improvement in reliability and a reduction in the imprecision, particularly for results from series to series.
ES 600样本选择性多批次分析仪按照欧洲临床化学和实验室医学学会（ECCLS）指南在六个实验室进行了多中心评估。在为期3个月的试验期间，在25摄氏度下对五项酶免疫分析诊断项目（T4、甲状腺素结合球蛋白、地高辛、癌胚抗原和促甲状腺激素）进行了检测。研究得出以下结果：1. 批内和批间精密度非常好，平均变异系数分别约为3%和7%。2. 三种对照血清的靶值回收率在±5%范围内。3. 在任何被研究的方法中（对于超过240次测定的系列）均未出现测量趋势。4. 将结果与在ES 22酶免疫分析系统上获得的结果进行比较，显示出良好的一致性。5. 在标准定义的测量范围内，对样品进行稀释时未发现偏差。6. 仪器的总携带污染率低于0.05%。从对第一批生产系列仪器的研究中可以明显看出，有必要进行改进以提高可靠性。一项后续测量计划证实可靠性有了明显提高，不精密度有所降低，尤其是批与批之间的结果。
