Colombo J P
Schweiz Med Wochenschr. 1987 May 30;117(22):833-40.
Quantitative analysis with dry reagent strips for the determination of clinical chemistry parameters and drug monitoring in serum, plasma and whole blood is expanding in small laboratories and in office laboratories. The systems predominantly used are Ektachem DT 60, the Seralyzer and the Reflotron. - The methods offered comprise substrates, enzymes, electrolytes, CO2 and drugs. The spectrum of feasible tests varies with the manufacturer. On the whole all the tests commonly used in small laboratories are covered. The instruments used for quantitative dry reagent strip chemistry are calibrated by the manufacturer. Calibration data are either inputted to the instrument with each method or already programmed in the apparatus. Thus calibration is outside the control of the user, a change of philosophy which does not correspond to present concepts of quality control in clinical chemistry. The analytical precision is satisfactory for all three instruments for the common parameters measured. A comparison between "dry-chemistry" determinations and the classical aqueous analyses show good accuracy as long as patient samples are used. This is, however, not true for all reference materials, presumably due to matrix effects. Our own evaluation of the Seralyzer showed a good correlation of potassium analysis compared with flame photometry; this was also true of gamma-glutamyltransferase using the Reflotron with patient samples. Internal quality control can only be performed with materials assessed by the instrument manufacturers, and the results will often differ for these materials when assayed with conventional methods or with other "dry-chemistry" methods. External quality control also has its limitations due to the fact that no sera are available which could be used universally.(ABSTRACT TRUNCATED AT 250 WORDS)
使用干试剂条对血清、血浆和全血中的临床化学参数进行定量分析以及进行药物监测,在小型实验室和门诊实验室中正在不断发展。主要使用的系统有Ektachem DT 60、Seralyzer和Reflotron。 - 所提供的方法包括底物、酶、电解质、二氧化碳和药物。可行的检测范围因制造商而异。总体而言,涵盖了小型实验室常用的所有检测项目。用于定量干试剂条化学分析的仪器由制造商进行校准。校准数据要么在每种方法中输入仪器,要么已预先编程到仪器中。因此,校准不在用户控制范围内,这种理念的转变与临床化学当前的质量控制概念不符。对于所测量的常见参数,这三种仪器的分析精度都令人满意。只要使用患者样本,“干化学”测定与经典的水溶液分析之间的比较显示出良好的准确性。然而,对于所有参考物质并非都是如此,可能是由于基质效应。我们自己对Seralyzer的评估表明,与火焰光度法相比,钾分析具有良好的相关性;使用Reflotron对患者样本进行γ-谷氨酰转移酶分析时也是如此。内部质量控制只能使用仪器制造商评估的材料进行,并且当用传统方法或其他“干化学”方法检测这些材料时,结果往往会有所不同。由于没有可普遍使用的血清,外部质量控制也有其局限性。(摘要截短为250字)