Haeckel R, Bonini P, Ceriotti G, Kutter D, Vonderschmitt D J
J Clin Chem Clin Biochem. 1985 Aug;23(8):473-92.
A multi-centre evaluation of the test strip analyser, Rapimat, was performed by four laboratories following the ECCLS 2nd draft guidelines for the evaluation of analysers in clinical chemistry. Using the Rapignost urine test strip with the test fields for bilirubin, urobilinogen, acetoacetate, ascorbic acid, glucose, protein, nitrite, pH and haemoglobin, the Rapimat was found to be analytically reliable in comparison with other, in most cases quantitative procedures. During the observation period of about 6 months no breakdown occurred in any laboratory. Interferences and sensitivity as discussed for the bilirubin and urobilinogen test field are more related to the test strip than to the instrument. Several improvements for further developments are suggested. This multi-centre study has shown that the ECCLS protocol is applicable to analytical procedures leading to discrete results.
四个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第二版草案，对Rapimat试纸分析仪进行了多中心评估。使用带有胆红素、尿胆原、乙酰乙酸、抗坏血酸、葡萄糖、蛋白质、亚硝酸盐、pH值和血红蛋白检测区域的Rapignost尿试纸，发现与大多数情况下的其他定量方法相比，Rapimat分析仪在分析上是可靠的。在大约6个月的观察期内，任何实验室都没有出现故障。胆红素和尿胆原检测区域所讨论的干扰和灵敏度更多地与试纸有关，而非仪器。建议了一些进一步改进的方向。这项多中心研究表明，ECCLS方案适用于产生离散结果的分析程序。
