罗氏Cobas Integra上五种液体稳定性新应用的评价。

G Lippi, C Brentegani, C Mazzi, C Recchi, O Ruzzenente, G Guidi
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引用次数: 0

摘要

本研究对罗氏Cobas Integra的5种新型液体应用的分析性能进行了评价:血清中的尿素和高密度脂蛋白(HDL)胆固醇、葡萄糖、尿中的肌酐和无机磷。根据国家临床实验室标准委员会的协议,分析评估包括不精确度、线性度和与实际Cobas Integra颗粒应用或日立704上的相应方法进行的方法比较。在3个月内获得了超过3700个结果。运行内和日间变异系数(CV)均值分别为1.15%和1.48%,总CV均值为2.17%。5种应用的线性均很好,相对非线性均在1.53%以内,完全满足2.5%的上限。通过比较120个样品与Cobas Integra或日立试剂上相应的颗粒应用的结果,观察到严格的相关性。线性回归分析结果显示,相关系数均在0.987以上,Passing和Bablok回归线斜率与统一偏差不超过7%。在4小时的作业中未观察到漂移。总之,这些新的Cobas Integra液体应用程序的性能,正如本研究所证明的那样,证明它们非常适合临床实验室的常规使用。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of five new liquid stable applications on the Roche Cobas Integra.

In the present study the analytical performances of five new liquid applications on the Roche Cobas Integra were evaluated: urea and high density lipoprotein (HDL) cholesterol in serum and glucose, creatinine and inorganic phosphorus in urine. The analytical evaluation consisted of imprecision, linearity and method comparison performed against either the actual Cobas Integra granulate applications or the corresponding methods on a Hitachi 704, according to the National Committee for Clinical Laboratory Standards protocols. Over 3700 results were obtained within 3 months. Average values of within-run and between-day coefficients of variation (CVs) were 1.15% and 1.48%, respectively, holding to a mean total CV of 2.17%. The linearity was excellent for all the five applications evaluated as the relative non-linearity was always within 1.53%, thus completely fulfilling the 2.5% upper limit. A strict correlation was observed by comparing results of 120 samples with either the corresponding granulate applications on Cobas Integra or the Hitachi reagents. Linear regression analysis of the results yielded correlation coefficients always above 0.987 and the slopes of the Passing & Bablok regression lines did not deviate by more than 7% from unity. No drift was observed over 4 hours of operations. In conclusion, the performance of these new Cobas Integra liquid applications, as demonstrated by the present study, proved them to be highly suitable for routine use in clinical laboratories.

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