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用于罗氏cobas 6000(c501模块)自动化平台的改良罗氏酶法氨测定方法的评估:5微升样本量时性能的提升。

Evaluation of a Modified Roche Enzymatic Ammonia Method for Roche Cobas 6000 (c501 Module) Automated Platform: When 5 µL Improves Performance.

作者信息

Vassena Christian, Casati Marco, Sala Gabriele, Perlangeli Vittoria, Montagnese Sara, Ippolito Silvia, Carati Lucia

出版信息

Clin Lab. 2016 Dec 1;62(12):2423-2428. doi: 10.7754/Clin.Lab.2016.160336.

Abstract

BACKGROUND

We evaluated a modified Roche NH3L method developed by our group that significantly reduced the error flag "> ABS (> Absorbance)" on the COBAS 6000 (c501 module) automated platform.

METHODS

Our study was finalized to validate the NH3L open method on COBAS 6000 (c501 module) with imprecision and correlation tests. In addition, the NH3L open method was evaluated for determination of lower limit of blank (LoB), lower limit of detection (LoD), and accuracy.

RESULTS

The imprecision test showed good results with CV for all samples tested < 3 and < 5 for within-run and between-run assays. Correlation tests of NH3L classic and NH3L open method showed good correlation with R square = 0.95. "> ABS" obtained with the NH3L open were only 2% compared to NH3L classic method.

CONCLUSIONS

Our study shows that the NH3L open method is reproducible and stable, providing values which correlate with those obtained by the traditional method. The ability to reduce the alarm > ABS by more than 95% thanks to lower background absorbance values makes this method reliable, avoiding re-testing or the need for sample dilutions.

摘要

背景

我们评估了由我们团队开发的改良罗氏 NH3L 方法,该方法显著减少了 COBAS 6000(c501 模块)自动化平台上的错误标记“> ABS(>吸光度)”。

方法

我们的研究最终确定通过不精密度和相关性测试来验证 COBAS 6000(c501 模块)上的 NH3L 开放方法。此外,还对 NH3L 开放方法进行了空白下限(LoB)、检测下限(LoD)和准确性的评估。

结果

不精密度测试结果良好,所有测试样品的批内和批间测定的 CV 均<3 和<5。NH3L 经典方法和 NH3L 开放方法的相关性测试显示出良好的相关性,R 平方=0.95。与 NH3L 经典方法相比,NH3L 开放方法获得的“> ABS”仅为 2%。

结论

我们的研究表明,NH3L 开放方法具有可重复性和稳定性,提供的值与传统方法获得的值相关。由于背景吸光度值较低,能够将>ABS 警报减少 95%以上,使得该方法可靠,避免了重新测试或样品稀释的需要。

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