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在儿科环境下对 VITROS 5600 集成系统进行分析评估,并确定儿科参考区间。

Analytical evaluation of the VITROS 5600 Integrated System in a pediatric setting and determination of pediatric reference intervals.

机构信息

Faculty of Medicine, Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Ontario, Canada.

出版信息

Clin Biochem. 2010 Sep;43(13-14):1039-44. doi: 10.1016/j.clinbiochem.2010.05.011. Epub 2010 May 23.

DOI:10.1016/j.clinbiochem.2010.05.011
PMID:20501331
Abstract

OBJECTIVES

To evaluate the VITROS 5600 Integrated System in a pediatric setting and to determine age- and gender-specific pediatric reference intervals for several common analytes.

DESIGN AND METHODS

The instrument was evaluated using QC material and patient samples. Reference intervals were determined using samples obtained from children attending select outpatient clinics.

RESULTS

Imprecision analysis for 25 analytes and serum indices, the turnaround time for a simulated workload, and MicroSensor performance were assessed in our pediatric laboratory. Pediatric reference intervals for 25 analytes were also determined according to the CLSI/IFCC C28-A3 guidelines using 770 samples and over 15,000 analyses.

CONCLUSION

The VITROS 5600 Integrated System is suitable for use in a pediatric setting. Age- and gender-partitioned pediatric reference intervals for 25 common analytes were also determined as a pilot to the ongoing CALIPER project. These reference intervals are valuable for all VITROS users as well as any laboratory assessing these analytes once they demonstrate the acceptability of transference to their laboratory.

摘要

目的

评估 VITROS 5600 集成系统在儿科环境中的性能,并确定几个常见分析物的年龄和性别特异性儿科参考区间。

设计和方法

使用 QC 材料和患者样本对仪器进行评估。参考区间是通过从参加特定门诊诊所的儿童获得的样本确定的。

结果

在我们的儿科实验室中,评估了 25 种分析物和血清指标的精密度分析、模拟工作量的周转时间以及 MicroSensor 的性能。还根据 CLSI/IFCC C28-A3 指南使用 770 个样本和超过 15000 次分析,确定了 25 种常见分析物的儿科参考区间。

结论

VITROS 5600 集成系统适合在儿科环境中使用。还确定了 25 种常见分析物的年龄和性别分区儿科参考区间,作为正在进行的 CALIPER 项目的试点。这些参考区间对所有 VITROS 用户以及任何实验室都有价值,一旦他们证明将这些分析物转移到他们的实验室是可以接受的,就可以使用这些参考区间。

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