Study of In-house Internal QCMs Efficiency for Serum Copper Analysis

Authors

  • Thitaporn Tusai Faculty of Medical Technology, Mahidol University
  • Jareanporn Julchoo Faculty of Medical Technology, Mahidol University
  • Phannee Pidetcha Faculty of Allied Health Sciences, Chulalongkorn University
  • Tunyamai Intorn Faculty of Medical Technology, Mahidol University

DOI:

https://doi.org/10.14456/jmu.2023.5

Keywords:

Copper, Homogeneity, in-house Quality Control Material, internal quality control (IQC), Stability

Abstract

           The Toxicology Laboratory, Faculty of Medical Technology, Mahidol University had been developed and produced In-house Quality Control Materials (QCMs) of serum copper analysis for replacement. In order to ensure the efficiency of in-house QCMs, the researchers aimed to study the characteristic of this in-house QCMs by following ISO Guide 80:2014. Homogeneity and seven-month study of stability were investigated.            The results showed that the concentration of In-house QCMs were 73 and 143 µg/dL (%CV = 2.32, 1.61, respectively) showing relatively low variance and had %recovery 102, 104, respectively. The statistical analysis for homogeneity assessment (F test) showed the value of calculated F less than Fcritical, and p-value > 0.05 (p-value = 0.215, 0.051, respectively) indicating the homogeneity. The linear regression slope of stability assessment showed 95% CI and p-value > 0.05 indicating the stability up to 6 months of both levels.

           These results imply that the in-house QCMs had efficiency required according to ISO Guide 80: 2014 statistics and also had appropriate value for using in routine laboratory. Moreover, the process and statistical analysis method in this study could be applied in other In-house QCMs.

References

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Published

2023-04-12

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Research Articles