Evaluation of Uniformity and Stability of Frozen Mixed Serum Potassium Candidate Reference Materials

被引:0
|
作者
Zhang, Rui [1 ]
Zhang, Dan [1 ]
Wang, Qingtao [1 ,2 ]
机构
[1] Capital Med Univ, Beijing Chao Yang Hosp, Dept Clin Lab, 8 Gongtinan Rd, Beijing 100020, Peoples R China
[2] Beijing Ctr Clin Labs, Beijing, Peoples R China
基金
中国国家自然科学基金;
关键词
potassium; candidate reference material; uniformity; stability; TRACEABILITY; STANDARDIZATION;
D O I
10.7754/Clin.Lab.2019.190803
中图分类号
R446 [实验室诊断]; R-33 [实验医学、医学实验];
学科分类号
1001 ;
摘要
Background: We tested the uniformity and stability of candidate reference materials (RMs) for serum potassium and aimed to design RMs with better quality that can meet all clinical test requirements and effectively solve the quantity traceability transfer problem. Methods: Three levels of frozen mixed serum potassium candidate RMs were prepared and packed in freezing tubes. RMs were determined in triplicate in 10 vials randomly selected from each level. A one-way analysis of variance was used to evaluate the uniformity using a ratio of the mean squares among groups to mean squares within groups F < F-0.05 as the criteria. Stability was studied by synchronization; the short-term stability of the serum potassium in the transport conditions was observed for 30, 15, and 7 days at refrigeration (2 - 8 degrees C), room temperature (18 - 25 degrees C), and 37 degrees C, respectively. By linear regression analysis of variance, the straight line was used as an empirical model. The criterion for judging is vertical bar b1 vertical bar < t(0.95, n - 2).S-b1. Results: Based on the statistical analysis using SPSS 17, the F values for the homogeneity tests of each level of the frozen mixed serum potassium RMs were 0.247, 0.117, and 0.162. These values were less than F-0.05(9,F- 20) = 2.39. When the short-term stability of the serum potassium was observed for 30, 12, and 4 days at 2 - 8 degrees C, room temperature, and 37 degrees C, respectively, vertical bar b1 vertical bar < t(0.95, n - 2).S-b1, and instability was not observed. Conclusions: The three levels of the frozen mixed serum potassium RMs have good uniformity. At 2 - 8 degrees C, room temperature, and 37 degrees C, the stability can be ensured for at least 30, 12, and 4 days, respectively. The serum potassium candidate RMs are sufficiently stable under these transportation conditions.
引用
收藏
页码:595 / 601
页数:7
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