Value assigned and application of trueness verification materials of serum electrolytes

doi:10.3969/j.issn.1006-7795.2021.05.002

Abstract

Abstract: Objective To determine the accurate values of serum electrolytes sodium (Na), potassium (K), magnesium (Mg) and calcium (Ca) by ion chromatography reference method, and to apply to the trueness verification of Beijing Center for Clinical Laboratories. Methods Using the established reference method by ion chromatography, the developed three concentration levels (batch numbers BCCL01, BCCL02 and BCCL03) of human serum matrix electrolyte correctness verification materials were determined, and the electrolyte standard reference materials standard reference material (SRM) 919b, SRM 918b, SRM 929a and SRM 915b from the National Institute of Standards and Technology (NIST)were used for quantity transfer. The five levels of sodium, potassium, magnesium and calcium composite ion standard solutions with NIST electrolyte reference materials were prepared to standard curves, the low, medium and high levels correctness verification materials were assigned values and the corresponding uncertainty were calculated. This substance was used to carry out the correctness verification plan in 23 laboratories in Beijing. The correctness verification samples were distributed by Beijing clinical testing center and the results were statistically reported on time. According to Clinical Laboratory Standards Institute (CLSI) EP-17A2, the covariance model and Westgard model are used to estimate the total laboratory error. Results The determination results of three batches of serum electrolyte sodium from correctness verification substance were 125.6-159.1 mmol/L respectively, potassium was 6.134-3.027 mmol/L respectively, magnesium was 1.389-0.539 mmol/L respectively, calcium was 3.083-2.197 mmol/L respectively. The results of Westgard model are similar to the results of 100% passing rate of participating laboratories, while the results of covariance model are only similar to the results of 60% passing rate. Conclusion In this study, the accurate and reliable reference method of ion chromatography is used to assign value of electrolyte sodium, potassium, magnesium and calcium, which can be used to evaluate the accuracy of conventional detection methods in clinical laboratory. Compared with the covariance model, Westgard model is more suitable for the reflection of detection level of the laboratory, so it is recommended that clinical laboratories use Westgard model to estimate the total error in the determination of serum cations.

Key words: electrolyte, ion chromatographic, trueness verification, uncertainty, total errors

CLC Number:

R446.1

Zhang Rui, Zhang Shunli, Liu Wensong, Li Huiling, Wang Ning, Yue Yuhong, Wang Qingtao. Value assigned and application of trueness verification materials of serum electrolytes[J]. Journal of Capital Medical University, 2021, 42(5): 698-705.

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URL: https://journal03.magtech.org.cn/Jweb_sdykdxxb/EN/10.3969/j.issn.1006-7795.2021.05.002

https://journal03.magtech.org.cn/Jweb_sdykdxxb/EN/Y2021/V42/I5/698

References

[1] 陈文祥.临床检验量值溯源与参考系统[J]. 中华检验医学杂志, 2006, 29(1):17-19.
[2] Panteghini M. Traceability as a unique tool to improve standardization in laboratory medicine [J]. Clin Biochem, 2009, 42(4-5):236-240.
[3] David A. Metrological traceability of assays and comparability of patient test results [J]. Clin Lab Med, 2017, 37(1):119-135.
[4] Zhang R, Wang Q T. Comparability of four clinical laboratory measurement methods for GGT and commutability of candidate reference materials [J]. J Clin Lab Anal, 2020, 34(12):e23557.
[5] Wang Y F, Hu X F, Tang J L, et al. Traceability to a primary reference measurement procedure (ID-LCMS); A key step in validating the clinical accuracy and safety of hospital blood glucose monitoring systems [J]. Clin Chim Acta, 2018, 486:275-281.
[6] Aloisio E, Frusciante E, Pasqualetti S, et al. Traceability of alkaline phosphatase measurement may also vary considerably using the same analytical system: the case of Abbott Architect [J]. Clin Chem Lab Med, 2018, 56(6):e135-e137.
[7] 王惠民,王清涛. 临床实验室管理学[M]. 北京:高等教育出版社,2012.
[8] Niraula A, Bataju M. External quality assessment practices in clinical biochemistry laboratory: what is the need? [J]. Kathmandu Univ Med J (KUMJ), 2020, 18(69):86-92.
[9] Braga F, Pasqualetti S, Panteghini M, et al. The role of external quality assessment in the verification of in vitro medical diagnostics in the traceability era [J]. Clin Biochem, 2018, 57:23-28.
[10]中国合格评定国家认可委员会.ISO 15189:2012,IDT CNAS-CL02.医学实验室质量和能力认可准则[M].北京:中国合格评定认可委员会,2012.
[11]Thienpont L M, Van Nuwenborg J E, Stöckl D. Ion chromatography as potential reference methodology for the determination of total calcium and magnesium in human serum[J]. Anal Chem,1994,66(14):2404-2408.
[12]ISO Guide 34. General requirements for the competence of refer-ence material producers[S].Switzer: Geneva, 2009.
[13]CLSI. CLSI document EP17-A2, evaluation of detection capability for clinical laboratory measurement procedures[M]. 2nd Ed.Wayne: CLSI, 2012.
[14]Ge M L, Zhao H J, Yan Y, et al. Performance of electrolyte measurements assessed by a trueness verification program [J]. Clin Chem Lab Med, 2016, 54(8):1319-1327.
[15]Jansen R, Jassam N, Thomas A, et al. A category 1 EQA scheme for comparison of laboratory performance and method performance: an international pilot study in the framework of the calibration 2000 project [J]. Clin Chim Acta, 2014, 432:90-98.
[16]Bukve T, Stavelin A, Sandberg S. Effect of participating in a quality improvement system over time for point-of-care c-reactive protein, glucose, and hemoglobin testing [J]. Clin Chem, 2016, 62(11):1474-1481.
[17]王建新,王惠民,季伙燕,等. 临床实验室测量不确定度评定初步研究[J].国际检验医学杂志, 2014,35(7):894-897.
[18]Yu B B,Yang H. Evaluation of different estimation methods for accuracy and precision in biological assay validation[J].PDA J Pharm Sci Technol, 2017, 71(4):297-305.
[19]Yan Y, Han B, Zeng J, et al. A candidate reference method for serum potassium measurement by inductively coupled plasma mass spectrometry[J]. Clin Chem Lab Med, 2017, 55(10):1517-1522.
[20]Zhang R, Zhang S L, Wang Q T. Trueness assessment of routine electrolytes measuring systems using the candidate reference method by ion chromatography[J]. Scand J Clin Lab Invest, 2021, 81(2):85-91.