Trueness assessment of routine electrolytes measuring systems using the candidate reference method by ion chromatography

Abstract

Electrolytes for sodium, potassium, magnesium, and calcium are important serum ions that are frequently assayed in clinical laboratories. In this study, we assessed the trueness of routine analytical systems for four cations using an inexpensive candidate reference method aimed to promote the standardization of serum electrolyte detection. An ion chromatography (IC) method with Cesium as an internal standard was developed and evaluated. The residual clinical serum samples at Chaoyang Hospital were collected and prepared into three human serum pools of electrolytes, which were used for the trueness evaluation of five routine analytical systems. Furthermore, the agreement between routine methods and the IC method was verified using 40 individual human samples. The recovery rates of sodium, potassium, magnesium and calcium were 99.69%, 100.34%, 100.43% and 99.89%, respectively. The intra-batch standard deviation and intra-laboratory precision of NIST SRM 956c were all less than 1% for the four ions. The certified values were within the validation range, and the deviation between the results and the certified values were less than 0.5%. The three serum pools were homogeneous and stable. All routine systems aligned with the IC method for four cations and achieved the analytical quality specifications for potassium and magnesium at 3 different concentrations. The developed IC method is simple, practical, accurate, and precise, which can be used as a candidate reference method for serum electrolytes measurement. Five routine analytical systems for electrolytes measurement had the acceptable bias for potassium and magnesium and their results showed good concordance.

Keywords:

• Ion chromatography
• electrolytes
• candidate reference method
• reference material
• standardization

Disclosure statement

The authors declare that there are no conflicts of interest.

Additional information

Funding

This study was supported by the National Natural Science Foundation of China [81501802] and the Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding Support [ZYLX201811], and 1351 Talent Training Plan [CYMY-2017-01 and CYXX-2017-01].