A Simple and Accurate Measurement Procedure for Serum Chloride by Ion Chromatography and Bias Evaluation of Six Ion Selective Electrode Measurements in China

Abstract

Background: Chloride is the main anion in human body. A simple and accurate method for serum chloride measurement was developed using ion chromatography (IC) in China. Methods: In the measurement, serum samples were diluted 500 times with water, filtered and injected into ion chromatography column. A mixed eluent (2 mmol/L CO3 2-+ 12 mmol/L OH-) was used and peak area signal was collected. Five calibrators made from Standard Reference Material (SRM) 919b were used in the bracketing method. The IC method was applied as the comparative method and six ion selective electrode (ISE) measurement systems were evaluated using 60 individual patient serums. Results: The IC method was proven to be accurate. The precision was 0.18%-0.30%, the recovery was 99.66%-100.60%, the bias was 0.19% to-0.06%, and the related expanded uncertainty was 0.775% (k = 2). The precisions of the ISE systems were smaller than the 0.9% tolerable CV except for the Beckman DXC (0.91%-1.16%). In comparison, the results of linear regression analysis showed that the correlation coefficients were 0.9876 to 0.9979. For all systems, the range of mean biases was-5.96-1.48 mmol/L (-5.57%-1.36%); the expected biases at the medical decision levels were-4.97%-0.84% at 90 mmol/L and-6.02%-1.76% at 120 mmol/L. All biases of the Beckman AU met the requirement of within ± 1.5%. Conclusions: The IC measurement method is proven to be of high precision and trueness, and the quality of routine ISE measurement of serum chloride still needs significant improvement. The establishment of the IC method can improve the measurement quality and promote its standardization process in China.