Reference Intervals of Serum Sodium, Potassium, and Chlorine in Chinese Han Population and Comparison of Two ISE Methods.

Abstract

Currently there are no reference intervals (RIs) of sodium (Na), potassium (K), and chlorine (Cl) on Chinese population. Two kinds of ion-selective electrode (ISE) methods were commonly used to determine K, Na, and Cl levels in China, the difference between these two methods needs to be evaluated. A total of 4,524 healthy participants (1,916 males and 2,608 females) between 20-79 years old from six cities in China were selected by strict criteria. Serum K, Na, and CL were tested on Roche Modular analyzers in six assigned laboratories. According to EP-9A2, using Roche Modular analyzer (indirect ISE) as comparative method, Olympus AU 5400 analyzer (indirect ISE) and Johnson&Johnson Fusion 5.1 analyzer (direct ISE) were evaluated. In Chinese population, the RIs for K, Na, and CL are 3.6-5.2, 136-146, and 99-110 mmol/l, respectively. Compared to the Roche indirect ISE method, Johnson direct ISE method showed a positive bias; and Olympus indirect ISE method just showed a very slight bias. The RIs of K, Na, and Cl of Han Chinese healthy adult population were found to be smaller than those provided by the manufacturer. By a criteria of biological variations for CV, the differences of Na and K between Roche analyzer and Johnson analyzer were not acceptable for clinical application, while the differences of Na, K, and Cl between Roche and Olympus analyzers were acceptable for clinical application.