Errors of Classification With Potassium Blood Testing: The Variability and Repeatability of Critical Clinical Tests

To understand the performance of a currently used clinical blood test with regard to the frequency and size of variation of the results. From November 29, 2012, through November 29, 2013, patients were recruited at 65 sites as part of a previously reported clinical trial (ClinicalTrials.gov Identifier: NCT01737697). Eligible outpatients who had been fasting for at least 8 hours underwent venous phlebotomy at baseline, 30 minutes, and 60 minutes to measure plasma potassium levels in whole blood using a point-of-care device (i-STAT, Abbott Laboratories). We analyzed the results to assess their variability and frequency of pseudohyperkalemia and pseudonormokalemia. A total of 1170 patients were included in this study. Absolute differences between pairs of measurements from different time points ranged from 0 to 2.5 mmol/L, with a mean difference of 0.26 mmol/L. The mean percentage differences were approximately 5% with an SD of 5%. Approximately 12% of differences between repeated fasting potassium blood test results were above 0.5 mmol/L (33% of the normal range), and 20% of patients (234) had at least one difference greater than 0.5 mmol/L. In 44.0% of the patients with a hyperkalemic average value (true hyperkalemia) (302 of 686), at least one blood test result was in the normal range (pseudonormokalemia), and in 30.2% of the patients with a normal average value (146 of 484), at least one blood test result was elevated (pseudohyperkalemia). Expected variability and errors exist with potassium blood tests, even when conditions are optimized. Pseudohyperkalemia and pseudonormokalemia are common, indicating a need for thoughtful clinical interpretation of unexpected test results.