Evaluation of a New Automated Routine Measurement for Serum Adjusted Ionized Calcium (at pH 7.4) in Patients Suspected of Calcium Metabolic Disease

J Appl Lab Med. 2020 Jul 1;5(4):704-715. doi: 10.1093/jalm/jfaa006.

Abstract

Background: Total calcium is a less accurate test in predicting ionized calcium (Ca2+) in patients suspected of calcium metabolic disease. Nevertheless, total calcium continues to be used as routine measurement instead of adjusted Ca2+ (at pH 7.4). In the current study we evaluate a new multichannel instrument, the ISE Module E1200 for adjusted Ca2+ (at pH 7.4), containing three different ion-selective electrode (ISE) units.

Methods: Serum from 1350 patients was compared to the ABL835 flex and KoneLab. Total calcium was also evaluated on the Dimension Vista 1500 system. Correlations between instruments were assessed by Deming regression and degree of agreement by Cohen's kappa (κ).

Results: Analytical imprecisions for the three ISE units for adjusted Ca2+ (at pH 7.4) was between 0.36% and 2.52%, and for pH between 0.32% and 3.24%. Results were comparable for each ISE unit (r = 0.797-0.917; all P < 0.0001) and in high-throughput settings (r = 0.871; P < 0.0001). The degree of agreement between instruments was moderate to good (κ = 0.52-0.77). In contrast, there was a very poor agreement (κ = -0.14) for total calcium with discrepancy in 53.4% of the samples.

Conclusions: The new ISE Module E1200 is comparable with the ABL835 flex and KoneLab 30i and therefore may be used for routine analysis of serum adjusted Ca2+ (at pH 7.4). The measured adjusted Ca2+ (at pH 7.4) was less comparable with very poor agreement to total calcium measured on the Dimension Vista 1500 system.

Keywords: Actual ionized calcium (at actual pH); adjusted ionized calcium (at pH 7.4); albumin-adjusted calcium; automation; ionized calcium; serum; total calcium.

Publication types

  • Comparative Study
  • Observational Study

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Blood Chemical Analysis / instrumentation*
  • Calcium / blood*
  • Calcium / metabolism
  • Calcium Metabolism Disorders / blood
  • Calcium Metabolism Disorders / diagnosis*
  • Calcium Metabolism Disorders / metabolism
  • Cations, Divalent / blood
  • Child
  • Child, Preschool
  • Female
  • High-Throughput Screening Assays / instrumentation*
  • Humans
  • Hydrogen-Ion Concentration
  • Ion-Selective Electrodes
  • Male
  • Middle Aged
  • Young Adult

Substances

  • Cations, Divalent
  • Calcium