Hyaluronic Acid Assays: Turbidimetric or Enzyme-Based Immune Assay? A Method Comparison Study

Abstract

Backgroud: Hyaluronic acid (HA) is proposed as a marker of functional liver capacity. The aim of the present study was to compare a new turbidimetric assay for measuring HA with the current standard method. Methods: HA was measured by a particle-enhanced turbidimetric immunoassay (PETIA) and enzyme-linked immunosorbent assay (ELISA) in a 40-sample dilution series and 39 intensive care unit (ICU) patients. Agreement was assessed with Bland–Altman's method. Results: In the ICU patients, the median HA concentration was 159.0 ng/ml (interquartile range (IQR) 117.5–362.5 ng/ml) with ELISA and 157.5 ng/ml (IQR 92.5–359.6 ng/ml) with PETIA. The mean difference was 12.88 ng/ml (95% CI, −4.3 to 30.1 ng/ml, P = 0.14) and the 95% limits of agreement were −91.17 to 116.9 ng/ml. In the dilution series, the mean difference was −59.26 ng/ml (95% CI, −74.68 to 43.84 ng/ml, P < 0.0001) and the 95% limits of agreement were 35.23 to −153.8 ng/ml. Conclusion: We found random variation between the PETIA and ELISA test that could affect performance in a clinical context, but only to a lesser extent in a research context. The new clinical biochemistry assay for HA determination will allow for large studies of the clinical utility of HA.