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

TY - JOUR

T1 - Hyaluronic Acid Assays

T2 - Turbidimetric or Enzyme-Based Immune Assay? A Method Comparison Study

AU - Itenov, Theis Skovsgaard

AU - Kirkby, Nikolai S

AU - Bestle, Morten H

AU - Nilsson, Anna C

AU - Erlandsen, Erland J

AU - Peters, Lars

AU - Jensen, Jens-Ulrik

N1 - © 2015 Wiley Periodicals, Inc.

PY - 2016/9/1

Y1 - 2016/9/1

N2 - 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.

AB - 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.

U2 - 10.1002/jcla.21897

DO - 10.1002/jcla.21897

M3 - Journal article

C2 - 26667792

SN - 0887-8013

VL - 30

SP - 524

EP - 528

JO - Journal of Clinical Laboratory Analysis

JF - Journal of Clinical Laboratory Analysis

IS - 5

ER -