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Clin Biochem. 2021 Nov 23; doi: 10.1016/j.clinbiochem.2021.11.010. Epub 2021 Nov 23.

Using the hemolysis index of Abbott's Alinity c for the measurement of plasma free hemoglobin in ECMO patients.

Clinical biochemistry

Carmen Bürki, Martin Volleberg, David Brunner, Markus Schmugge, Martin Hersberger

Affiliations

  1. Medica Medizinische Laboratorien Dr. F. Kaeppeli AG, Zurich, Switzerland.
  2. Division of Clinical Chemistry and Biochemistry, Children's Research Center, University Children's Hospital Zurich, University of Zurich, Switzerland.
  3. Division of Hematology, Children's Research Center, University Children's Hospital Zurich, University of Zurich, Switzerland.
  4. Division of Clinical Chemistry and Biochemistry, Children's Research Center, University Children's Hospital Zurich, University of Zurich, Switzerland. Electronic address: [email protected].

PMID: 34826395 DOI: 10.1016/j.clinbiochem.2021.11.010

Abstract

OBJECTIVES: Quantitative measurement of plasma free hemoglobin (fHb) concentrations is essential for monitoring pediatric ECMO patients, since hemolysis has a great impact on the patient's clinical outcome. The aim of this study was to validate the hemolysis index (HI) assay on Abbott's Alinity c system as a quantitative method to measure fHb.

METHODS: The performance of the HI assay, based on an automated spectrophotometric method recording the absorption at four different wavelength pairs, was evaluated using the 20 × 2 × 2 design according to the CLSI-EP05-A3 guidelines. LLOQ and LLOD were calculated according to CLSI-EP17 guidelines with CVs set to 10% and 20%, respectively. Furthermore, the method was tested for interferences with bilirubin and Intralipid®.

RESULTS: Linearity was ensured over an analytical measurement range of 30-7250 mg/L and the calculated LLOQ and LLOD were 80 mg/L and 50 mg/L, respectively. Intra-run and total imprecisions ranged from 0.9-3.4% and 1.0-3.4%, respectively. The HI assay correlated well with the Harboe method (HI (mg/L) = 0.998 * fHb (mg/L) + 28 mg/L, R = 0.998, n = 50) and interference testing showed no impact of bilirubin and Intralipid® up to 709 mg/L and 5580 mg/L, respectively.

CONCLUSIONS: The HI assay on Abbott's Alinity c system allows a precise and accurate determination of fHb concentrations with no significant interferences in a simple, rapid and cost-effective way.

Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.

Keywords: ECMO; Hemolysis Index; Interference; Method comparison; Plasma free hemoglobin; Precision profile

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