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
Affiliations
- Medica Medizinische Laboratorien Dr. F. Kaeppeli AG, Zurich, Switzerland.
- Division of Clinical Chemistry and Biochemistry, Children's Research Center, University Children's Hospital Zurich, University of Zurich, Switzerland.
- Division of Hematology, Children's Research Center, University Children's Hospital Zurich, University of Zurich, Switzerland.
- 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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