Analytical validation of the modified Westergren method on the automated erythrocyte sedimentation rate analyzer CUBE 30 touch

Ivana Lapić; Anamarija Rade; Anđela Kraljević; Marija Miloš; Désirée Coen Herak; Lucija Daskijević; Paula Cerovac; Dunja Rogić

doi:10.1515/cclm-2023-0033

Article

Analytical validation of the modified Westergren method on the automated erythrocyte sedimentation rate analyzer CUBE 30 touch

Ivana Lapić , Anamarija Rade , Anđela Kraljević , Marija Miloš , Désirée Coen Herak , Lucija Daskijević , Paula Cerovac and Dunja Rogić

Published/Copyright: February 20, 2023

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From the journal Clinical Chemistry and Laboratory Medicine (CCLM) Volume 61 Issue 8

Abstract

Objectives

Analytical validation of automated erythrocyte sedimentation rate (ESR) analyzers is necessary prior to their implementation into routine practice. Our aim was to perform the analytical validation of the modified Westergren method applied on the CUBE 30 touch analyzer (Diesse, Siena, Italy).

Methods

Validation included determination of within-run and between-run precision following the Clinical and Laboratory Standards Institute EP15-A3 protocol, comparison with the reference Westergren method, sample stability assessment at both room temperature and 4 °C, after 4, 8 and 24-h storage, and checking the extent of hemolysis and lipemia interference.

Results

Coefficients of variation (CVs) for within-run precision were 5.2% for the normal and 2.6% for the abnormal range, while between-run CVs were 9.4 and 2.2%, respectively. Comparison with the Westergren method (n=191) yielded Spearman’s correlation coefficient of 0.93, no constant nor proportional difference [y=0.4 (95% CI: −1.7–1.0) + 1.06 (95% CI: 1.00–1.14)x] and a non-significant mean absolute bias of −2.6 mm (95% CI: −5.3–0.2). Lower comparability was evidenced with increasing ESR values, with both constant and proportional differences for ESR values between 40 and 80 mm, and above 80 mm. Sample stability was not compromised up to 8-h storage both at room temperature (p=0.054) and 4 °C (p=0.421). Hemolysis did not affect ESR measurement up to 1.0 g/L of free hemoglobin (p=0.089), while lipemia index above 5.0 g/L affects the ESR result (p=0.004).

Conclusions

This study proved that CUBE 30 touch provides reliable ESR measurement and satisfactory comparability with the reference Westergren methods, with minor variation related to methodological differences.

Keywords: automation; erythrocyte sedimentation rate; validation study; Westergren method

Corresponding author: Ivana Lapić, Department of Laboratory Diagnostics, University Hospital Centre Zagreb, Kišpatićeva 12, 10000 Zagreb, Croatia, Phone: +385 1 2367288, E-mail: ivana.lapic@hotmail.com

Research funding: None declared.
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Informed consent: Not applicable.
Ethical approval: The local Institutional Review Board deemed the study exempt from review.

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Received: 2023-01-10

Accepted: 2023-02-12

Published Online: 2023-02-20

Published in Print: 2023-07-26

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Articles in the same Issue

https://doi.org/10.1515/cclm-2023-0033

Keywords for this article

automation; erythrocyte sedimentation rate; validation study; Westergren method