Comparative study of erythrocyte sedimentation rate measurement between Celltac Alpha+ (MEK-1305) ESR Analyzer and standard Westergren method
Article Sidebar
Main Article Content
Abstract
Background: The Westergren method, a gold standard method for erythrocyte sedimentation rate (ESR) measurement, is one of the screening tests for routine clinical hematology that can be used as an inflammation marker. Since the results can be altered by numerous factors, new methodologies have been established to manage the possible pitfalls.
Objective: This study compared erythrocyte sedimentation rate measurements obtained by the Celltac Alpha+ (MEK-1305) Automated Hematology and ESR analyzer with those obtained by the standard Westergren method.
Materials and methods: The Celltac Alpha+ (MEK-1305) Automated Hematology and ESR analyzer was used to assess the performance of ESR measurement compared to the standard Westergren method. A total of 220 random EDTA whole blood samples from patients were included and analyzed in parallel using the automated analyzer and the standard Westergren method.
Results: Spearman’s rank correlation coefficient (ρ = 0.916) obtained a good correlation between the two methods. In addition, the precision was good and acceptable according to the criteria, with a %CV of less than 10% in both intra-run and inter-run precision. There was no contamination between blood samples from using a single capillary probe. Moreover, Bland-Altman mean difference plot also indicated a good agreement, with a mean bias of -1.4 (95% CI: -0.8 to 2.1), an upper LOA of 7.6 (95% CI: 6.6 to 8.7) and a lower LOA = -10.5 (95% CI: -11.6 to -9.5).
Conclusion: This comparative study indicated that the Celltac Alpha+ (MEK-1305) Automated Hematology and ESR analyzer is applicable within clinical routine practice along with proper measurement regulation. Even though the principles between these two methods are completely different, an acceptable interrelation was obtained due to the calibration process by Nihon Kohden corporation.
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Personal views expressed by the contributors in their articles are not necessarily those of the Journal of Associated Medical Sciences, Faculty of Associated Medical Sciences, Chiang Mai University.
References
ICSH recommendations for measurement of erythrocyte sedimentation rate. International Council for Standardization in Haematology (Expert Panel on Blood Rheology). J Clin Pathol. 1993; 46(3): 198-203. doi: 10.1136/jcp.46.3.198
Brigden ML. Clinical utility of the erythrocyte sedimentation rate. Am Fam Physician. 1999; 60: 1443-50. PMID: 10524488
Piva E, Pajola R, Temporin V, Plebani M. A new turbidimetric standard to improve the quality assurance of the erythrocyte sedimentation rate measurement. Clin Biochem. 2007; 40: 491-5. doi: 10.1016/j.clinbiochem.2006.12.002.
Kernick D, Jay AW, Rowlands S. Erythrocyte settling. Can J Physiol Pharmacol. 1974; 52(6): 1167-77. doi: 10.1139/y74-152
Zhao TX, Jacobson B. Quantitative correlations among fibrinogen concentration, sedimentation rate and electrical impedance of blood. Med Biol Eng Comput. 1997; 35(3): 181-5. doi: 10.1007/BF02530035
Holley L, Woodland N, Hung WT, Cordatos K, Reuben A. Influence of fibrinogen and haematocrit on erythrocyte sedimentation kinetics. Biorheology. 1999; 36(4): 287-97. PMID: 10690265.
Oka S. A physical theory of erythrocyte sedimentation. Biorheology. 1985; 22(4): 315-21. doi: 10.3233/bir-1985-22404
Operator’s Manual of Celltac α+ Automated Hematology and ESR Analyzer Nihon Kohden, Japan.
Kratz A, Plebani M, Peng M, Lee YK, McCafferty R, Machin SJ. ICSH recommendations for modified and alternate methods measuring the erythrocyte sedimentation rate. Int J Lab Hematol. 2017; 39(5): 448- 57. doi: 10.1111/ijlh.12693.
Clinical and Laboratory Standards Institute (CLSI). Measurement Procedure Comparison and Bias Estimation Using Patient Samples, Approved Guideline, 3rd. Ed. EP09-A3rd. Wayne, PA: CLSI; 2018.
Clinical and Laboratory Standards Institute (CLSI). Evaluation of detection capability for clinical laboratory measurement procedures. Approved Guideline, 2nd Ed. EP17-A2. Wayne, PA: CLSI; 2012.
Clinical and Laboratory Standards Institute (CLSI). Validation and Quality Assurance of Automated Hematology Analyzers. Approved Standard, 2nd Ed. H26-A2. Wayne, PA: CLSI; 2010.
Kahar MA. Comparison of alternate erythrocyte sedimentation rate measurement by automated Celltac α+ (MEK 1305) and reference Westergren method. J Hematol Allied Sci. 2022; 2: 39-45. doi: 10.25259/JHAS_12_2022.
Cha C, Cha YJ, Park C, Kim H, Cha E, Kim DH, et al. Erythrocyte sedimentation rate measurements by TEST 1 better reflect inflammation than do those by the Westergren method in patients with malignancy, autoimmune disease, or infection. Am J Clin Pathol. 2009; 131(2): 189-94. doi: 10.1309/AJCP0U1ASTLRANIJ.
Boğdaycioğlu N, Yilmaz FM, Sezer S, Oğuz E. Comparison of iSED and Ves-Matic Cube 200 Erythrocyte Sedimentation Rate Measurements With Westergren Method. J Clin Lab Anal. 2015; 29(5): 397-404. doi: 10.1002/jcla.21786.
Lapić I, Piva E, Spolaore F, Tosato F, Pelloso M, Plebani M. Automated measurement of the erythrocyte sedimentation rate: method validation and comparison. Clin Chem Lab Med. 2019; 57(9): 1364-73. doi: 10.1515/cclm-2019-0204.
Plebani M, Piva E. Erythrocyte sedimentation rate: use of fresh blood for quality control. Am J Clin Pathol. 2002; 117(4): 621-6. doi: 10.1309/QB1G- 6FRR-DNWX-BKQ9.
Mahlangu JN, Davids M. Three-way comparison of methods for the measurement of the erythrocyte sedimentation rate. J Clin Lab Anal. 2008; 22: 346-52. doi: 10.1002/jcla.20267.
Horsti J, Rontu R, Collings A. A comparison between the StaRRsed auto-compact erythrocyte sedimentation rate instrument and the westergren method. J Clin Med Res. 2010; 2: 261-5. doi: 10.4021/jocmr476w.
Schapkaitz E, RabuRabu S, Engelbrecht M. Differences in erythrocyte sedimentation rates using a modified Westergren method and an alternate method. J Clin Lab Anal. 2019; 33: e22661. doi: 10.1002/jcla.22661.
Ryosuke M, Yoko T, Yamamoto T, Hiroyuki T, Tomohiro S, Esaki T, et al. Accuracy study of a novel alternate method measuring erythrocyte sedimentation rate for prototype hematology analyzer Celltac α+. Int J Lab Hematol. 2021; 43: 588-96. doi: 10.1111/ijlh.13554.