Evaluation of Two Beta2-microglobulin Reagents by Turbidimetric Immunoassay

Kyung-sun Park; So-Young Kang; Woo-In Lee

doi:10.3343/kjlm.2007.27.6.414

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Park, Kang, and Lee: Evaluation of Two Beta2-microglobulin Reagents by Turbidimetric Immunoassay

Original Article

Korean J Leg Med 2007;27(6):414-419.

Published online: 14 February 2007

DOI: https://doi.org/10.3343/kjlm.2007.27.6.414

Evaluation of Two Beta2-microglobulin Reagents by Turbidimetric Immunoassay

Kyung-sun Park, M.D., So-Young Kang, M.D., Woo-In Lee, M.D.

Department of Laboratory Medicine, Kyung Hee University College of Medicine, Seoul, Korea

Received 26 March 200714 November 2007 Accepted 15 November 2007

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

An increased level of beta2-microglobulin (β2M) is seen in diseases such as lymphoproliferative diseases, renal diseases, solid tumors, liver diseases, certain viral infection, or chronic inflammatory diseases, etc. In this study, we evaluated a quantitative β2M assay for precision and linearity using an automated turbidimetric immunoassay (TIA) by Hitachi 7600-110 (Hitachi High Technologies Co., Japan). The TIA of β2M was compared with a chemiluminescent immunoassay (CLIA) by Immulite 2000 (Diagnostic Products Corporation, USA).

Methods

Two TIAs, the Hitachi 7600-110 with Roche reagent (Roche-TIA) and the Hitachi 7600-110 with HBI reagent (HBI-TIA), were evaluated for within-run precision, within-day precision, between-days precision, and linearity. With 68 serum samples, two TIAs were compared with Immulite 2000 using DPC reagent (DPC-CLIA). These data were analyzed by Passing-Bablok analysis and Bland-Altman analysis.

Results

The coefficients of variation (CVs) of within-run precision, within-day precision, and between-days precision were less than 7% in all groups. The linearity tests of the two TIAs were maintained well (Roche-TIA: R²=0.9952; HBI-TIA: R²=0.9946). The comparison study indicated good correlations (Roche-TIA/DPC-CLIA: r=0.9738, y=0.9625x-0.0375; HBI-TIA/DPC-CLIA: r=0.9725, y=1.1000x-0.3100). In Bland-Altman analysis, less than 2SD differences were observed between the two groups.

Conclusions

Both Roche-TIA and HBI-TIA showed a good precision and excellent correlations with DPC-CLIA; therefore, TIA could be used in the routine laboratory to determine a quantitative analysis of β2M.

Keywords: Beta2-microglobulin, Turbidimetric immunoassay, Chemiluminescent immunoassay

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Fig. 1.

Linearity of concentrations of beta2-microglobulin analyzed by Hitachi 7600-110. (A) Roche-TIA. (B) HBI-TIA.

Fig. 2.

Method comparisons of beta2-microglobulin concentrations from 68 samples. (A, B) Passing-Bablok regression analysis. (A) DPC-CLIA vs Roche-TIA; (B) DPC-CLIA vs HBI-TIA. (C, D) Bland-Altman analysis. (C) DPC-CLIA vs Roche-TIA: mean difference, 0.12 mg/L; (D) DPC-CLIA vs HBI-TIA: mean difference, 0.05 mg/L.

Table 1.

Precision of beta2-microglobulin assay by turbidimetric immunoassay at low and high levels

		Low level (mg/L) Mean 0.90 Range 0.72-1.08		High level (mg/L) Mean 3.00 Range 2.40-3.60
		Roche^∗	HBI^†	Roche^∗	HBI^†
Within-run	Mean (mg/L)	0.85	0.94	2.94	3.43
	SD (mg/L)	0.01	0.05	0.03	0.05
	CV (%)	1.17	5.32	1.02	1.46
Within-day	Mean (mg/L)	0.85	0.91	2.96	3.37
	SD (mg/L)	0.02	0.06	0.03	0.08
	CV (%)	2.04	6.46	1.08	2.34
Between-days	Mean (mg/L)	0.77	0.80	2.80	3.34
	SD (mg/L)	0.04	0.05	0.05	0.10
	CV (%)	4.84	6.42	1.85	2.86
Total CV (%)		5.99	6.56	2.17	2.80

^∗ Turbidimetric immunoassay with Roche reagent;

^† turbidimetric immunoassay with HBI reagent.

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