Korean J Lab Med.  2007 Dec;27(6):414-419. 10.3343/kjlm.2007.27.6.414.

Evaluation of Two Beta2-microglobulin Reagents by Turbidimetric Immunoassay

• Park KS
• Kang SY
• Lee WI

• KMID: 1781545
• DOI: http://doi.org/10.3343/kjlm.2007.27.6.414

Abstract

BACKGROUND: An increased level of beta2-microglobulin (beta2M) 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 beta2M assay for precision and linearity using an automated turbidimetric immunoassay (TIA) by Hitachi 7600-110 (Hitachi High Technologies Co., Japan). The TIA of beta2M 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, betweendays 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 beta2M.

Keyword

Beta2-microglobulin; Turbidimetric immunoassay; Chemiluminescent immunoassay

MeSH Terms

Aged
Chemiluminescent Measurements
Enzyme Multiplied Immunoassay Technique
Female
Humans
Immunoassay/*methods
Male
Middle Aged
Nephelometry and Turbidimetry
Reagent Kits, Diagnostic
Regression Analysis
Sensitivity and Specificity
beta 2-Microglobulin/*analysis

Figure

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  Fig. 1. Linearity of concentrations of beta2-microglobulin analyzed by Hitachi 7600-110. (A) Roche-TIA. (B) HBI-TIA.

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  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.

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