Lab Med Online.  2020 Jul;10(3):197-201. 10.3343/lmo.2020.10.3.197.

Performance Evaluation of Serum IgD Quantification by the SPAPLUS Turbidimetric Analyzer and Determination of a Reference Interval of IgD in the Korean Population

• Cho EH
• Park HK
• Park HD

• KMID: 2504128
• DOI: http://doi.org/10.3343/lmo.2020.10.3.197

Abstract

Background
IgD is an immunoglobulin isotype that accounts for <1% of the total serum immunoglobulin, and IgD level changes can be observed in specific clinical situations. Herein, we evaluated the analytical performances of serum IgD quantification by the SPAPLUS turbidimetric analyzer (The Binding Site, UK), and determined a reference interval of IgD in the Korean population.
Methods
Precision, linearity and comparison with BNII (Siemens Healthineers, Germany) were assessed, and a reference interval was established according to the Clinical and Laboratory Standards Institute guidelines.
Results
Repeatability ranged from 0.78% to 2.14%, and the within-laboratory precision ranged from 4.10% to 5.40% for three concentrations. The coefficient of determination (R²) was 0.9996 for the analytical measurement range. The IgD concentration showed a correlation between SPAPLUS and BNII (y=0.890x-1.852, r=0.984). However, IgD concentrations tended to be lower in SPAPLUS compared to those in BNII at concentrations >100 mg/L. The established upper limit of the reference interval was 53.6 mg/L.
Conclusions
The SPAPLUS shows good analytical performance for serum IgD quantification.

Keyword

Analytical performance; IgD; Monoclonal gammopathy; Reference interval; Turbidimetry

Figure

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  Fig. 1 Linearity of the SPAPLUS in serum IgD quantification. Linearity was observed within the tested concentration range (0.6–20.8 mg/L) with a coefficient of determination (R2) of 0.9996.

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  Fig. 2 Bland-Altman plots of serum IgD concentrations for comparison of the SPAPLUS and BNII. The IgD concentration showed a significant difference between the SPAPLUS and BNII (P<0.0001). The solid line is the mean difference, the dashed line is the limit of agreement, and the dotted line is the zero difference.

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  Fig. 3 Scatter diagram and Passing-Bablok regression line of serum IgD concentration for comparison of the SPAPLUS and BNII. The solid line is the regression line, the dotted line is the confidence interval, and the gray line is the identity line.

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  Fig. 4 Histogram of IgD concentration from 120 healthy individuals.

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