Evaluation of human IgG subclass assays on Beckman array

Automated immunonephelometric assays were developed to measure human IgG subclasses in serum, on the Beckman Array Protein System (APSR), with sheep antihuman IgG subclass antisera. The interassay imprecision was judged to be satisfactory in each case (CV: IgG1: 2.3%; IgG2: 2.9%; IgG3: 4.0% and IgG4 5.4%). The standard curves were found to be linear in the ranges 1.5-30.0 g/L for IgG1, 1.5-15.0 g/L for IgG2, 0.1-1.0 g/L for IgG3 and 0.1-1.0 g/L for IgG4. The lower limit for quantification of the immunephelometric assays was 0.5 g/L for IgG1, 0.04 g/L for IgG2, 0.06 g/L for IgG3 and 0.03 g/L for IgG4. We found no antigen excess to at least 60.0 g/L for IgG1 and IgG2, 3.5 g/L for IgG3 and 2.0 g/L for IgG4. Nephelometric results correlated with those of radial immunodiffusion (r = 0.96 for IgG1, r = 0.93 for IgG2, r = 0.90 for IgG3 and r = 0.96 for IgG4). The reaction monitored by the Beckman Array Protein System is easy to perform, rapid and precise. The performance makes the immunonephelometric method suitable for the determination of IgG subclass concentrations in routine analysis.