Thu. Jul 7th, 2022


Conventional IgG assays require expensive equipment and trained experts. Semi-quantitative measurement of total IgG using point-of-care testing devices may be the solution to these limitations. This study evaluated the reproducibility of the ImmuneCheck ™ IgG Assay (ProteomeTech Inc., Korea) and the correlation of its results with conventional laboratory serum and whole blood IgG results.

Expected use

  • Real-time monitoring of human IgG content based on immunochromatography technique
  • In vitro diagnostic use


Both serum and whole blood samples from 120 patients were used. To assess intra-test reproducibility and inter-test correlation, intraclass correlation coefficient (ICC) analysis was used.


Total serum IgG concentration measured by cobas® 6000 (Roche Diagnostics, Switzerland) ranged from 690.4 to 2756.4 mg / dL. The intratest reproducibility of ImmuneCheck ™ IgG was high (serum ICC = 0.724, P <0.001; whole blood ICC = 0.843, P <0.001). The inter-assay correlation between ImmuneCheck ™ IgG and cobas® 6000 results was very good (serum ICC = 0.805, P <0.001; whole blood ICC = 0.842, P <0.001).

Since there were no samples with a total IgG level less than 600 mg / dL, the pre-existing serum samples were diluted and then linearity tests were performed. Intratest reproducibility for diluted serum samples was near perfect (ICC = 0.995, P <0.001), and the inter-assay correlation between ImmuneCheck ™ IgG and cobas® 6000 results was also strong (ICC = 0.992, P <0.001) .


The ImmuneCheck ™ IgG assay is reproducible and highly correlated with the conventional IgG assay for serum and whole blood. It could be applied for the rapid detection of total IgG.

Keywords: POCT total IgG; Rapid semi-quantification; Total IgG Assay