Evaluation of a Novel Array-Based Toxoplasma, Rubella, Cytomegalovirus, and Herpes Simplex Virus IgG Enzyme Linked Immunosorbent Assay and Its Comparison with Virion/Serion Enzyme Linked Immunosorbent Assays

BACKGROUND The dramatic increase in use of the IgG test for toxoplasma, rubella, cytomegalovirus (CMV), and herpes simplex virus (HSV) [TORCH] has led to the requirement for a high-efficiency method that can be used in the clinical laboratory. This study aimed to compare the results of BGI-Array ELISA TORCH IgG (BGI-GBI, China) screening method to those of Virion/Serion TORCH IgG ELISA (Virion/Serion, Germany). METHODS Serum specimens (n=400) submitted for routine IgG testing by Virion/Serion ELISA were also tested using the BGI-Array ELISA method. The agreements of these two kinds of method were analyzed by κ-coefficients calculation. RESULTS Following repeat testing, the BGI-Array ELISA TORCH IgG assays demonstrated agreements of 99.5% (398/400 specimens), 98% (392/400 specimens), 99% (396/400 specimens), and 99.5% (398/400 specimens), respectively. The BGI-Array ELISA IgG assays provided results comparable to Virion/Serion ELISA results, with κ-coefficients showing near-perfect agreement for the HSV (κ=0.87), rubella (κ=0.92) and CMV (κ=0.93) and substantial agreement for the toxoplasma (κ=0.80) IgG assays. The use of the BGI-Array ELISA TORCH IgG assays could reduce the turnaround time (1.5 hr vs. 5 hr by Virion/Serion ELISA for 100 specimens) and were easy to use. CONCLUSIONS BGI-Array ELISA TORCH IgG shows a good agreement with Virion/Serion ELISA methods and is suitable for clinical application.