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Article Abstract

Introduction: We evaluated the application of a newly improved enzyme immunoassay (EIA) kit, Mumps IgG Seiken®, by comparing antibody responses to different EIA kits, and neutralization tests (NTs), using clinical samples.

Methods: Serum samples were collected before and 4-6 weeks after vaccination from 128 children who had no history of mumps or mumps vaccination. Using three different EIA kits, Mumps IgG Seiken®, a commercial kit from Enzygnost®, and an in-house kit, mumps-specific IgG antibodies were measured. Anti-mumps antibody responses between each of the EIA kits and NTs were evaluated.

Results: Before vaccination, all samples were seronegative, except for three serum samples measured by Mumps IgG Seiken®, which exhibited equivocal. The antibody-positivity rates and equivocal rates of Mumps IgG Seiken® post-vaccination (71.1 % and 23.4 %, respectively) were comparable to those of Enzygnost® (74.2 % and 19.5 %, respectively). However, antibody-positivity and equivocal rates were significantly higher and lower than those of in-house kit (51.6 % and 40.6 %, respectively) (p < 0.05). The concordance rates of the kit (68.7 %) were comparable to those of Enzygnost® (71.1 %) and higher than those of in-house-developed kit (58.6 %) (p < 0.05). The area under curve of the three EIA kits were 0.801, 0.804, and 0.859; however, the differences did not reach significance. Correlations of the values obtained using three EIA kits with NTs were 0.71, 0.61, and 0.78.

Conclusion: The newly approved Mumps IgG Seiken® showed good correlation with NTs and had lower equivocal rates compared to in-house kit, comparable to Enzygnost®. This kit may be clinically acceptable for the evaluation of vaccine immunogenicity.

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http://dx.doi.org/10.1016/j.jiac.2024.11.021DOI Listing

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