Assessment of mumps virus-specific antibodies: Comparison of three different enzyme immunoassays and neutralization test.

IF 1.9 4区 医学 Q3 INFECTIOUS DISEASES Journal of Infection and Chemotherapy Pub Date : 2025-02-01 Epub Date: 2024-12-02 DOI:10.1016/j.jiac.2024.11.021
Yuka Mihara, Tetsuo Nakayama, Fumihiko Hattori, Midori Yamada, Tetsushi Yoshikawa
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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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腮腺炎病毒特异性抗体的评估:三种不同酶免疫测定和中和试验的比较。
简介:我们评估了一种新改进的酶免疫测定(EIA)试剂盒,腮腺炎IgG Seiken®,通过比较不同的EIA试剂盒的抗体反应,中和试验(nt),使用临床样品。方法:对128例无流行性腮腺炎史或未接种流行性腮腺炎疫苗的儿童进行接种前和接种后4 ~ 6周的血清采集。使用三种不同的EIA试剂盒,腮腺炎IgG Seiken®(一种来自酶制剂®的商业试剂盒)和一种内部试剂盒,检测腮腺炎特异性IgG抗体。评估每个EIA试剂盒和nt之间的抗腮腺炎抗体反应。结果:接种前,除3份腮腺炎IgG Seiken®血清检测结果模棱两可外,其余血清均为阴性。接种后腮腺炎IgG Seiken®抗体阳性率和模棱两可率(分别为71.1%和23.4%)与酶制剂(分别为74.2%和19.5%)相当。结论:新批准的腮腺炎IgG Seiken®与NTs具有良好的相关性,且与内部试剂盒相比具有较低的模糊率,与enzymatic gnost®相当。该试剂盒可用于临床可接受的疫苗免疫原性评价。
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来源期刊
Journal of Infection and Chemotherapy
Journal of Infection and Chemotherapy INFECTIOUS DISEASES-PHARMACOLOGY & PHARMACY
CiteScore
4.10
自引率
4.50%
发文量
303
审稿时长
47 days
期刊介绍: The Journal of Infection and Chemotherapy (JIC) — official journal of the Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases — welcomes original papers, laboratory or clinical, as well as case reports, notes, committee reports, surveillance and guidelines from all parts of the world on all aspects of chemotherapy, covering the pathogenesis, diagnosis, treatment, and control of infection, including treatment with anticancer drugs. Experimental studies on animal models and pharmacokinetics, and reports on epidemiology and clinical trials are particularly welcome.
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