Exploratory study of antibody titers against SARS-CoV-2 using an indirect immunoperoxidase assay in COVID-19 patients and vaccinated volunteers.

IF 3.6 Q1 TROPICAL MEDICINE Tropical Medicine and Health Pub Date : 2024-09-29 DOI:10.1186/s41182-024-00635-y
Shungo Katoh, Ikkoh Yasuda, Kazuhiro Kitakawa, Sugihiro Hamaguchi, Eiichiro Sando
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Abstract

Background: A number of antibody test kits for detecting prior SARS-CoV-2 infection and post-immunization status have been commercialized. Indirect immunoperoxidase assay (IIP) is a conventional method to test antibodies. We evaluated the diagnostic accuracy and antibody titer profile of the IIP in COVID-19 and pre- and post-vaccination.

Methods: We conducted a hospital-based observational study in Fukushima prefecture, Japan. We enrolled COVID-19 inpatients who tested positive by PCR. We used serum samples collected > 10 years before the pandemic as the negative control. We also included volunteers vaccinated at the hospital. All participants were tested using an IIP with whole-cell antigen of the six SARS-CoV-2 variants isolated in Japan during the epidemic and an IgG ELISA kit. Negative controls and vaccinated volunteers were also tested using a lateral flow assay (LFA) kit. We conducted receiver operating characteristic (ROC) analysis to evaluate diagnostic accuracy and performed logistic regression analysis to explore factors associated with antibody titer.

Results: We included 146 COVID-19 inpatients, 38 negative controls, and 36 vaccinated volunteers. Most participants had the highest titer for IgG and IgM in the wild type-A antigen among the six variants. The sensitivity, specificity, and accuracy of the IgG ELISA kit were 60.3%, 100%, and 68.5%; of the IIP for IgG with the cutoff titer at 1:80, 82.2%, 94.7%, and 84.8%, respectively. The ROC curves of the ELISA and IIP for IgG were almost identical. In the IgG tests of the 36 volunteers, 35 were positive for ELISA and IIP and 34 for LFA after two vaccinations. IgM titers in the IIP were <  = 1:40 in 114 patients and 32 volunteers after two vaccinations; therefore, the IgM titer is unsuitable for diagnosis. In COVID-19 patients, age, days from disease onset, >  = 7 days after the second vaccination, and immunosuppressants for comorbidity were associated with IgG titer of >  = 1:640 in the IIP.

Conclusions: The diagnostic accuracy of the IIP for detecting IgG antibodies in COVID-19 or after two vaccinations is equivalent to that of an ELISA. Further investigations are required to address the association between antibody titers in the IIP and their protective or harmful effects against COVID-19.

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使用间接免疫过氧化物酶测定法对 COVID-19 患者和接种过疫苗的志愿者的 SARS-CoV-2 抗体滴度进行探索性研究。
背景:许多用于检测 SARS-CoV-2 既往感染和免疫后状态的抗体检测试剂盒已经商业化。间接免疫过氧化物酶检测法(IIP)是检测抗体的传统方法。我们评估了 COVID-19 和接种疫苗前后 IIP 的诊断准确性和抗体滴度情况:我们在日本福岛县开展了一项基于医院的观察性研究。我们招募了经 PCR 检测呈阳性的 COVID-19 住院患者。我们使用大流行前 10 年采集的血清样本作为阴性对照。我们还纳入了在医院接种疫苗的志愿者。所有参与者都接受了使用日本在疫情期间分离出的六种 SARS-CoV-2 变体全细胞抗原的 IIP 和 IgG ELISA 试剂盒进行的检测。阴性对照组和接种过疫苗的志愿者也使用侧流试验(LFA)试剂盒进行了检测。我们进行了接收器操作特征(ROC)分析以评估诊断准确性,并进行了逻辑回归分析以探讨与抗体滴度相关的因素:我们纳入了 146 名 COVID-19 住院患者、38 名阴性对照和 36 名接种过疫苗的志愿者。在六种变体中,大多数参与者的野生型-A 抗原 IgG 和 IgM 滴度最高。IgG 酶联免疫吸附试剂盒的灵敏度、特异性和准确性分别为 60.3%、100% 和 68.5%;以 1:80 为界限滴度的 IgG 免疫吸附试验的灵敏度、特异性和准确性分别为 82.2%、94.7% 和 84.8%。ELISA 和 IIP 检测 IgG 的 ROC 曲线几乎相同。在对 36 名志愿者进行的 IgG 检测中,有 35 人在接种两次疫苗后,ELISA 和 IIP 检测结果呈阳性,34 人 LFA 检测结果呈阳性。第二次接种后 7 天,IIP 中的 IgM 滴度为 =,因合并症而服用免疫抑制剂与 IIP 中的 IgG 滴度 > = 1:640 相关:结论:IIP检测COVID-19或两次疫苗接种后IgG抗体的诊断准确性与ELISA相当。需要进一步研究 IIP 中的抗体滴度与其对 COVID-19 的保护作用或有害作用之间的关联。
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来源期刊
Tropical Medicine and Health
Tropical Medicine and Health TROPICAL MEDICINE-
CiteScore
7.00
自引率
2.20%
发文量
90
审稿时长
11 weeks
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