An automated chemiluminescent immunoassay (CLIA) detects SARS-CoV-2 neutralizing antibody levels in COVID-19 patients and vaccinees

Liu, Binjian; Su, Xibin; Yu, George; Yang, Shu Yuan; Wang, Rui; Huang, Tao; Zhou, Liuyong; Hui, Zhiqiang; Liao, Yixian; Qiu, Yuan; Huang, Juan; Gao, Hong; Liu, Justin; Zhong, Yaoqi

doi:10.1016/j.ijid.2021.12.316

Cited by 20 publications

(21 citation statements)

References 19 publications

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“…The combination of IgG and IgM detection is crucial in the diagnosis of COVID-19. In addition, the CLIA also provides the possibility to replace the conventional standard method in the monitoring of the immune effect of vaccines ( 20 , 21 ). CLIA was primarily used in our study to detect changes in various antibody levels after inactivated vaccine inoculation.…”

Section: Discussionmentioning

confidence: 99%

Investigation of Antibody Levels During Three Doses of Sinopharm/BBIBP Vaccine Inoculation

Cheng

Xue

et al. 2022

Front. Immunol.

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Levels of neutralizing antibodies (NAb) after vaccine against coronavirus disease 2019 (COVID-19) can be detected using a variety of methods. A critical challenge is how to apply simple and accurate methods to assess vaccine effect. In a population inoculated with three doses of the inactivated Sinopharm/BBIBP vaccine, we assessed the performance of chemiluminescent immunoassay (CLIA) in its implementation to detect severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) specific antibodies, as well as the antibody kinetics of healthcare workers throughout the course of vaccination. The antibody levels of NAb, the receptor-binding-domain (RBD) antibodies and IgG peaked one month after the second and remained at a relatively high level for over three months after the booster injection, while IgM and IgA levels remained consistently low throughout the course of vaccination. The production of high-level neutralizing antibodies is more likely when the inoculation interval between the first two doses is within the range of one to two months, and that between the first and booster dose is within 230 days. CLIA showed excellent consistency and correlation between NAb, RBD, and IgG antibodies with the cytopathic effect (CPE) conventional virus neutralization test (VNT). Receiver operating characteristic (ROC) analysis revealed that the optimal cut-off levels of NAb, RBD and IgG were 61.77 AU/ml, 37.86 AU/ml and 4.64 AU/ml, with sensitivity of 0.833, 0.796 and 0.944, and specificity of 0.768, 0.750 and 0.625, respectively, which can be utilized as reliable indicators of COVID-19 vaccination immunity detection.

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Section: Discussionmentioning

confidence: 99%

Investigation of Antibody Levels During Three Doses of Sinopharm/BBIBP Vaccine Inoculation

Cheng

Xue

et al. 2022

Front. Immunol.

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“…Usually, the timing of requests for serological assays and the interpretation of antibody results are pre-requisites of crucial importance in their efficacy [ 118 ]. Combining with chemiluminescence and the immunoreactions, chemiluminescent immunoassay (CLIA) can quantitatively determine the concentrations of corresponding antigens or antibodies through the intensity of luminescence with high sensitivity and specificity [ 119 ]. Based on automatic platforms, CLIA enables high throughput detection, making an outstanding contribution to the early screening.…”

Section: Detection Mechanism Of Sars-cov-2mentioning

confidence: 99%

Micro/nano biomedical devices for point-of-care diagnosis of infectious respiratory diseases

Wang

Dong

et al. 2022

Medicine in Novel Technology and Devices

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Corona Virus Disease 2019 (COVID-19) has developed into a global pandemic in the last two years, causing significant impacts on our daily life in many countries. Rapid and accurate detection of COVID-19 is of great importance to both treatments and pandemic management. Till now, a variety of point-of-care testing (POCT) approaches devices, including nucleic acid-based test and immunological detection, have been developed and some of them has been rapidly ruled out for clinical diagnosis of COVID-19 due to the requirement of mass testing. In this review, we provide a summary and commentary on the methods and biomedical devices innovated or renovated for the quick and early diagnosis of COVID-19. In particular, some of micro and nano devices with miniaturized structures, showing outstanding analytical performances such as ultra-sensitivity, rapidness, accuracy and low cost, are discussed in this paper. We also provide our insights on the further implementation of biomedical devices using advanced micro and nano technologies to meet the demand of point-of-care diagnosis and home testing to facilitate pandemic management. In general, our paper provides a comprehensive overview of the latest advances on the POCT device for diagnosis of COVID-19, which may provide insightful knowledge for researcher to further develop novel diagnostic technologies for rapid and on-site detection of pathogens including SARS-CoV-2.

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“…Serological assays are of critical importance to define previous exposure to SARS-CoV-2 and the prevalence of COVID-19 in populations, evaluate the susceptibility or resistance to subsequent reinfection, identify highly reactive human donors for convalescent plasma therapy, and investigate the correlation of protection obtained through natural infection or vaccination (Tantuoyir and Rezaei 2021 ). In addition, serological assays provide the testing algorithms to indicate the presence of protective antibodies, which cannot be accessed by nucleic acid tests (Castillo-Olivares et al 2021 ; GeurtsvanKessel et al 2020 ; Liu et al 2021 ; Patil et al 2021 ; Tang et al 2020 ).…”

Section: Introductionmentioning

confidence: 99%

Simultaneous detection of antibody responses to multiple SARS-CoV-2 antigens by a Western blot serological assay

Hsiao

Chiang

Chao

et al. 2022

Appl Microbiol Biotechnol

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The nucleic acid test is still the standard assessment for the diagnosis of coronavirus disease 2019 (COVID-19), which is caused by human infection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In addition to supporting the confirmation of disease cases, serological assays are used for the analysis of antibody status and epidemiological surveys. In this study, a single Western blot strip (WBS) coated with multiple Escherichia coli ( E. coli )-expressed SARS-CoV-2 antigens was developed for comprehensive studies of antibody profiles in COVID-19 patient sera. The levels of specific antibodies directed to SARS-CoV-2 spike (S), S2, and nucleocapsid (N) proteins were gradually increased with the same tendency as the disease progressed after hospitalization. The signal readouts of S, S2, and N revealed by the multi-antigen-coated WBS (mWBS)-based serological assay (mWBS assay) also demonstrated a positive correlation with the SARS-CoV-2 neutralizing potency of the sera measured by the plaque reduction neutralization test (PRNT) assays. Surprisingly, the detection signals against the unstructured receptor-binding domain (RBD) purified from E. coli inclusion bodies were not observed, although the COVID-19 patient sera exhibited strong neutralizing potency in the PRNT assays, suggesting that the RBD-specific antibodies in patient sera mostly recognize the conformational epitopes. Furthermore, the mWBS assay identified a unique and major antigenic epitope at the residues 1148, 1149, 1152, 1155, and 1156 located within the 1127–1167 fragment of the S2 subunit, which was specifically recognized by the COVID-19 patient serum. The mWBS assay can be finished within 14–16 min by using the automatic platform of Western blotting by thin-film direct coating with suction (TDCS WB). Collectively, the mWBS assay can be applied for the analysis of antibody responses, prediction of the protective antibody status, and identification of the specific epitope. Key points • A Western blot strip (WBS) coated with multiple SARS-CoV-2 antigens was developed for the serological assay. • The multi-antigen-coated WBS (mWBS) can be utilized for the simultaneous detection of antibody responses to multiple SARS-CoV-2 antigens. • The mWBS-based serological assay (mWBS assay) identified a unique epitope recognized by the COVID-19 patient serum.

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An automated chemiluminescent immunoassay (CLIA) detects SARS-CoV-2 neutralizing antibody levels in COVID-19 patients and vaccinees

Cited by 20 publications

References 19 publications

Investigation of Antibody Levels During Three Doses of Sinopharm/BBIBP Vaccine Inoculation

Investigation of Antibody Levels During Three Doses of Sinopharm/BBIBP Vaccine Inoculation

Micro/nano biomedical devices for point-of-care diagnosis of infectious respiratory diseases

Simultaneous detection of antibody responses to multiple SARS-CoV-2 antigens by a Western blot serological assay

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