Development of IgM-ELISA for diagnosis of recent infection of Japanese encephalitis virus in equines

Sahu, Anamika; Dhanze, Himani; Singh, Vijayta; Mehta, Deepa; Gupta, Megha; Singh, Mithilesh; Vinod, Valil Kunjukunju; Gulati, Baldev R.

doi:10.1016/j.biologicals.2022.01.001

Cited by 3 publications

(1 citation statement)

References 11 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In these guidelines, new terms, such as ATP, risk assessment, CMA, analytical procedure parameters, MODR, and enhanced models, are explained in a scientific and standardized manner. ELISA is one of the most commonly used analytical biochemistry assays to quantify levels of a specific target within a sample [ 34 , 35 , 36 , 37 ]. During the development of the ELISA method described here, the modern methodological system theory of detection was applied.…”

Section: Discussionmentioning

confidence: 99%

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Han

An²,

Liu³

et al. 2022

Viruses

View full text Add to dashboard Cite

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) protein subunit vaccine is one of the mainstream technology platforms for the development of COVID-19 vaccines, and most R&D units use the receptor-binding domain (RBD) or spike (S) protein as the main target antigen. The complexity of vaccine design, sequence, and expression systems makes it urgent to establish common antigen assays to facilitate vaccine development. In this study, we report the development of a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to determine the antigen content of SARS-CoV-2 protein subunit vaccines based on the United States Pharmacopeia <1220> and ICH (international conference on harmonization) Q14 and Q2 (R2) requirements. A monoclonal antibody (mAb), 20D8, was identified as the detection antibody based on its high RBD binding activity (EC50 = 8.4 ng/mL), broad-spectrum anti-variant neutralizing activity (EC50: 2.7–9.8 ng/mL for pseudovirus and EC50: 9.6–127 ng/mL for authentic virus), good in vivo protection, and a recognized linear RBD epitope (369–379 aa). A porcine anti-RBD polyclonal antibody was selected as the coating antibody. Assay performance met the requirements of the analytical target profile with an accuracy and precision of ≥90% and adequate specificity. Within the specification range of 70–143%, the method capability index was >0.96; the misjudgment probability was <0.39%. The method successfully detected SARS-CoV-2 protein subunit vaccine antigens (RBD or S protein sequences in Alpha, Beta, Gamma, or Delta variants) obtained from five different manufacturers. Thus, we present a new robust, reliable, and general method for measuring the antigenic content of SARS-CoV-2 protein subunit vaccines. In addition to currently marketed and emergency vaccines, it is suitable for vaccines in development containing antigens derived from pre-Omicron mutant strains.

show abstract

Section: Discussionmentioning

confidence: 99%

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Han

An²,

Liu³

et al. 2022

Viruses

View full text Add to dashboard Cite

show abstract

A one-tube rapid visual CRISPR assay for the field detection of Japanese encephalitis virus

Gong

Zhang

et al. 2022

Virus Research

View full text Add to dashboard Cite

Development of a blocking ELISA for detection of Japanese encephalitis virus antibodies in pig and horse sera

Yang,

Kim,

Jang

et al. 2024

Korean J Vet Res

View full text Add to dashboard Cite

Japanese encephalitis virus (JEV) is a mosquito-borne virus that can infect pigs, horses, and other mammals, including humans. Sero-epidemiological investigations of JEV have been performed using hemagglutination inhibition (HI), virus neutralization (VN) tests and enzyme-linked immunosorbent assay (ELISA). A need exists for a new ELISA that can detect JEV antibodies in the sera of several animal species. We aimed to develop a blocking ELISA (B-ELISA) for detecting JEV antibodies in pig and horse serum samples. JEV antibodies in 218 pig and 315 horse serum samples were measured using HI and VN tests. The purified KV1899-306 strain was used as an antigen for B-ELISA. The purified antibody (7A13) was conjugated with horseradish peroxidase and used as a detector antibody. The sera of pigs and horses to measure antibody against JEV were subjected to B-ELISA and analyzed. The B-ELISA had a diagnostic sensitivity of 94.6% to 100%, a specificity of 91.2 to 100%, and an accuracy of 94.9 to 98.6% compared with those of the HI and VN tests in pig and horse sera. The B-ELISA had a higher correlation with pig sera (r = 0.89 and 0.90 for VN and HI) than with horse sera (r = 0.75 and to 0.79). The new B-ELISA could be useful in the sero-surveillance of JEV in pig and horse sera and replace indirect ELISA.

show abstract

Development of IgM-ELISA for diagnosis of recent infection of Japanese encephalitis virus in equines

Cited by 3 publications

References 11 publications

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

Development of an ELISA Assay for the Determination of SARS-CoV-2 Protein Subunit Vaccine Antigen Content

A one-tube rapid visual CRISPR assay for the field detection of Japanese encephalitis virus

Development of a blocking ELISA for detection of Japanese encephalitis virus antibodies in pig and horse sera

Contact Info

Product

Resources

About