Carol Aloisio (CDC)
Charlotte Black (CDC)
Deborah Moore (CDC)
Donald Phillips (CDC)
Gale Galland (CDC)
Thomas Wells (CDC)
Immunoglobulins play a key role in the immune system. CDC has developed and tested hybridoma cell lines (monoclonal antibody (mAb) clones) for human IgG and other immunoglobulins. The mAbs generated from those hybridomas could be used as a reagent (second Ab) of anti-human immunoglobins in a diagnostic assay for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the virus that causes COVID-19 (coronavirus disease 2019) and other assays that detect antigen specific antibodies from human sera.
Collaborating international scientists evaluated the mAbs which showed reactivity and specificity for human IgG (11), the IgG subclasses (59), or Gm allotypes (4) by employing different assay techniques or protocols. These mAbs that can be satisfactorily applied in several diagnostic testing methodologies such as enzyme-linked immunosorbent assay (ELISA), immunofluorescence microscopy, direct hemagglutination and hemagglutination inhibition assays, and more. The hybridomas that produce those mAbs have potential as reference reagents and research tools for investigating infection processes.
- Development or refinement of diagnostic assays for coronavirus and other indications
- Controls or a reference reagent source for diagnostic assay validation
- Quality control/quality assurance testing for coronavirus vaccine or therapeutic development
- Monitoring and public health surveillance
- Research tools
- Potentially speed up product development with CDC-developed materials that have already been tested and validated
- Can apply to multiple diagnostic types such as ELISA, immunofluorescent assays, hemagglutination inhibition assays, and more
- Easily adapted to a high-throughput assay for mass screening purposes