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| LEADER |
02875nam a2200673Ia 4500 |
| 001 |
10.4155-bio-2020-0308 |
| 008 |
220427s2021 CNT 000 0 und d |
| 020 |
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|a 17576180 (ISSN)
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| 245 |
1 |
0 |
|a Assay concept for detecting anti-drug IgM in human serum samples by using a novel recombinant human IgM positive control
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| 260 |
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0 |
|b Future Medicine Ltd.
|c 2021
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| 856 |
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|z View Fulltext in Publisher
|u https://doi.org/10.4155/bio-2020-0308
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| 520 |
3 |
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|a Aim: Development and qualification of an easy-to-use ELISA for detection of IgM anti-drug antibodies (ADA) and its use in a clinical Phase I trial. Results & methodology: During the assay development two positive control (PC) approaches, the preparation of a chemically conjugated and a recombinant PC, were pursued. With both PCs, the assay was developed and successfully qualified considering the regulatory guidelines. For a case study, the IgM ADA isotyping assay with the recombinant PC was selected. Different courses and intensities of immune response regarding IgM signals were demonstrated. Conclusion: The easy-to-use ELISA allowed IgM-ADA detection in clinical samples. Conjugated and recombinant IgM PCs were comparable regarding assay sensitivity, precision and suitability. © 2021 Roche Diagnostics GmbH.
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| 650 |
0 |
4 |
|a ADA isotyping
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| 650 |
0 |
4 |
|a Antibodies, Anti-Idiotypic
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| 650 |
0 |
4 |
|a antibody detection
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| 650 |
0 |
4 |
|a antiidiotypic antibody
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| 650 |
0 |
4 |
|a anti-IgM
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| 650 |
0 |
4 |
|a Article
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| 650 |
0 |
4 |
|a biological therapy
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| 650 |
0 |
4 |
|a Biological Therapy
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| 650 |
0 |
4 |
|a biotherapeutics
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| 650 |
0 |
4 |
|a blood
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| 650 |
0 |
4 |
|a blood sampling
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| 650 |
0 |
4 |
|a conjugation
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| 650 |
0 |
4 |
|a controlled study
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| 650 |
0 |
4 |
|a drug antibody
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| 650 |
0 |
4 |
|a enzyme linked immunosorbent assay
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| 650 |
0 |
4 |
|a Enzyme-Linked Immunosorbent Assay
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| 650 |
0 |
4 |
|a HEK293 cell line
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| 650 |
0 |
4 |
|a human
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| 650 |
0 |
4 |
|a human cell
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| 650 |
0 |
4 |
|a Humans
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| 650 |
0 |
4 |
|a IgM positive control
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| 650 |
0 |
4 |
|a immune response
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| 650 |
0 |
4 |
|a immune response characterization
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| 650 |
0 |
4 |
|a immunocytokine
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| 650 |
0 |
4 |
|a immunogenicity
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| 650 |
0 |
4 |
|a immunoglobulin E
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| 650 |
0 |
4 |
|a immunoglobulin G1
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| 650 |
0 |
4 |
|a immunoglobulin G3
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| 650 |
0 |
4 |
|a immunoglobulin G4
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| 650 |
0 |
4 |
|a immunoglobulin M
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| 650 |
0 |
4 |
|a malignant neoplasm
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| 650 |
0 |
4 |
|a measurement accuracy
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| 650 |
0 |
4 |
|a phase 1 clinical trial (topic)
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| 650 |
0 |
4 |
|a polymerase chain reaction
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| 650 |
0 |
4 |
|a practice guideline
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| 650 |
0 |
4 |
|a procedures
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| 650 |
0 |
4 |
|a qualitative analysis
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| 650 |
0 |
4 |
|a sensitivity and specificity
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| 650 |
0 |
4 |
|a signal transduction
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| 650 |
0 |
4 |
|a targeted immunocytokine
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| 700 |
1 |
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|a Abdolzade-Bavil, A.
|e author
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| 700 |
1 |
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|a Engel, A.M.
|e author
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| 700 |
1 |
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|a Künzel, C.
|e author
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| 700 |
1 |
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|a Pleitner, M.
|e author
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| 700 |
1 |
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|a Schick, E.
|e author
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| 700 |
1 |
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|a Stubenrauch, K.
|e author
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| 773 |
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|t Bioanalysis
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