Biomaterial Database

A sensitive immunoradiometric assay for the quantification of murine monoclonal antibodies in human serum. 1989

J M Apathy, and R R Bowsher

Drug Disposition Research Department, Lilly Laboratory for Clinical Research, Eli Lilly and Company, Indianapolis, IN 46202.

The clinical investigation of murine monoclonal antibodies (MoAbs) as potential immunotherapeutic agents necessitates their quantification in human serum. The present paper reports the development of a sensitive, non-competitive "sandwich" immunoradiometric assay specifically optimized for measurement of murine IgG in human serum. Affinity-purified goat anti-mouse IgG antibody covalently bound to acrylic microspheres serves as the solid-phase antibody and 125I-labelled goat anti-mouse IgG antibody functions as tracer. All assay reagents were obtained from commercial sources. The assay is sensitive (capable of detecting 20 ng ml-1 of murine IgG), specific (less than 0.0001% cross-reactivity with human IgG), reproducible (intra-assay % RSD less than 6.3%), and rapid (a 100-tube assay can routinely be processed in 3 h). The assay has a working concentration range of 20-2000 ng ml-1 and is suitable for measuring MoAbs of any antigenic specificity. The assay was validated for use with human serum and cell culture media by comparison studies with flow cytometric and immunonephelometric methods and by high-performance size-exclusion chromatographic studies. Application of this assay should facilitate further investigation of murine MoAbs as potential immunotherapeutic agents.

UI	MeSH Term	Description	Entries
D007074	Immunoglobulin G	The major immunoglobulin isotype class in normal human serum. There are several isotype subclasses of IgG, for example, IgG1, IgG2A, and IgG2B.	Gamma Globulin, 7S,IgG,IgG Antibody,Allerglobuline,IgG(T),IgG1,IgG2,IgG2A,IgG2B,IgG3,IgG4,Immunoglobulin GT,Polyglobin,7S Gamma Globulin,Antibody, IgG,GT, Immunoglobulin
D001826	Body Fluids	Liquid components of living organisms.	Body Fluid,Fluid, Body,Fluids, Body
D002679	Pan troglodytes	The common chimpanzee, a species of the genus Pan, family HOMINIDAE. It lives in Africa, primarily in the tropical rainforests. There are a number of recognized subspecies.	Chimpanzee,Chimpanzee troglodytes,Chimpanzee troglodyte,Chimpanzees,Pan troglodyte,troglodyte, Pan,troglodytes, Chimpanzee
D003470	Culture Media	Any liquid or solid preparation made specifically for the growth, storage, or transport of microorganisms or other types of cells. The variety of media that exist allow for the culturing of specific microorganisms and cell types, such as differential media, selective media, test media, and defined media. Solid media consist of liquid media that have been solidified with an agent such as AGAR or GELATIN.	Media, Culture
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818	Animals	Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA.	Animal,Metazoa,Animalia
D000911	Antibodies, Monoclonal	Antibodies produced by a single clone of cells.	Monoclonal Antibodies,Monoclonal Antibody,Antibody, Monoclonal
D012680	Sensitivity and Specificity	Binary classification measures to assess test results. Sensitivity or recall rate is the proportion of true positives. Specificity is the probability of correctly determining the absence of a condition. (From Last, Dictionary of Epidemiology, 2d ed)	Specificity,Sensitivity,Specificity and Sensitivity
D015203	Reproducibility of Results	The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.	Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D015592	Immunoradiometric Assay	Form of radioimmunoassay in which excess specific labeled antibody is added directly to the test antigen being measured.	Assay, Immunoradiometric,Assays, Immunoradiometric,Immunoradiometric Assays