Bio-rad Laboratories, Inc.

David L King

William F Link

Renato B Del Rosario

Randy Sweet

Michael Leos

Steven R Binder

The present disclosure provides compositions and methods that are useful for normalizing the amount of signal detected in an assay, such as an immunoassay. The compositions and methods are useful for improving the accuracy of immunoassays, such as immunoassays that detect whether a subject is infected with a retrovirus such as HIV.

Human factor XIII as a normalization control for immunoassays

An anti-antibody reagent for use in a competitive or sandwich simplex or multiplex assay, said reagent comprising one or more labeled anti-antibodies for the primary antibodies to be determined in the assay, the reagent further comprising a corresponding unlabeled anti-antibody in an excess or near excess concentration with respect to their binding partners.

Anti-antibody reagent

Bodily fluid is analyzed for the presence of drugs of a selected panel of drugs in a simultaneous assay in which sample of the fluid is incubated with additional amounts of all drugs of the panel, antibodies specific to each of the drugs of the panel, and microparticles, the microparticles being divided into subsets, one subset for each drug in the panel and each subset distinguishable from the others. The incubation is performed in a liquid medium in which competitive binding occurs, the drugs in the sample competing with those added to the assay medium for binding to the antibodies. In one procedure, the added drugs are pre-coupled to the microparticles while the antibodies are not, and the incubation is followed by further incubating the microparticles with labeled ligands that have affinity for the antibodies. In an alternative procedure, the added drugs are not coupled to the microparticles but are pre-labeled, while the antibodies are pre-coupled to the microparticles, and the assay proceeds without further incubation. In both alternatives, the microparticles are ultimately recovered from the assay medium and from any unbound species, and the recovered microparticles are analyzed by flow cytometry to obtain indications of the presence of the various drugs in the sample in an inverse manner by detection of the label, each drug differentiable from the others by the distinguishing features of the microparticles.

Simultaneous assay for determining drugs

Biological samples are analyzed for benzodiazepines in a single isocratic analysis using a chromatographic column system containing an immobilized enzyme reactor which cleaves glucuronic acid-conjugated benzodiazepines, an anion exchange column, a hydrophobic cation exchange column and a reverse-phase analytical column. Preferred methods of performing the analysis further involve the use of a hydrophobic cation exchange precolumn prior to the anion exchange column. The system readily lends itself to automation, automatic periodic sampling and benzodiazepine identification and quantification. The system is particularly well adapted to the determination and identification of benzodiazepines in urine samples.

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Benicia, CA, United States of America

David L King