Bio-rad Laboratories, Inc.

Steven R Binder

Jodi L Goodrich

Zara Safarian

Michael I Watkins

Ravi Kaul

David L King

John Flanagan

Michelle Delanoy

Audrey Arjomandi

Caroline Scolari

Robert K Likuski

Tony Prestigiacomo

Woei Tan

Aleksander Raskin

Bryan H Ikeda

Tan Woei

The present invention relates to an immunoassay for the detection ofspecific IgG, IgM and IgG/IgM antibodies in biological samples suspected of Lyme infection. The immunoassay can be performed via a standard immunoassay format or on an automated platform. In various embodiments, the immunoassay uses one or morespecific chimeric peptides VlsE-FlaB (designated pFlaB-mV), VlsE-ErpP (designated pErp59-mV), VlsE-P35 (designated pP35-mV) alone or in combination with one or more outer surface protein C (Osp C) types B or I, p58 and DbpA. Other aspects of the invention provide antigen/substrate combinations and compositions comprising combinations of the disclosed peptides and/or proteins for use in the immunoassays described herein.

immunoassays and materials therefor

The present invention provides methods and reagents for detecting anti-phospholipid-cofactor protein-antibodies.

Solid phase immobilization of phospholipids and cofactor proteins via covalent attachment

Analyses of serum samples for the presence and amount of either of the two subunits of human Factor XIII protein are used as a means of eliminating a significant source of error that arises in the testing of serum and plasma. For serum samples, a negative result of an analysis for the presence of subunit a is a means of verifying that a sample is indeed serum, while a negative or positive result for subunit a serves to distinguish serum (negative) from plasma (positive). A positive result for the presence of subunit b is a means of verifying that the sample is either serum or plasma and not any other biological fluid. A quantitative analysis of subunit b is a means of verifying that the sample is of the intended volume rather than having been reduced in volume due to improper sampling. A quantitative analysis of subunit b is also a means of verifying the dilution of a sample of either serum or plasma.

FXIII detection for verifying serum sample and sample size and for detecting dilution

Water-soluble polymer is added to the liquid phase in a heterogeneous a immunoassay of serum, the polymer having monomers in common with monomers of the solid phase surface. This reduces non-specific binding of IgG's from the serum to the solid phase surface and thereby reduces the occurrence of false positive readings in the immunoassay.

Reducing non-specific binding in immunoassays performed on polymeric solid phases

The present invention is generally directed to the analysis of biological samples. More particularly, the present invention is directed to automated sample analysis for paraproteins using immunosubtraction, capillary electrophoresis and Fourier transformation analysis.

Computer directed identification of paraproteins

Identification and quantification of paraproteins in a sample is achieved by Fourier analysis of mobility-based electropherograms obtained from capillary electrophoresis. The use of a computer algorithm to analyze capillary electrophoresis data, provides the clinician with methods of detecting levels of paraproteins in serum as low as 0.05 g/dL. Additionally, an individual paraprotein can be located on an electropherogram and used to monitor its increased or decreased production in an individual.

Computer-directed detection of paraproteins

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.

System for benzodiazepine detection

Biological fluid test samples are analyzed for a broad spectrum of drugs, including benzodiazepines, amphetamines, tricyclic antidepressants and opiates, in a single isocratic analysis using a chromatographic column system containing three analytical columns--an anion exchange column, a reversed phase column and a cation exchange column. A pre-column is also included to purge the sample of salts, proteins, peptides and hydrophilic anions. Carrier liquids containing acetonitrile at various strengths are used for distribution of the various drugs among the columns, elution of the drugs from the columns, and column purging and conditioning. The system readily lends itself to automation, automatic periodic sampling, and component identification and quantification.

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Berkeley, CA, United States of America

Steven R Binder