Ortho Diagnostic Systems Inc.

Ortho-clinical Diagnostics, Inc

Other

Ortho Pharmaceutical Corporation

Chander Bahl

Leopoldo G Mendoza

Richard L Egan

James Phillip Galvin

Frank J McMahon

Antonio Samson

Rhonda Lang

Denise Madjor

Patrick Niven

The present invention describes peptides and recombinant proteins containing Hepatitis C virus core protein sequence in which one or more of the amino acids have been modified or deleted to remove the ability of these proteins to bind to specific anti-HCV murine monoclonal antibodies. The deletions and modifications are designed as to maintain the ability of this protein to be used in immunoassays used for the detection of anti-HCV antibodies in individuals infected with HCV.

HCV core protein sequences

Monoclonal antibodies that specifically bind to HCV core antigen. Also provided are hybridoma cell lines which secrete these antibodies, methods for making and using these antibodies, including kits that include these antibodies.

HCV anti-core monoclonal antibodies

Described herein is an ELISA based assay for the detection of HCV infection. This new assay can detect HCV infection earlier than the currently used assays for the screening of blood for HCV infection by using a combination of HCV antigens and anti-core antibodies to capture HCV.

Hepatitis C antigen&mdash;antibody combination assay for the early detection of infection

Methods of chemical synthesis of labeled nucleotide probes are described. The methods comprise providing a first target recognition moiety comprising a nucleotide sequence of at least about 15 nucleotide bases including at least one 5' end and 3' end. The first target recognition moiety is chemically altered to contain a carboxyl group. A second signal generating moiety comprising a hydroxyl group is provided. The carboxyl group of the first target recognition moiety is chemically reacted with hydroxyl group of the second signal generating moiety to chemically join the two moieties and produce said labeled nucleotide probe.

Chemical preparation of high specific activity nucleotide probes

This reagent strip is comprised of a testing portion which contains an absorbent cotton pad. This absorbent cotton pad may be placed in the mouth on the tongue to collect an oral fluid sample. A plastic frame surrounds the pad to help hold the fluid thereon. This testing strip contains at its opposite end a sealing mechanism for sealing engagement with a preservative pouch, and an oversized handle with a patient identifying mechanism. The preservative pouch of the present invention contains a pair of seals. The first seal, located proximally to the user, enables a preservative which is maintained within the pouch to be sealed during shipment of the pouch to the user. Thereafter, the user punctures the first seal upon placement of the reagent pad into the pouch. The sealing mechanism contained on the reagent pad then seals at the opening in the pouch to maintain the reagent pad in sealing arrangement within the pouch. At its distal end, the pouch contains a second sealing mechanism. This sealing mechanism helps protect the preservative as well as the oral sample, within the pouch during shipment from the user back to the testing laboratory.

In home oral fluid sample collection device and package for mailing of

The present invention provides labeled nucleotide probes and a procedure for synthesis of the labeled nucleotide probe by a coupling or joinder of two components of the probe, namely a target recognition sequence moiety and a signal generating moiety, through the use of a bridging complement that holds the two moieties in such a position as to allow formation of a sugar-phosphate chemical linkage between the 3' end of one moiety and the 5' end of the other moiety.

Method of preparing nucleotide probes using a bridging complement

The probes of the invention are made up of a target recognition moiety and a signal generation moiety. In the first step of the preparatory method of the invention, the 5' or 3' terminus or both of the target recognition moiety is chemically altered to incorporate a reactive functionality which will allow chemical linkage of this target recognition moiety with one or both termini of the signal generation moiety of the probe. Suitable functionalities vary widely, but may, in general be described as those that allow chemical attachment of the two moieties either at the 5' or 3' end of the target recognition moiety. The two moieties should not detach from each other upon hybridization of the target moiety to the target analyte. Thus, when the probe is hybridized to target analyte, it will then carry with it, signal moiety, to label this complex, which label is then later detected.

High specific activity nucleotide probes having target recognition and

High specific activity nucleic acid probes having target recognition and

Methods of immobilizing nucleic acid on a solid surface for us in nucleic acid hybridization assays is disclosed. The methods of the invention comprise reacting a modified nucleic acid strand comprising a variable portion and an anchor portion wherein the variable portion comprises a nucleotide sequence having a selected base sequence and the anchor portion comprises at least one nucleotide base modified with a primary amine function or nucleotide base equivalent having a primary amine function and reacting the modified nucleic acid strand with a free aldehyde group of the solid surface in the presence of a reducing agent to form complexes of the modified nucleic acid strand and at least a portion of the free aldehyde groups on the solid surface.

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Flemington, NJ, United States of America

Chander Bahl