Gen-probe, Inc.

Janel M Dockter

Jeffrey M Linnen

Damon Kittredge Getman

Reinhold B Pollner

Daniel Kolk

Martha K Ho-Sing-Loy

Leslie A Stringfellow

Sunghae A Joo

Tadashi Yoshimura

Astrid R W Schroder

Barbara Susan Weinbaum

Daniel P Kolk

Kits for detecting analyte polynucleotides and an internal control in a sample. Included in the kit are an internal control polynucleotide and amplification reagents to co-amplify a first analyte polynucleotide and the internal control. Also included are first and second hybridization probes, each having a label indistinguishable from the other. The probes are respectively capable of hybridizing with a first analyte amplicon and an internal control amplicon. The first and second labels are indistinguishable homogeneous labels.

Kits for single-step analyte detection with process control

Compositions, methods and kits for detecting viral nucleic acids. Targets that can be detected in accordance with the invention include HBV and/or HIV-1 and/or HCV nucleic acids. Particularly described are oligonucleotides that are useful as hybridization probes and amplification primers that facilitate detection of very low levels of HBV nucleic acids.

Compositions and methods for detecting hepatitis B virus

Reaction mixture containing an analyte probe and an internal control probe, where the analyte probe and the internal control probe target different nucleic acids and have labels that generate signals that are indistinguishable from each other.

Reaction mixture containing probes having indistinguishable labels

Oligomers useful for determining the presence ofin a test sample.

Oligonucleotides for use in determining the presence ofin a sample

Apparatus and method for detecting analyte in a reaction mixture comprising an internal control. The invention is illustrated using amplification and detection of nucleic acids, where the amplification reaction comprises an exogenous internal control. Magnitude of the detection signal serves as the variable for identifying invalid trials, identifying valid trials that are negative for analyte, and identifying trials that are positive for analyte. Detection of a signal indicating probe hybridization can be used for assigning the presence or absence of analyte nucleic acid in validated reactions using only a single detectable label, and without distinguishing the proportion of signal contributed by internal control probe binding, and analyte probe binding.

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San Diego, CA, United States of America

Janel M Dockter