Becton Dickinson and Company Limited

Keith Edward Thornton

Sha-Sha Wang

William A Nussbaumer

James G Nadeau

Tobin J Hellyer

Danielle Koffenberger

Paul Madepogu

Richard L Moore

Robert W Rosenstein

James A Garrett

Dolores M Berger

William E Keating

Craig C Whiteford

Andrew Kuhn

Sha Sha Wang

Methods for predicting the development of sepsis in a subject at risk for developing sepsis are provided. In one method, features in a biomarker profile of the subject are evaluated. The subject is likely to develop sepsis if these features satisfy a particular value set. Methods for predicting the development of a stage of sepsis in a subject at risk for developing a stage of sepsis are provided. In one method, a plurality of features in a biomarker profile of the subject is evaluated. The subject is likely to have the stage of sepsis if these feature values satisfy a particular value set. Methods of diagnosing sepsis in a subject are provided. In one such method, a plurality of features in a biomarker profile of the subject is evaluated. The subject is likely to develop sepsis when the plurality of features satisfies a particular value set.

Diagnosis of sepsis

Methods and compositions for detection ofare disclosed herein. In some embodiments, the presence or absence ofin a sample is determined using nucleic acid-based testing methods using primers and/or probes that bind to opcA gene region of

Detection of

Nucleic acids sequences that can be used for nucleic acid amplification, for example quantitative nucleic acid amplification, are provided herein.

Internal control nucleic acids for amplification

Detection of neisseria gonorrhoeaes

A high-sensitivity, low-background immuno-amplification assay is provided, which offers a streamlined workflow suitable for high-throughput assays of clinically relevant samples, such as blood and other bodily fluids. The assay comprises the use of two proximity members that each comprise an analyte-specific binding component conjugated to an oligonucleotide. Binding an analyte brings the oligonucleotide moieties of the proximity members in sufficiently close contact that the oligonucleotides form an amplicon. The presence of the analyte then is detected through amplification of the amplicon and detection of the amplified nucleic acids. The sensitivity of the assay of the present invention is improved by preventing spurious or non-specific amplicon formation by proximity members that are not complexed with an analyte.

Immuno-amplification

The invention employs an unlabeled signal primer comprising a 5' adapter sequence for detection of variations in nucleic acid target sequences. The detection system further comprises a reporter probe, the 3&#x2032; end of which hybridizes to the complement of the 5&#x2032; adapter sequence of the signal primer to produce a 5&#x2032; overhang. Polymerase is used to fill in the overhang and synthesize the complement of the 5&#x2032; overhang of the reporter probe. Synthesis of the reporter probe complement is detected, either directly or indirectly, as an indication of the presence of the target.

Methods for detecting nucleic acid sequence variations

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Owings Mills, MD, United States of America

Keith Edward Thornton