Becton Dickinson and Company Limited

Gregory Tice

Thomas M Gentle, Jr

Paul Ernest Goldenbaum

Richard L Moore

Song Shi

Robert W Rosenstein

Nicholas Robert Bachur, Jr

James A Garrett

Donald W Copertino

Richard Ivey

Michael L Towns

James G Nadeau

Ming-hsiung Yeh

Mark L Sussman

Gary Siuzdak

Elizabeth J Want

Zhouxin Shen

Timothy M Sullivan

Dolores M Berger

Joseph E Ahnell

H Mark Perks

Stephen G Wilson

The early prediction or diagnosis of sepsis advantageously allows for clinical intervention before the disease rapidly progresses beyond initial stages to the more severe stages, such as severe sepsis or septic shock, which are associated with high mortality. Early prediction or diagnosis is accomplished using a molecular diagnostics approach, involving comparing an individual's profile of biomarker expression to profiles obtained from one or more control, or reference, populations, which may include a population who develops sepsis. Recognition of features in the individual's biomarker profile that are characteristic of the onset of sepsis allows a clinician to diagnose the onset of sepsis from a bodily fluid isolated at the individual at a single point in time. The necessity of monitoring the patient over a period of time is, therefore, avoided, advantageously allowing clinical intervention before the onset of serious symptoms. Further, because the biomarker expression is assayed for its profile, identification of the particular biomarkers is unnecessary. The comparison of an individual's biomarker profile to biomarker profiles of appropriate reference populations likewise can be used to diagnose SIRS in the individual.

Diagnosis of sepsis or SIRS using biomarker profiles

Mass spectrometry techniques for determining the status of sepsis in an individual are provided. A biomarker profile resolved from a biological sample, taken from the individual, using a mass spectrometry technique is compared to a reference biomarker profile. A single such comparison classifies the individual as belonging to or not belonging to a reference population. The individual's biomarker profile and the reference biomarker profile comprise a plurality of ions each having a mass-to-charge ratio of about 100 Daltons to about 1000 Daltons. The plurality of ions can be detected by electrospray ionization mass spectrometry in positive mode. The comparison uses a decision rule, such as a classification tree, that determines the status of sepsis in the individual without requiring knowledge of the identity of the biomarkers in the biomarker profile from the individual and without requiring knowledge of the identity of the biomarkers in the reference biomarker profile.

Mass spectrometry techniques for determining the status of sepsis in an individual

Method of predicting the onset of sepsis in SIRS-positive individuals using mass spectrometry

The present invention relates to a transparent sample container containing, preferably, a liquid bacterial growth media for detecting microbacteria and a process for detecting microbacteria using this sample container. The container is optically transparent, heat resistant, and stable during storage. The container and process provide a bacterial growth medium substantially free of contamination upon prolonged storage of preferably about one year at 40&deg; C.

Method of detecting microorganisms utilizing transparent sample container

Transparent sample container

A carrier having at least one kinetics and fluorescence enhancing support and a dry substance selected from the group consisting of fluorogenic substrates, B methylumbelliferone, 7-amino-4-methyl coumarin, B-napthylamine, fluoroscein, and resorufin deposited on the support demonstrates substantial enhancement of hydrolysis kinetics and fluorescence over pure liquid systems. When the device has a plurality of supports and the supports have different fluorogenic substrates an enzyme rate-of-reaction profile representative of a microorganism in the suspension can be determined and used to identify the organism. The device can also be used to characterize enzymes expressed by other biological specimens.

Device for enhancing fluorescence and kinetics and methods of using the

A non-ionic lytic agent, preferably saponin for reducing the background carbon dioxide produced by blood cell metabolism is used in the testing of cultures for the presence of microorganisms. The hemolytic agent saponin is combined with a phospholipid, preferably L-.alpha.-Lecithin (phosphatidylcholine), to form mixed micelles which protect saponin from the effects of heat sterilization and high blood cholesterol levels, thus maintaining the lytic activity of saponin. The phospholipid/saponin mixed micelles are added to non-radiometric culture media vials such as Bactec.RTM. NR6A, NR7A and NR8A. The media vials are used in the Bactec.RTM. NR-660 and NR-730 instruments. However, the present invention may also be used in radiometric media such as Bactec.RTM. culture vials 6, 7 and 8 for reducing background carbon dioxide levels detected in C.sup.14 radiometric instruments such as the Bactec.RTM.-460, or in other instruments designed to detect bacteria in the presence of mammalian cells by monitoring the increase in CO.sub.2 produced by the metabolizing bacteria.

Method for reducing blood carbon dioxide background in bacterial media

An apparatus and method for the detection of the growth of microorganisms through infrared analysis of a sample of the gas produced by growth of the microorganism is descirbed. In the method, a sample of the headspace gas in a vial containing a growth medium which has been inoculated with a sample suspected of containing a microorganism is removed and transferred to a sample cell where infrared analysis is used to determine the presence of carbon dioxide, if any, produced by the growth of the microorganism.

Method for the detection of biologically active agents

The present invention is directed to a system for locating a vial in a predetermined location with respect to a needle which is used to penetrate a septum in the vial. The system includes a vial carrier having a well for receiving a vial. A penetrable septum is disposed in an opening in the vial. At least one needle penetrates the septum at periodic intervals. Locating means are provided within the vial carrier for establishing a predetermined location of the vial in relation to the needle. The locating means includes a plurality of contact points and urging means for establishing contact between the contact points and the locating surface. The urging means presses substantially on one side of the vial, which side is substantially opposite the locating means.

System for controlling septum damage

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Lutherville, MD, United States of America

Gregory Tice