Beckman Coulter, Inc.

Biomerieux, Inc.

Dade Behring Inc.

Dade International Inc.

Liliana M Tejidor

Diana B Careaga

Robert T Magari

Timothy J Fischer

Trevor Baglin

Fernando P Chaves

Jianfang Wang

Hema Doobay

Kevin Bruce Johnson

Nicole Carpio

Sanghyuk Shin

Pratap Singh

Colin Downey

Cheng Hock Toh

Roger Luddington

Mike Neisheim

James Maynard

Gregory Jones

Pamela L Hawkins

Mohamad Hasan

Mike Nesheim

John A Samis

Cheng-Hock Toh

John B Walker

Embodiments of the present disclosure may allow for an efficient and accurate way or system to assess whether an individual has sepsis, including an individual who may exhibit symptoms or clinical criteria similar to inflammation. Embodiments include using a laboratory test that may be routinely ordered. Embodiments of the present invention may allow for the diagnosis of sepsis even when some cells show an abnormal size. Often, when white blood cells show a likelihood of an abnormal size, a 'blast flag' in a system is triggered to warn a user that the sample may warrant further analysis. Unexpectedly, the diagnosis of sepsis status using standard deviation of monocyte volume may be more accurate when considering whether a blast flag has been triggered. Based on the sepsis status, treatment may be started quickly, thereby preventing complications, including organ failure and death, of not treating sepsis fast enough.

Method of determining sepsis in the presence of blast flagging

Embodiments may include an automated method for evaluating an infection status associated with a blood sample obtained from an individual. Methods may include determining, using a first module, a white blood cell concentration associated with the blood sample. In addition, methods may include determining, using a second module, a monocyte volume measure associated with the blood sample. Methods may include evaluating, using a data processing module, the infection status associated with the blood sample. The data processing module may include a processor and a computer readable medium. The computer readable medium may be programmed with a computer application. This computer application, when executed by the processor, may cause the processor to calculate a parameter using a function comprising the white blood cell concentration and the monocyte volume measure. The computer application may also cause the processor to evaluate the infection status associated with the blood sample based on the parameter.

Infection detection and differentiation systems and methods

Systems and methods for characterizing immune response to infection using cellular analysis, such as a hematological cellular analyzer. In some instances, the immune response may be characterized as normal or abnormal based on one or more blood cell population parameters. In some instances, abnormal characterization may be used to identify patients with sepsis or at elevated risk of developing sepsis.

Systems and methods for evaluating immune response to infection via monitoring cell granularity parameter of cells

Using vital sign measurements, such as systolic blood pressure (SBP), when combined with hematology parameters such as White Blood Cell Count (WBC) and Monocyte Distribution Width (MDW), has been identified as an improved method for detecting sepsis. The probability of having or developing sepsis is determined when each measurement is compared to a predetermined criteria and the combination of measurements that are within a reference range determines this probability.

Method of detecting sepsis using vital signs, including systolic blood pressure, hematology parameters, and combinations thereof

Systems and methods for using cell granularitry in evaluating immune response to infection

Embodiments may include an automated method for evaluating a sepsis status associated with a blood sample obtained from an individual. Methods may include determining a standard deviation of monocyte volume associated with the blood sample. Methods may include determining a white blood cell count (WBC) associated with the blood sample. Methods may include evaluating, using a data processing module, the sepsis status associated with the blood sample. The data processing module may include a processor and a computer application. This computer application may cause the processor to compare the standard deviation of monocyte volume with a first cutoff value to provide a comparison. The computer application may cause the processor to compare the WBC to a second cutoff to provide a second comparison. The computer application may also cause the processor to evaluate the sepsis status associated with the blood sample based on the first comparison and the second comparison.

Sepsis infection determination systems and methods

A method for diagnosing and monitoring subjects for hemostatic dysfunction, severe infection and systematic inflammatory response syndrome is provided whereby lipoproteins are examined for abnormalities, particularly for prothrominase enhancement, through quantitative and qualitative analysis.

Method for diagnosing and monitoring hemostatic dysfunction, severe infection and systematic inflammatory response syndrome

A method for diagnosing a condition of a patient involves the steps of (a) adding one or more reagents to a test sample from a patient, the test samples comprising at least part of a blood sample from the patient, in order to cause formation of a complex comprising at least one acute phase protein and at least one human lipoprotein, while causing substantially no fiber polymerization; (b) measuring the formation of the complex over time so as to derive a time-dependent measurement profile, and (c) determining a slope and/or total change in the time-dependent measurement profile, so as to diagnose a condition of the patient. A greater formation of the complex is correlated to increased probability of death of the patient.

Method for detecting a lipoprotein-acute phase protein complex and predicting an increased risk of system failure or mortality

A method for assessing coagulation in a test sample is provided wherein an activator is added to a test sample in an amount sufficient to trigger a thrombin explosion dependent on propagation phase and amplification pathways but said amount insufficient to result in complete fibrin polymerization, followed by measuring the amount of fibrin polymerization due to the thrombin explosion and assessing the patient's coagulation based on the measurement of the fibrin polymerization. The method also provides a means for detecting defects in the propagation and amplification phases of coagulation.

Method for assessing coagulation

A method is disclosed for determining if a patient is hypercoagulable, hypocoagulable or normal. The test involves providing a test sample from the patient and initiating coagulation in the sample in the presence of an activator, which is added to the sample in an amount which will result in intrinsic tenase-dependent fibrin. Then the formation of the intrinsic tenase-dependent fibrin polymerization is monitored over time so as to derive a time-dependent profile, with the results of the fibrin polymerization monitoring determining whether the patient is hypercoagulable, normal or hypocoagulable. The coagulation activator is added in an amount that triggers a thrombin explosion that is dependent on the propagation phase and amplification pathways. In this way, a single assay can assess the hemostatic potential of a sample.

Method of determining global coagulability hemostatic potential

The present application relates to a method of making liposomes having membrane proteins incorporated therein, the method comprising: providing the membrane protein in solution; providing a solution of preformed liposomes; and incubating the mixture. Prior to the step of providing a solution of preformed liposomes, the liposomes are formed by combining a mixture of phospholipids with a solution of at least one type of unsaturated fatty acid. The methods of the present invention further relate to the method of making a reagent comprising tissue factor reconstituted into preformed liposomes. The method of the present invention for making a tissue factor reagent comprises: providing tissue factor in solution; providing a solution of preformed liposomes comprising a mixture of phospholipids and at least one type of unsaturated fatty acid; and incubating the mixture.

Reconstitution of purified membrane proteins into preformed liposomes

A reagent and kit are disclosed for determining if a patient is hypercoagulable, hypocoagulable or normal. The test involves providing a test sample from the patient and initiating coagulation in the sample in the presence of an activator, which is added to the sample in an amount which will result in intrinsic tenase-dependent fibrin. Then the formation of the intrinsic tenase-dependent fibrin polymerization is monitored over time so as to derive a time-dependent profile, with the results of the fibrin polymerization monitoring determining whether the patient is hypercoagulable, normal or hypocoagulable. The coagulation activator is added in an amount that triggers a thrombin explosion that is dependent on the propagation phase and amplification pathways. In this way, a single assay can assess the hemostatic potential of a sample.

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Coral Gables, FL, United States of America

Liliana M Tejidor