Biomarkers for sepsis

a sepsis biomarker and sepsis technology, applied in the field of diagnosis, can solve the problems of increasing the difficulty in devising a diagnostic test, consuming a lot of time, and consuming the culturing of some microorganisms,

Inactive Publication Date: 2005-09-08
LILLY RES LAB A DIV OF ELI LILLY & CO +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0011] In one embodiment of the invention a method of diagnosing sepsis in a human subject is provide. Concentration of at least one analyte in a test sample from a human subject is compared to concentration of the at least one analyte in a reference range that was determined for one or more control samples obtained from one or more human subjects not suf...

Problems solved by technology

Culturing some microorganisms can be tedious and time-consuming, and may provide a high rate of false negatives.
Infection at many different sites can result in sepsis.
The heterogeneity of sepsis increases the difficulty in devising a diagnostic test.
Care of patients with sepsis is expensive and accounts for $17 billion annually in the United States alone.
Sepsis is often lethal, killing 20 to 50 percent of severely affected patients.
Furthermore, sepsis substantially reduces the quality of life of those who su...

Method used

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Examples

Experimental program
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example 1

Materials and Methods for the Experimental Results Described in Example 2

Microarray Manufacture

[0066] Glass slides were cleaned and derivatized with 3-cyanopropyltriethoxysilane. The slides were equipped with a Teflon mask, which divided the slide into sixteen 0.65 cm diameter wells or circular analysis sites called subarrays (FIG. 11). Printing was accomplished with a Perkin-Elmer SpotArray Enterprise non-contact arrayer equipped with piezoelectric tips, which dispense a droplet (˜350 pL) for each microarray spot. Antibodies were applied at a concentration of 0.5 mg / mL at defined positions.

[0067] Each chip was printed with sixteen copies of one type of array, either Array 1.1.1, 2.1.1, 3.1.1, or 4.1. A set of cytokines was printed with quadruplicate spots in each subarray. After printing, chips were inspected using light microscopy. If the percentage of missing spots observed was greater than 5%, then the batch failed and the slides were discarded immediately. For all print run...

example 2

Candidate Biomarkers for Sepsis

[0073] Analyte levels from sepsis patients were compared with normal individuals to identify candidate biomarkers for sepsis. Candidate biomarkers for sepsis were posited to be manifest as a difference in blood analyte levels between time zero sepsis patients and normal controls and that trended toward the normal control value at day 7 in the surviving sepsis patients, in whom sepsis was presumably resolving. For ease of comparison, data were plotted 4 different ways for both serum and citrate plasma samples.

[0074] Of 107 analytes analyzed, six (6%) exhibited interesting differences between the sepsis patients at time zero and normal controls, and that decreased over time, including IL-8, IL-6, IL2sRα, MMP-7, MIPF-1 and IGFBP-1. A brief description for each of the analyte is provided below.

[0075] Since the value of correlation coefficient is very sensitive to outliers and multimode distributions of data, our interpretation is very conservative.

[007...

example 3

Materials and Methods for Results Described in Example 4

Microarray Manufacture

[0090] Glass slides were cleaned and derivatized with 3-cyanopropyltriethoxysilane. The slides were equipped with a Teflon mask, which divided the slide into sixteen 0.65 cm diameter wells or circular analysis sites called subarrays (FIG. 14). Printing was accomplished with a Perkin-Elmer SpotArray Enterprise non-contact arrayer equipped with piezoelectric tips, which dispense a droplet (˜350 pL) for each microarray spot. Antibodies were applied at a concentration of 0.5 mg / mL at defined positions.

[0091] Each chip was printed with sixteen copies of one type of array, i.e. Array 5. A set of cytokines was printed with quadruplicate spots in each subarray. After printing, chips were inspected using light microscopy. If the percentage of missing spots observed was greater than 5%, then the batch failed and the slides were discarded immediately. For all print runs described herein, 100% of the antibody feat...

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Abstract

Biomarkers for sepsis and resulting mortality can be detected by assaying blood samples. Changes in the concentration of the biomarkers can be used to indicate sepsis, risk of sepsis, progression of sepsis, remission from sepsis, and risk of mortality. Changes can be evaluated relative to data sets, natural or synthetic or semisynthetic control samples, or patient samples collected at different time points. Some biomarkers' concentrations are elevated during disease and some are depressed. These are termed informative biomarkers. Some biomarkers are diagnostic in combination with others. Individual biomarkers may be weighted when used in combinations. Biomarkers can be assessed in individual, isolated or assays, in parallel assays, or in single-pot assays.

Description

TECHNICAL FIELD OF THE INVENTION [0001] This invention is related to the area of diagnosis. In particular, it relates to diagnosis, risk assessment, and monitoring of sepsis. BACKGROUND OF THE INVENTION [0002] Sepsis is the name given to infection when symptoms of inflammatory response are present. Of patients hospitalized in an intensive care unit (ICU) who have an infection, 82% have sepsis. Sepsis is defined as an infection-induced syndrome involving two or more of the following features of systemic inflammation: fever or hypothermia, leukocytosis or leukopenia, tachycardia, and tachypnea or a supranormal minute ventilation. Sepsis may be defined by the presence of any of the following ICD-9-CM codes: 038 (septicemia), 020.0 (septicemic), 790.7 (bacteremia), 117.9 (disseminated fungal infection), 112.5 (disseminated Candida infection), and 112.81 (disseminated fungal endocarditis). [0003] Sepsis is diagnosed either by clinical criteria or by culture of microorganisms from the blo...

Claims

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Application Information

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IPC IPC(8): G01N33/53G01N33/537G01N33/543
CPCG01N2800/26G01N33/6893
Inventor KINGSMORE, STEPHEN F.LEJNINE, SERGUEI J.DRISCOLL, MARKTCHERNEV, VELIZAR T.
Owner LILLY RES LAB A DIV OF ELI LILLY & CO
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