Detecting microbial infection in wounds
Inventors
GUSE, Jan Hinrich • Reisser, Martin • Pietrzik, Nikolas • Baeuerlein, Christiane • Eitel, Kornelia
Assignees
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Publication Number
US-12265082-B2
Publication Date
2025-04-01
Expiration Date
Abstract
The disclosed technology relates to chemical entities for the detection of wounds, e.g., chronic wounds or infected wounds, including compositions, substrates, kits, dressing materials, and articles, and systems containing such compounds. The disclosed technology further relates to methods of using these compositions, kits and systems in diagnostic assays, and in the diagnosis and/or detection of chronic or infected wounds based on enzymatic action on specific moieties and/or reaction sites. The disclosed technology additionally relates to detection of pathogenic, e.g., bacterial and/or viral substances, such as enzymes and substrates, at the wound situs. Additional disclosure relates to methods of characterizing wounds based on expression of a plurality of markers and using such information to treat, manage, and follow-up patients suffering from chronic or infected wounds.
Core Innovation
The invention provides a chemical entity defined by Formula I comprising an anchor (A), an enzyme recognition site (R), and an indicator region (I). The enzyme recognition site (R) comprises at least one enzyme-labile region or enzyme-reactive region, and the anchor (A) enables binding of the chemical entity to a support material. The indicator region (I) provides a detectable output associated with the enzyme recognition function.
For detection of enzyme activity from a body fluid, the Formula I chemical construct is configured so that the enzyme recognition site (R) comprises a site for protease or a site for elastase. The enzyme recognition site (R) includes amino acid sequence architectures of the form Xy-AAPXy-Z, Xy-AAPXy-L-Z, Xy-AAP(V/F/A)Xy-Z, or Xy-AAP(V/F/A)Xy-L-Z, where each X is any amino acid, y is an integer from 1 to 50, L is a linking moiety, and Z is a label.
The indicator region (I) is defined to include a dye containing a sulfonylethyl-hydrogensulphate-reactive-group or a dye containing a dichlortriazine reactive-group, or a detectable label selected from luminescent and chemiluminescent molecules, fluorochromes, fluorescent quenching agents, colored molecules, radioisotopes, scintillants, biotin, avidin, streptavidin, antibodies or fragments thereof, polyhistidine, Ni2+, epitope tags, heavy metals, and enzymes. The disclosure further describes multiplex configurations by incorporating multiple enzyme recognition sites in one construct.
Claims Coverage
Two independent claims are present. The combined coverage centers on a Formula I chemical entity with anchor, enzyme recognition site, and indicator region, and on a body-fluid detection reagent that further limits the recognition site to protease or elastase sequence patterns and the indicator region to specific dye chemistries or a defined set of detectable labels.
Formula I chemical entity with anchor, enzyme recognition site, and indicator region
A chemical entity comprising a compound of Formula I where A is an anchor, R is an enzyme recognition site, and I is an indicator region; R comprises at least one enzyme-labile region or enzyme-reactive region; and A enables binding of the chemical entity to a support material.
Body-fluid enzyme activity detection reagent with protease or elastase sequence patterns
A chemical for detection of enzyme activity from a body fluid comprising a compound of Formula I where A is an anchor enabling binding to a support material, R comprises at least one enzyme-labile region or enzyme-reactive region and comprises a site for protease or a site for elastase, and R comprises an amino acid sequence architecture Xy-AAPXy-Z, Xy-AAPXy-L-Z, Xy-AAP(V/F/A)Xy-Z, or Xy-AAP(V/F/A)Xy-L-Z with each X any amino acid and y an integer from 1 to 50.
Indicator region with reactive dye groups or selectable detectable labels
I comprises a dye containing a sulfonylethyl-hydrogensulphate-reactive-group or a dye containing a dichlortriazine reactive-group, or a detectable label selected from luminescent/chemiluminescent molecules, fluorochromes, fluorescent quenching agents, colored molecules, radioisotopes, scintillants, biotin, avidin, streptavidin, antibodies or fragments thereof, polyhistidine, Ni2+, epitope tags, heavy metals, and enzymes.
The claims collectively cover Formula I constructs that couple an anchor for binding to a support material, an enzyme-labile or enzyme-reactive recognition site, and an indicator region for detection. The body-fluid claim further specifies protease or elastase sequence patterns and the indicator chemistries or detectable label classes.
Stated Advantages
The indicator label remains visually associated, such as persistence of blue label signal.
Label changes are consistent with enzyme-releasable behavior in cleavage or activation cases.
The approach enables enzyme-activity detection.
Documented Applications
Dye-labeled enzyme-recognition constructs and support-bound dye/label formats used for enzyme hydrolysis and cleavage activity characterization involving elastase and cathepsin G.
Testing concept for solid-phase dipsticks and clinical assessment related to enzyme activity.
Medical-device monitoring related to enzyme activity.
Protease detection contexts involving body fluid.
Detection of enzyme activity from a body fluid using a chemical comprising a compound of Formula I.
Use in wound dressings.
Use in diagnostic systems and kits.
Use on surfaces, including microarrays.
Use in tubes or aspiration systems.
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