Neutralized antibody and method of use thereof
AssigneeFZata, Inc.
InventorsZhiyong Yang, Hua Yu
Life of this patent
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Abstract
Described herein, are methods of detecting neutralizing antibodies that bind to Clostridioides difficile (C. diff) toxin B (TcdB), prognosing the disease severity of Clostridioides difficile infection (CDI) and the risk of primary and recurrent CDI, as well as providing a guide for clinical practice. Also described herein are kits for performing the methods of this disclosure.
Claims19
A method of detecting antibodies that bind to Clostridioides difficile (C. diff) toxin B (TcdB) in a biological sample, comprising:
- (a) contacting a substrate to which TcdB is attached with (i) a biological sample and (ii) a labeled antibody that binds to TcdB,
- (b) washing the substrate, and
- (c) detecting a signal from the labeled antibody, wherein the amount of the signal detected is inversely correlated to the amount of antibodies that binds to TcdB in the sample;
- wherein the biological sample was obtained from a subject that had a Clostridioides difficile infection (CDI) prior to obtaining the sample.
12-22. (canceled)
A method of determining likelihood of Clostridioides difficile infection (CDI) recurrence or prognosing CDI, comprising:
- (a) contacting a substrate to which Clostridioides difficile (C. diff) toxin B (TcdB) is attached with (i) a biological sample and (ii) a labeled antibody that binds to TcdB,
- (b) washing the substrate, and
- (c) detecting a signal from the labeled antibody, wherein a signal intensity that is below a predetermined threshold is indicative of (i) recurrent CDI or a risk thereof, or (ii) a CDI severity or a risk of recurrent CDI, and a signal intensity that is above the predetermined threshold is indicative of lack of CDI severity or a low risk of recurrent CDI;
- wherein the biological sample was obtained from a subject that had or has a Clostridioides difficile infection (CDI).
24-33. (canceled)
A method of treating Clostridioides difficile infection (CDI) in a subject, comprising:
- (a) obtaining a biological sample, wherein the biological sample was obtained from a subject that had a Clostridioides difficile infection (CDI) prior to obtaining the sample,
- (b) contacting a substrate to which TcdB is attached with (i) the biological sample and (ii) a labeled antibody that binds to TcdB,
- (c) washing the substrate,
- (d) detecting a signal from the labeled antibody, wherein the amount of the signal is inversely correlated to CDI severity or likelihood of development of recurrent CDI, and
- (e) treating the subject with a therapeutic for CDI if the amount of the signal is below a predetermined threshold.
36-48. (canceled)
A kit comprising:
- (a) a Clostridioides difficile (C. diff) toxin B (TcdB)-coated substrate;
- and
- (b) a labeled antibody that binds to TcdB;
- or
- a TcdB-coated plate, an enzyme-labeled BB-IgG, and a chemical substrate for the enzyme, wherein the labeled BB-IgG comprises horseradish peroxidase (HRP) conjugated directly or indirectly to BB-IgG.
50-60. (canceled)
Dependencies are inferred from the claim text.