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US 12,607,639 B2Granted
Diagnostic blood test for sarcoidosis
OwnerDavid R. Mollerinventor
Life of this patent
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Abstract
Sarcoidosis is a multisystem disease characterized by granulomatous inflammation in affected organs. The present invention discloses kits and a system for a blood test using mycobacterial catalase-peroxidase that has a high positive predictive value for confirming a diagnosis of sarcoidosis.
Claims18
A method for detecting an individual who has sarcoidosis or whose blood indicates the presence of sarcoidosis, the method comprising the steps of:
- a. creating a background test material comprising immune cells from a first aliquot of whole blood;
- b. creating a microbial catalase-peroxidase protein stimulated test material by contacting immune cells from a second aliquot of whole blood with a first composition comprising an antigenic fragment of a microbial catalase-peroxidase protein;
- c. creating a purified protein derivative (PPD)-stimulated test material by contacting immune cells from a third aliquot of whole blood with a second composition comprising PPD, where the PPD is of a mycobacterial species;
- d. incubating the test materials;
- e. determining concentrations of interferon-gamma (INFγ) released from each of the test materials;
- and
- f. evaluating the concentrations of INFγ, defining a positive result if the concentration of INFγ in the microbial catalase-peroxidase protein-stimulated material minus the concentration of INFγ in the background test material is greater than a first threshold level, and the concentration of INFγ in the microbial catalase-peroxidase protein-stimulated test material minus the concentration of INFγ in the PPD-stimulated test material is greater than a second threshold level,
- wherein the concentration of the microbial catalase-peroxidase protein is ≥0.1 mcg/ml and the concentration of PPD is ≥0.1 mcg/ml, and
- wherein the antigenic fragment of the microbial catalase-peroxidase protein comprises:
- (i) amino acids 321-335 of SEQ ID NO:
- 2, amino acids 328-340 of SEQ ID NO:
- 2,
- (ii) SEQ ID NO:
- 3,
- (iii) SEQ ID NO:
- 4,
- (iv) SEQ ID NO:
- 5,
- (v) SEQ ID NO:
- 6,
- (vi) SEQ ID NO:
- 7,
- (vii) SEQ ID NO:
- 8, or
- (viii) a combination thereof.
22 more elements
Dependencies are inferred from the claim text.