Follistatin-like protein-1 as a biomarker for sepsis
View Patent ↗The present invention relates to methods and kits for diagnosing systemic inflammatory response syndrome or sepsis using levels of FSTL-1.
1. A method of diagnosing sepsis in a subject, comprising (i) determining the level of follistatin-like protein-1 in a serum sample from a subject manifesting one or more of: an identified locus of infection, fever or a body temperature lower than normal; tachycardia; tachypnea; an elevated white blood cell count or neutropenia and/or greater than 10% immature band forms; (ii) comparing the level of follistatin-like protein-1 in the serum sample to a control level of follistatin-like protein-1 as determined by measuring the follistatin-like protein-1 level in serum from one or more healthy subjects, and (iii) diagnosing sepsis where a serum level of follistatin-like protein-1 in the sample of the subject is at least 50% higher than the control level of follistatin-like protein-1 indicates that the subject has sepsis.
2. A method of diagnosing sepsis in a human subject, comprising (i) determining the level of follistatin-like protein-1 in a serum sample from a human subject manifesting one or more of: an identified locus of infection, a body temperature greater than 38.3° C. or less than 36° C.; a heart rate greater than 90 beats/min; a respiratory rate greater than 20 breaths per minute and/or PaCO 2 less than 32 mm Hg; a white blood cell count greater than 12×10 9 per liter or less than 4×10 9 per liter, and/or greater than 10% immature band forms; (ii) comparing the level of follistatin-like protein-1 in the serum sample to a control level of follistatin-like protein-1 as determined by measuring the follistatin-like protein-1 level in serum from one or more healthy human subjects, and (iii) diagnosing sepsis where a serum level of follistatin-like protein-1 in the sample of the subject is at least 50% higher than the control level of follistatin-like protein-1 indicates that the subject has sepsis.
3. The method of claim 1 or 2 , where the level of follistatin-like protein-1 is determined by enzyme linked immunosorbent assay.
4. The method of claim 1 , 2 or 3 , where the human subject has been determined to not suffer from an autoimmune disease.
5. The method of claim 2 , 3 or 4 , where the human subject has not previously been diagnosed with autoimmune arthritis.
6. A method of diagnosing sepsis in a human subject, comprising (i) determining the level of follistatin-like protein-1 in a serum sample from a human subject manifesting one or more of: an identified locus of infection, a body temperature greater than 38.3° C. or less than 36° C.; a heart rate greater than 90 beats/min; a respiratory rate greater than 20 breaths per minute and/or PaCO 2 less than 32 mm Hg; a white blood cell count greater than 12×10 9 per liter or less than 4×10 9 per liter, and/or greater than 10% immature band forms; and (ii) diagnosing sepsis where the serum level of the subject is above 120 ng/ml.
7. The method of claim 6 , where the level of follistatin-like protein-1 is determined by enzyme linked immunosorbent assay.
8. The method of claim 6 or 7 , where the human subject has been determined to not suffer from an autoimmune disease.
9. The method of claim 6 , 7 or 8 , where the human subject has not previously been diagnosed with autoimmune arthritis.
10. The method of claim 6 , 7 , 8 or 9 where the level of follistatin-like protein-1 in the serum sample is greater than 150 ng/ml.
11. The method of claim 6 , 7 , 8 or 9 where the level of follistatin-like protein-1 in the serum sample is greater than or equal to 200 ng/ml.