Detecting complement activation

Abstract

Methods of detecting complement activation including steps of detecting in a sample from a subject a level of iC3b wherein the detecting involves specific interaction between the iC3b and a non-cross-reactive antibody thereto, comparing the detected level with a reference level, which reference level is within a range of about 10 ng/ml to about 5,000 ng/ml, wherein determination that the detected level is above the reference level indicates that the subject is suffering from or susceptible to undesirable and/or pathologic complement activation, and administering treatment to treat undesired complement activation if the detected level is above the reference level. Other methods of detecting complement activation with or without measuring iC3b are also provided.

1 . A method comprising steps of
 detecting in a sample from a subject a level of intact C3, wherein the detecting involves specific interaction between the intact C3 and a non-cross-reactive antibody thereto;   comparing the detected level with a reference level, which reference level is within a range of about 350 ug/ml to about 1,700 ug/ml; wherein determination that the detected level is below the reference level indicates that the subject is suffering from or susceptible to undesirable and or/pathologic complement activation; and   administering treatment to treat undesired complement activation if the detected level is below the reference level.   
     
     
         2 . The method  claim 1 , wherein the non-cross-reactive antibody is characterized in that a 1 ug/ul solution of ic3B produces a signal equivalent to less than about 1 ng/ml of C3. 
     
     
         3 . The method of  claim 2 , wherein the non-cross-reactive antibody is or comprises HM2075. 
     
     
         4 . The method of  claim 1 , wherein the detecting and comparing steps may be carried out in about 30 minutes or less. 
     
     
         5 . The method of  claim 1 , wherein the undesirable and/pathologic complement activation is caused by a disorder selected from the group consisting of systemic lupus erythematosus, trauma, inflammatory stress, autoimmune disorders, intracranial hemorrhage, infection, transplant rejection, ocular disease, heart disease, ischemia/reperfusion injury, age-related macular degeneration, paroxysmal nocturnal hemoglobinuria, hereditary aniodema, renal disease, pregnancy-associated disorders, and neurological disorders. 
     
     
         6 . The method of  claim 1 , wherein the sample is selected from the group consisting of whole blood, serum, plasma, urine, tears, saliva, wound exudate, bronchoalveolar lavage fluid, and cerebrospinal fluid. 
     
     
         7 . The method of  claim 1 , wherein the step of detecting is performed under controlled conditions such that performance of the step does not substantially activate complement within the sample. 
     
     
         8 . The method of  claim 1 , wherein the detecting and comparing steps are not carried out using an ELISA assay. 
     
     
         9 . The method of  claim 1 , wherein the detecting and comparing steps are carried out using a lateral flow assay. 
     
     
         10 .- 27 . (canceled)