Methods of use for an immunoassay detecting fragment Ba
View Patent ↗Methods, compositions and kits for detecting the complement Factor B cleavage product Ba in a biological sample are described. These methods, compositions and kits are useful in convenient, reliable and early diagnosis of or ruling out pre-eclampsia in a pregnant human subject.
1. A method for ruling out pre-eclampsia in a pregnant human subject, comprising:
obtaining, at a time period between 10 and 19 weeks of pregnancy, a sample of a body fluid from the subject;
contacting the sample with a highly-specific antibody to a neo-epitope on fragment Ba (residues 26-259 of human complement Factor B, herein identified as SEQ ID NO: 1), which antibody does not substaintially recognize Factor B or Bb;
assessing whether the antibody detects the presence of Ba in the sample; and
identifying as “ruled-out” those pregnant human subjects for which no Ba is detected.
2. The method of claim 1 , wherein a risk factor of developing pre-eclampsia at a later point in pregnancy or after parturition is assigned.
3. The method of claim 1 , wherein the body fluid is urine.
4. The method of claim 1 , wherein the body fluid is blood.
5. The method of claim 1 , wherein the body fluid is plasma.
6. The method of claim 1 , wherein the body fluid is serum.
7. A kit for use in the method of claim 1 , comprising:
a first antibody highly-specific for binding a neo-epitope on Ba but does not substantially recognize Factor B or Bb; and
a detection agent.
8. The kit of claim 7 , further comprising a second antibody specific for the first antibody.