Patent ID: 9518992
Filing Date: 2016-12-13
CPC Classification: A61K,A61P,C07K,C12Q,G01N

Claim Text:
1. A diagnostic kit for use in diagnosing pre-eclampsia or eclampsia or a propensity to develop pre-eclampsia or eclampsia in a subject, said kit comprising: (a) a first antibody, or antigen-binding fragment thereof, which specifically binds free placental growth factor (PlGF), wherein said first antibody, or antigen-binding fragment thereof, is detectably labeled or coupled to an enzyme; (b) a normal reference sample for PlGF, wherein said normal reference sample for PlGF is a sample containing a level of PlGF found in a pregnant subject not having pre-eclampsia or eclampsia or a propensity to develop pre-eclampsia or eclampsia; a subject not having early-onset pre-eclampsia or eclampsia; or a subject that is not pregnant, wherein the normal reference sample for PlGF comprises purified or recombinant PlGF at a concentration of 400 to 800 pg/ml; (c) a second antibody, or antigen-binding fragment thereof, which binds soluble Flt-1 (sFlt-1), wherein said second antibody or antigen-binding fragment thereof is detectably labeled or coupled to an enzyme; (d) a normal reference sample for sFlt-1, wherein said normal reference for sFlt-1 sample is a sample containing a level of sFlt-1 found in a pregnant subject not having pre-eclampsia or eclampsia or a propensity to develop pre-eclampsia or eclampsia; a subject not having early onset pre-eclampsia or eclampsia; or a subject that is not pregnant, and wherein said normal reference sample comprises purified or recombinant sFlt-1 at a concentration of 0.9-2 ng/ml; and (e) instructions for use of the kit for the diagnosis of pre-eclampsia or eclampsia or the propensity to develop pre-eclampsia or eclampsia in a subject, wherein said instructions comprise a step for comparison between a subject sample and the normal reference sample of (b) and (d), wherein a subject sample with a level of free PlGF that is less than the normal reference sample of step (b) and a level of sFlt-1 that is greater than the normal reference sample of step (d) is diagnostic of pre-eclampsia or eclampsia or the propensity to develop pre-eclampsia or eclampsia.