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US 9,518,992 B2Granted
Kits for the diagnosis of pre-eclampsia or eclampsia
AssigneeBeth Israel Deaconess Medical Center, Inc.
InventorsS. Ananth Karumanchi, Vikas P. Sukhatme
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Abstract
Disclosed herein are kits for diagnosing pre-eclampsia and eclampsia or a propensity to develop pre-eclampsia or eclampsia that include agents for the detection of levels of free placental growth factor in a subject.
Claims20
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.
7 more elements
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 positive reference sample for PlGF, wherein said positive reference sample for PlGF is a sample containing a level of PlGF found in a pregnant subject having pre-eclampsia, eclampsia, or early-onset pre-eclampsia or a propensity to develop pre-eclampsia, eclampsia, or early-onset pre-eclampsia, wherein the positive reference sample for PlGF comprises purified or recombinant PlGF at a concentration of less than 400 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 positive reference sample for sFlt-1, wherein said positive reference sample for sFlt-1 is a sample containing a level of sFlt-1 found in a pregnant subject having pre-eclampsia, eclampsia, or early-onset pre-eclampsia or a propensity to develop pre-eclampsia, eclampsia, or early-onset pre-eclampsia, and wherein said positive reference sample of comprises purified or recombinant sFlt-1 at a concentration of greater than 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 the subject sample and positive reference sample of (b) and (d), wherein a subject sample with a level of free PlGF that is less than or equal to the positive reference sample of step (b) and a level of sFlt-1 that is greater than or equal to the positive reference sample of step (d) is diagnostic of pre-eclampsia or eclampsia or the propensity to develop pre-eclampsia or eclampsia.
3 more elements
Dependencies are inferred from the claim text.