Methods for predicting time-to-delivery in pregnant women
AssigneeN-Dia, Inc.
InventorsAnthony Ausiello, Ruben Salinas, Michael Thompson, Daniel J. Mackey, Kaitlyn Nardozzi, Michael Friedman
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Abstract
The present disclosure relates to methods for predicting time-to-delivery in pregnant women. The methods include predicting that a pregnant woman will deliver within a predetermined time frame if PAMG-1 is determined to be present at a level above a predetermined detection threshold in a vaginal fluid sample obtained from the pregnant woman. Also provided are methods for determining a patient's risk of preterm labor and/or spontaneous rupture of the chorioamniotic membrane.
Claims45
A method of predicting time to delivery (TTD), the method comprising:
- (a) contacting a vaginal fluid sample obtained from a pregnant woman with at least two PAMG-1-specific monoclonal antibodies, wherein at least one of the antibodies binds to PAMG-1 when present in the sample to form a PAMG-1/monoclonal antibody complex;
- (b) detecting the presence of the PAMG-1/monoclonal antibody complex in the sample only when the concentration of PAMG-1 in the sample exceeds a predefined detection threshold;
- and
- (c) predicting that the pregnant woman will deliver within a predetermined time frame if PAMG-1 is detected;
- or predicting that the pregnant woman will not deliver within the predetermined time frame if PAMG-1 is not detected.
A method for determining the risk of preterm delivery, the method comprising:
- (a) contacting a vaginal fluid sample obtained from a pregnant woman with at least two PAMG-1-specific monoclonal antibodies, wherein at least one of the antibodies binds to PAMG-1 when present in the sample to form a PAMG-1/monoclonal antibody complex;
- (b) detecting the presence of the PAMG-1/monoclonal antibody complex in the sample only when the concentration of PAMG-1 in the sample exceeds a predefined detection threshold;
- and
- (c) predicting that the pregnant woman is at risk of preterm delivery if PAMG-1 is detected;
- or predicting that the pregnant woman is not at risk of preterm delivery if PAMG-1 is not detected.
A method for determining a pregnant woman's risk of spontaneous rupture of the chorioamniotic membranes, the method comprising:
- (a) contacting a vaginal fluid sample obtained from a pregnant woman with at least two PAMG-1-specific monoclonal antibodies, wherein at least one of the antibodies binds to PAMG-1 when present in the sample to form a PAMG-1/monoclonal antibody complex;
- (b) detecting the presence of the PAMG-1/monoclonal antibody complex in the sample only when the concentration of PAMG-1 in the sample exceeds a predefined detection threshold;
- and
- (c) determining that the pregnant woman is at risk of spontaneous rupture of the chorioamniotic membranes if PAMG-1 is detected;
- or determining that the pregnant woman is not at risk of spontaneous rupture of the chorioamniotic membranes if PAMG-1 is not detected.
A kit comprising:
- (a) a device for detecting the presence of PAMG-1 in a vaginal fluid sample when present at a level above a predetermined threshold;
- and a vaginal swab.
Dependencies are inferred from the claim text.