Kits and methods to distinguish false labor and true labor

Patent metadata

Field	Value
Publication number	US-11204354-B2
Application number	US-201615773980-A
Country	US
Kind code	B2
Filing date	Nov 7, 2016
Priority date	Nov 5, 2015
Publication date	Dec 21, 2021
Grant date	Dec 21, 2021

Abstract

Kits and methods to distinguish between false and true labor are provided. The kits and methods can utilize differences in abundance and/or differences in the rate of change in abundance of B7-H2, SORC2, TF, C1-Esterase Inhibitor, Ran, IMD-H1 and/or PGAM1, as markers of true labor.

First claim

What is claimed is:

1. A kit comprising:
an array that measures tissue factor (TF) in combination with ICOS Ligand (B7-H2), VPS10 Domain Containing Receptor SorCS2 (SORC2), Plasma Protease C1 Inhibitor (C1-Esterase Inhibitor), Ras-related Nuclear protein (Ran), Inosine-5′-monophosphate dehydrogenase (IMDH1), and Phosphoglycerate mutase 1 (PGAM1),
from a sample obtained from a pregnant female.

2. The kit of claim 1 , comprising instructions that direct calculation of a rate of change of abundance in TF, B7-H2, SORC2, and C1-Esterase Inhibitor between two samples obtained from the same pregnant female at two different times (T1 and T2).

3. The kit of claim 2 , wherein the instructions direct calculation of the rate of change of abundance of TF, B7-H2, SORC2, and C1-Esterase Inhibitor with the formula:
(Abundance T2 -Abundance T1 )/(GA T2 -GA T1 ), wherein GA refers to gestational age and can be measured in weeks.

4. The kit of claim 3 wherein:
(a) GA T2 and GA T1 , are between 33 and 40 weeks; and/or
(b) the instructions direct calculation of a true labor score (1) according to the formula:
true labor score(1)=4.4* S (B7H2) −5.9* S (Sorc2) −0.5* S ( TF )−0.03* S (C1-Esterase Inhibitor)+ 1.1,

or
true Labor Score(1)=4.422* S (B7H2) −5.981* S (Sorc2) −0.538* S ( TF )−0.033* S (C1-Esterase Inhibitor) +1.134, wherein S refers to the rate of change of abundance.

5. The kit of claim 4 , wherein in part (b):
a formula result of Score(1)≤−1.14 denotes that the pregnant female is experiencing false labor; and/or
a formula result of Score(1)>0 denotes that the pregnant female is in true labor.

6. The kit of claim 2 wherein:
the instructions direct that the sample be obtained when the pregnant female is experiencing symptoms associated with false labor and true labor, which symptoms are optionally contractions; and/or
the samples are plasma or serum samples; and/or
the array comprises one or more well(s) coated with:
anti-TF antibodies; and/or
anti-B7-H2 antibodies; and/or
anti-SORC2 antibodies; and/or
anti-C1-Esterase Inhibitor antibodies.

7. The kit of claim 1 comprising instructions that direct calculation of changes in abundance (CA) of TF, Ran, IMDH1, and PGAM1 as compared to a reference level calculated from samples derived from a reference population, at a time when members of said reference population were not in true labor.

8. The kit of claim 7 comprising instructions that direct calculation of a true labor score (2), wherein CA TF , CA Ran , CA IMDH1 , and CA PGAM1 are used in a Linear Discriminant Analysis Model.

9. The kit of claim 8 comprising instructions that direct analysis of true labor score (2);
wherein true labor score (2) comprises two threshold values, X and Y,
wherein a true labor score (2)≤X denotes that the pregnant female is in false labor, and
wherein a true labor score (2)>Y denotes that the pregnant female is in true labor.

10. The kit of claim 6 , wherein:
the array comprises one or more well(s) coated with
anti-TF antibodies; and/or
anti-Ran antibodies; and/or
anti-IMDH1 antibodies; and/or
anti-PGAM1 antibodies.

Assignees

• Univ Wayne State
• Us Health

Inventors

• Tarca Adi L
• Chaemsaithong Piya
• Chaiworapongsa Tinnakorn
• Hassan Sonia S
• Romero Roberto

Classifications

• G01N33/543

  with an insoluble carrier for immobilising immunochemicals · CPC title

• C12Y101/01205

  IMP dehydrogenase (1.1.1.205) · CPC title

• C12Y504/02

  Phosphotransferases (phosphomutases) (5.4.2) · CPC title

• G16B5/20

  Probabilistic models · CPC title

• G01N33/689 Primary

  related to pregnancy or the gonads · CPC title