Kits and methods to distinguish false labor and true labor

Patent metadata

Field	Value
Publication number	US-12287340-B2
Application number	US-202418414339-A
Country	US
Kind code	B2
Filing date	Jan 16, 2024
Priority date	Nov 5, 2015
Publication date	Apr 29, 2025
Grant date	Apr 29, 2025

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, IMDH1 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 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 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.

3. The kit of claim 2 comprising instructions that direct calculation of a true labor score using change of abundance of true labor markers, wherein CA TF , CA Ran , CA IMDH1 , and CA PGAM1 are used in a Linear Discriminant Analysis Model.

4. The kit of claim 3 comprising instructions that direct analysis of the true labor score;
wherein the true labor score comprises two threshold values, X and Y,
wherein a true labor score≤X denotes that the pregnant female is in false labor, and
wherein a true labor score>Y denotes that the pregnant female is in true labor.

5. The kit of claim 1 , comprising instructions that direct sample collection be obtained from a pregnant female between 33 and 40 weeks of the female's pregnancy.

6. The kit of claim 1 , comprising instructions to collect a plasma or serum sample.

7. The kit of claim 1 , comprising instructions to collect the sample when the pregnant female is experiencing symptoms associated with false labor and true labor, wherein the symptoms optionally are contractions.

8. The kit of claim 1 , 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
• The Us Secretary Department Of Health & Human Services

Inventors

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

Classifications

• G06F17/18

  for evaluating statistical data {, e.g. average values, frequency distributions, probability functions, regression analysis (forecasting specially adapted for a specific administrative, business or logistic context G06Q10/04)} · CPC title

• G01N2800/368

  Pregnancy complicated by disease or abnormalities of pregnancy, e.g. preeclampsia, preterm labour · CPC title

• G01N2333/4727

  Calcium binding proteins, e.g. calmodulin · CPC title

• G01N33/543

  with an insoluble carrier for immobilising immunochemicals · CPC title

• C12Y504/02

  Phosphotransferases (phosphomutases) (5.4.2) · CPC title