US 12,436,155 B2
Preeclampsia screening device and methods measuring activin and/or inhibin A
Denali K. Dahl, Chapel Hill, NC (US); Brian Matovu, Kampala (UG); and Zoe Sekyonda, Cleveland, OH (US)
Assigned to KALIA HEALTH, INC., Chapel Hill, NC (US)
Filed by Kalia Health, Inc., Chapel Hill, NC (US)
Filed on Apr. 16, 2021, as Appl. No. 17/232,513.
Claims priority of provisional application 63/011,167, filed on Apr. 16, 2020.
Prior Publication US 2021/0325400 A1, Oct. 21, 2021
Int. Cl. G01N 33/68 (2006.01); G01N 33/543 (2006.01)
CPC G01N 33/689 (2013.01) [G01N 33/54388 (2021.08); G01N 2800/368 (2013.01)] 14 Claims
 
1. A diagnostic and/or screening test for preeclampsia (PE), the diagnostic and/or screening test comprising:
a test antibody with an affinity to activin A and inhibin A;
a control antibody; and
a detectable moiety configured to be detectable when activin A and inhibin A is present at a threshold concentration in a sample,
wherein the threshold concentration of activin A is greater than about 0.064-0.435 ng/ml and the threshold concentration of inhibin A is greater than about 0.064-0.417 ng/ml,
wherein the diagnostic and/or screening test is configured in a lateral-flow immunoassay format, and
wherein the diagnostic and/or screening test detects the threshold concentration of activin A and the threshold concentration of inhibin A simultaneously in a sample, with a specificity of about 80% to about 95% and a sensitivity of about 50% to about 60% for activin A, and a specificity of about 70% to about 89% and a sensitivity of about 60% to about 70% for inhibin A.