Oova: A two-in-one at-home test for measuring luteinizing hormone and progesterone

Divaraniya, A. PhD.

Abstract:

Several studies were conducted to assess the performance of the Oova urine device for the quantitative measurement of Luteinizing Hormone (LH) and Pregnanediol-3 (PdG) in urine. Urine is collected in both midstream and dip test formats, and results are conveyed via lateral flow immunoassay, like a pregnancy test. The results are subsequently interpreted in real-time using a machine learning-empowered smartphone application. The disposable tests do not require special storage and are tested in layperson use.

Our research found that urine collected and tested using the Oova device provides accurate LH and PdG results when compared with commercial lab analysis. Device precision studies showed that Oova performs consistently when used by multiple professionals and using multiple manufacturing lots of devices. Study technicians found that Oova was easy to use and interpret. Practitioners strongly
preferred the Oova device over other hormone-measuring products, including over-the-counter (OTC) tests, and in some instances, it was clear that Oova had the potential to replace conventional lab work for hormone trend monitoring.

Oova is registered with the FDA. Future studies will assess the performance of testing other analytes.