Clinical Innovations ROM Plus
Clinical Innovations, is the largest medical device company exclusively focused on labor and delivery, including the ROM Plus®, a rupture of membranes (ROM) diagnostic test, which provides immediate results to help minimize potential risks to expectant mothers and their babies. The device’s accuracy and ease of use provides a less invasive and more efficient alternative to traditional ROM detection methods
Clinical innovations wanted to develop and produce a self-contained test kit that provides qualitative results for rupture of fetal membranes and can be performed at point-of-care sites or in a lab
Spontaneous rupture of membranes can occur at any gestational age and presents a particularly serious clinical problem if it occurs prior to 37 weeks gestation where it is responsible for 20%–40% of preterm births. Thus, accurate and timely diagnosis of membrane rupture is imperative to inform and guide gestational age-specific interventions to optimize perinatal outcomes and reduce the risk of serious complications, including preterm delivery and infections such as chorioamnionitis and neonatal sepsis. An incorrect diagnosis of membrane rupture (i.e. false positive test) can also have serious clinical ramifications, such as the initiation of unnecessary obstetrical interventions that may include hospitalization, administration of medications, and even iatrogenic premature delivery. They approached Timestrip for Time indicators which would be required for these test devices.
The ROM test cassette/kit has a built-in twenty minute time monitoring Timestrip indicator and lateral flow test strip as well as a patient ID field. The results manifest within 5-20 minutes. 5,10 and 20 minutes are clearly marked on the Timestrip, allowing for clinicians to have a clear visual indication of when results are ready. With an accurate diagnosis of PROM (premature rupture of membranes), patients can receive interventions to minimize the risk of complications.