Screening tools available include cervical length measurement and fetal fibronectin but are only recommended for high risk of PTB pregnancies defined as either those with a previous PTB, mid-trimester loss, or cervical trauma and are not suitable for population-wide risk stratification. Out of the surviving infants, those born before 28 weeks of gestation are especially at increased risk of neurodevelopmental disorders and chronic health conditions. Recent advancements in medicine and biotechnology have improved infant survival rates substantially however, about 1 in 10 babies are born preterm, resulting in 1 million deaths per year. Preterm birth (PTB) is the birth before the 37th week of pregnancy and is currently the leading cause of death in children under 5. More generally, the universal and versatile nature of this novel sample preprocessing platform can further improve the robustness of existing NALFTs and facilitate their application at the POC. Herein, a key step is represented toward a first bedside test for risk-stratification during pregnancy by predicting true outcome at a very early stage. This next-generation LFT is sensitive enough to detect endogenous concentrations of miR-150-5p, a predictive biomarker for preterm birth (PTB) found deregulated in maternal blood from as early as 12th week of pregnancy. This is achieved through integration of a denaturing hydrogel composite material onto the LFT, allowing for near-instantaneous on-chip release of miRs from their carriers (extracellular vesicles or transport proteins) prior to detection. Herein, a nucleic acid lateral flow test (NALFT) is reported on that enables the direct detection of endogenous miRs from as little as 3 μL of plasma without the requirement for any enzyme-catalyzed target amplification or complex miR extraction steps. Despite extensive research toward the development of point-of-care nucleic acid tests (POC NATs) for the detection of microRNAs (miRs) from liquid biopsies, major hurdles remain including the strict requirement for extensive off-chip sample preprocessing.

Jstock indicator scanner