Screening Pregnant Women for Bacterial Vaginosis Using a Point-of-Care Test: A Prospective Validation Study
Philipp Foessleitner, Herbert Kiss, Julia Deinsberger, Julia Ott, Lorenz Zierhut, Klára Rosta, Veronica Falcone, Alex Farr
Abstract
Bacterial vaginosis in early pregnancy is associated with an increased risk of preterm birth. The introduction of a simple screen-and-treat program into antenatal care was shown to significantly reduce the rate of preterm birth. The gold standard for diagnosing bacterial vaginosis is Gram staining, which is, however, time-consuming and requires laboratory facilities. The objective of this prospective study was to validate a point-of-care sialidase activity detection test (OSOM® BVBLUE® Test) for asymptomatic pregnant women and evaluate its accuracy as a screening tool. We enrolled 200 pregnant participants, 100 with Gram staining-confirmed bacterial vaginosis and 100 healthy controls. Compared to Gram staining, the point-of-care test showed a sensitivity of 81%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 98.1%. In conclusion, we found that the OSOM® BVBLUE® Test was an accurate method for diagnosing bacterial vaginosis in asymptomatic pregnant women. This point-of-care test can therefore be considered a reliable and easy-to-use screening tool for bacterial vaginosis during pregnancy.