Screening Pregnant Women for Bacterial Vaginosis Using a Point-of-Care Test: A Prospective Validation Study

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.