A New Real-Time PCR Test (Flora Select™) and Nugent Score for the Diagnosis of Bacterial Vaginosis During Pregnancy.

This prospective cohort study aimed to evaluate the performance of Flora select™ (FS), a newly developed real-time PCR test, for the assessment of the vaginal microbiome during early pregnancy. Five hundred and fifty-six pregnant women underwent examinations of FS, Nugent score-a Gram-staining scoring system for the diagnosis of bacterial vaginosis (BV)-and conventional bacterial culture between 8 weeks and 12 gestational weeks. Nugent scores of 0-3, 4-6, and ≥7 were found in 469 (84.2%), 41 (7.4%), and 47 (8.5%) of the women, respectively. Relative dominance rates of species of high (≥80% medium (50%≤, <80%), and low (0.1≤, <50%), and no detection (<0.1%) were 63.0%, 8.8%, 17.1%, and 11.2%, respectively. , , , , , and species were detected in 23.9%, 17.6%, 17.1%, 7.0%, 23.0%, and 4.9% of the women, respectively. species were detected in all women with Nugent scores ≥7 and were detected in 40.4% of them. BV-associated bacterial species were also detected in 70.7% of women with Nugent scores of 4-6. , , , , , and species were highly prevalent in women with Nugent scores ≥4 or species <50%. FS detected , , and species more effectively than conventional bacterial culture. FS could determine relative dominance rates of species in the vaginal microbiome, and simultaneously detect four kinds of BV-associated bacteria, and species. Therefore, FS may be clinically useful for the screening of the vaginal microbiome during pregnancy to prevent preterm birth and for the assessment of the vaginal microbiome after BV treatments.