Multicenter Performance Evaluation of the Revogene® GBS DS Real-Time PCR Assay for Group B Streptococcus Detection During Labor.

Purpose: This study aimed to evaluate the performance and ease of use of the Revogene® GBS DS PCR assay for the intrapartum detection of Group B Streptococcus (GBS) colonization, as compared with intrapartum culture and antenatal culture-based screening. Methods: Between April and August 2019, 398 women who gave birth in one of the three maternities participating in this study agreed to the collection of a vaginal swab when they arrived in the labor ward. The samples were immediately sent to the adjacent laboratory where they were discharged into the buffer provided with the Revogene® GBS DS assay. Part of the buffer was used to perform the Revogene® GBS DS test, and part of the same buffer was used for GBS culture. Results: The Revogene® GBS DS assay provided a valid result in less than 70 min for 356 (89%) women. The sensitivity of the test was 85.7% (66.4–95.3%). The specificity of the test was 99.1% (97.3–99.8%). The positive predictive value was 88.9% (69.7–97.1%). The negative predictive value was 98.9% (96.9–99.6%). Conclusion: The easy-to-use Revogene® GBS DS assay provides a valuable tool for the detection of GBS colonization at the beginning of labor. The sensitivity and turn-around time are adequate. The high number of invalid results needs to be addressed before the Revogene® GBS DS test can be expected to replace the current screening-based approach. [ABSTRACT FROM AUTHOR]