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.