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

Abstract

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.