Objective: To determine the validity of a novel Group B Streptococcus (GBS) diagnostic assay for the detection of GBS in antepartum patients.
Study design: Women were screened for GBS colonization at 35 to 37 weeks of gestation. Three vaginal-rectal swabs were collected per patient; two were processed by traditional culture (commercial laboratory versus in-house culture), and the third was processed by an immunoblot-based test, in which a sample is placed over an antibody-coated nitrocellulose membrane, and after a six-hour culture, bound GBS is detected with a secondary antibody.
Results: 356 patients were evaluated. Commercial processing revealed a GBS prevalence rate of 85/356 (23.6%). In-house culture provided a prevalence rate of 105/356 (29.5%). When the accelerated GBS test result was compared to the in-house GBS culture, it demonstrated a sensitivity of 97.1% and a specificity of 88.4%. Interobserver reliability for the novel GBS test was 88.2%.
Conclusions: The accelerated GBS test provides a high level of validity for the detection of GBS colonization in antepartum patients within 6.5 hours and demonstrates a substantial agreement between observers.