title: Comparison of two antigen assays for rapid intrapartum detection of vaginal group B streptococcal colonization.
abstract: As part of a clinical investigation evaluating the efficacy of intrapartum antigen detection for screening for heavy vaginal colonization with group B streptococci (GBS), we compared the performance of modified Bactigen and Directigen GBS latex particle agglutination (LPA) kits. Paired vaginal swabs obtained from women in labor were rapidly transported to the laboratory and used for culturing (both swabs) and LPA testing (one swab by each method). GBS growth was estimated semiquantitatively and further designated as light or heavy growth. Performance specifications for each method were determined by comparing LPA and culture results from the same swab. A total of 4,251 paired swabs were evaluated during the study period. The performance specifications for detecting GBS growth of any degree for Bactigen and Directigen, respectively, were as follows: sensitivity, 20 and 24%; specificity, 99 and 99%. The performance specifications for heavy colonization for Bactigen and Directigen, respectively, were as follows: sensitivity, 57 and 62%; specificity, 99 and 99%. Neither LPA kit was a sensitive indicator of vaginal colonization with GBS or neonatal infection.
authors.affiliation: University of Pittsburgh School of Medicine, Department of Pediatrics, Pennsylvania.
authors.forename: M
authors.initials: M
authors.lastname: Green
authors.forename: B
authors.initials: B
authors.lastname: Dashefsky
authors.forename: E R
authors.initials: ER
authors.lastname: Wald
authors.forename: S
authors.initials: S
authors.lastname: Laifer
authors.forename: J
authors.initials: J
authors.lastname: Harger
authors.forename: R
authors.initials: R
authors.lastname: Guthrie
mesh_terms: D000942:Antigens, Bacterial / Q000302:isolation & purification; D016470:Bacteremia / Q000517:prevention & control; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D007232:Infant, Newborn, Diseases / Q000382:microbiology / Q000517:prevention & control; D007841:Latex Fixation Tests; D011247:Pregnancy; D011251:Pregnancy Complications, Infectious / Q000175:diagnosis* / Q000276:immunology; D011933:Reagent Kits, Diagnostic; D012680:Sensitivity and Specificity; D013290:Streptococcal Infections / Q000175:diagnosis* / Q000276:immunology / Q000517:prevention & control; D013292:Streptococcus agalactiae / Q000276:immunology*; D014621:Vagina / Q000382:microbiology; D016585:Vaginosis, Bacterial / Q000175:diagnosis* / Q000382:microbiology
chemical_list: D000942:Antigens, Bacterial; D011933:Reagent Kits, Diagnostic