Green M, Dashefsky B, Wald E R, Laifer S, Harger J, Guthrie R
University of Pittsburgh School of Medicine, Department of Pediatrics, Pennsylvania.
J Clin Microbiol. 1993 Jan;31(1):78-82. doi: 10.1128/jcm.31.1.78-82.1993.
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.
作为一项评估产时抗原检测用于筛查B族链球菌（GBS）重度阴道定植疗效的临床研究的一部分，我们比较了改良Bactigen和Directigen GBS乳胶颗粒凝集（LPA）试剂盒的性能。从分娩期妇女获取的配对阴道拭子被迅速送往实验室，用于培养（两个拭子）和LPA检测（每种方法各用一个拭子）。GBS生长情况进行半定量评估，并进一步分为轻度或重度生长。通过比较同一拭子的LPA和培养结果来确定每种方法的性能指标。在研究期间共评估了4251对拭子。Bactigen和Directigen检测任何程度GBS生长的性能指标分别如下：灵敏度，20%和24%；特异性，99%和99%。Bactigen和Directigen检测重度定植的性能指标分别如下：灵敏度，57%和62%；特异性，99%和99%。两种LPA试剂盒均不是GBS阴道定植或新生儿感染的敏感指标。
