Fox James W, Cohen Daniel M, Marcon Mario J, Cotton William H, Bonsu Bema K
Department of Pediatrics, Division of Emergency Medicine, Children's Hospital of Akron, Akron, Ohio 44308, USA.
J Clin Microbiol. 2006 Nov;44(11):3918-22. doi: 10.1128/JCM.01399-06. Epub 2006 Sep 13.
Rapid carbohydrate antigen tests are frequently used to diagnose group A streptococcal (GAS) pharyngitis. Despite evidence of modest sensitivity in medical settings, rapid antigen tests are available to the public for self-testing. We sought to determine if the personnel performing a rapid streptococcal antigen test influence the test's performance characteristics. Throat swabs of pediatric patients performed for GAS pharyngitis in a tertiary-care children's hospital network were included during two study periods in 2004 and 2005. The performance characteristics of a rapid carbohydrate antigen test were evaluated in three clinical settings against a nucleic acid probe test method according to the personnel performing the test (laboratory technologist versus nonlaboratory personnel). Between the study periods, nonlaboratory personnel from one site underwent retraining. Subsequently, the performance characteristics of the rapid antigen test were reassessed. The sensitivity of the rapid antigen test varied widely among the different testing sites (56 to 90%). Notably, test sensitivity was consistently greater when the test was performed by laboratory technologists than when it was performed by nonlaboratory personnel (P < 0.0001). Although the rapid antigen test sensitivity significantly improved after nonlaboratory personnel at one testing site were retrained (sensitivity before versus after retraining; P < 0.0001), the sensitivity remained greater in the laboratory technologist cohort (P < 0.0001). These data confirm the important relationship of the operator performing a rapid streptococcal antigen test with the test's accuracy, even in a clinical setting, where operator training is mandated. Therefore, its use outside the medical setting by lay persons cannot be recommended without culture backup.
快速碳水化合物抗原检测常用于诊断A组链球菌(GAS)咽炎。尽管在医疗机构中该检测的敏感性一般,但快速抗原检测仍可供公众自行检测。我们试图确定进行快速链球菌抗原检测的人员是否会影响检测的性能特征。在2004年和2005年的两个研究期间,纳入了一家三级儿童专科医院网络中因GAS咽炎接受检测的儿科患者的咽拭子样本。根据进行检测的人员(实验室技术人员与非实验室人员),在三种临床环境中,将快速碳水化合物抗原检测的性能特征与核酸探针检测方法进行了比较。在研究期间,来自一个地点的非实验室人员接受了再培训。随后,对快速抗原检测的性能特征进行了重新评估。快速抗原检测的敏感性在不同检测地点差异很大(56%至90%)。值得注意的是,由实验室技术人员进行检测时,检测敏感性始终高于非实验室人员进行检测时(P<0.0001)。尽管一个检测地点的非实验室人员接受再培训后,快速抗原检测的敏感性显著提高(再培训前后的敏感性;P<0.0001),但在实验室技术人员组中敏感性仍然更高(P<0.0001)。这些数据证实了进行快速链球菌抗原检测的操作人员与检测准确性之间的重要关系,即使在要求操作人员接受培训的临床环境中也是如此。因此,在没有培养备份的情况下,不建议非专业人员在医疗环境之外使用该检测。