The performance of the Illumigene group A Streptococcus assay was evaluated by comparing it to culture using 437 consecutive throat swabs. The Illumigene assay was also directly compared to PCR with 161 samples. This Illumigene assay is rapid and easy to perform. The assay also has high sensitivity (100%) compared to culture or PCR and high specificity (99.2%) compared to PCR. A total of 8.8% of the isolates were erythromycin resistant, and 6.9% were clindamycin resistant.
Streptococcus pyogenes (group A streptococcus [GAS]) causes various infections, including acute pharyngitis in children. Rapid and accurate laboratory diagnosis is important for antibiotic therapy that prevents rheumatic fever and probably invasive infections (1). Current standard testing methods include rapid antigen detection, with about 70 to 80% sensitivity, and culture, which takes 24 to 48 h (2). A new molecular method, the Illumigene group A Streptococcus assay, based on loop-mediated isothermal amplification (LAMP) technology for testing GAS, has been developed by Meridian Bioscience and has recently been cleared by the FDA. The target region of the assay is in the GAS pyrogenic exotoxin B (speB) gene (3,4). In this prospective study, the Illumigene group A Streptococcus assay was compared to standard bacterial culture and to PCR targeting the ptsI (phosphotransferase) gene to evaluate its clinical performance.Specimens. Throat swabs routinely submitted for GAS testing by rapid antigen and culture methods were collected from symptomatic children at Ann and Robert H. Lurie Children's Hospital of Chicago. Each specimen was collected with the double-swab system with a liquid Stuart transport medium (Copan Diagnostics, Inc., Murrieta, CA). One swab was used for rapid antigen assay. The second swab was used for culture and the Illumigene group A Streptococcus assay. No patient was enrolled into the study more than once. The study was approved by the Institutional Review Board of Ann and Robert H. Lurie Children's Hospital of Chicago.Illumigene group A Streptococcus assay. One swab was plated onto agar plates for culture and then was used to perform the Illumigene group A Streptococcus assay as described in the manufacturer's product insert. Briefly, the sample in the supplied sample preparation buffer was heated to 95°C for 10 min. Heated samples were transferred to "test" and "control" chambers that contained lyophilized amplification reagents. Both amplification and detection took place on the Illumipro-10 device. The whole process time from preparation to result reading for 1 to 10 specimens was approximately 1 h.Culture and susceptibility. Standard GAS culture was performed with 5% sheep blood agar. GAS identification was based on colony morphology, Gram stain, catalase test, and serogrouping using reagents from PathoDX Strep Grouping distributed by Remel, Lenexa, KS (2). Erythromycin, clindamycin, and levofloxacin susceptibility testing was performed with MICroSTREP Plus panels, and the results were read using the MicroScan Walkaway in...