Banerjee D, Michael J, Schmitt B, Salimnia H, Mhaissen N, Goldfarb D M, Lachance P, Faron M L, Aufderheide T, Ledeboer N, Weissfeld A, Selvarangan R
Children's Mercy Hospital, Kansas City, Missouri, USA.
Indiana University School of Medicine, Indianapolis, Indiana, USA.
J Clin Microbiol. 2020 Jun 24;58(7). doi: 10.1128/JCM.01775-19.
Group A streptococcus (GAS) species cause bacterial pharyngitis in both adults and children. Early and accurate diagnosis of GAS is important for appropriate antibiotic therapy to prevent GAS sequalae. The Revogene Strep A molecular assay (Meridian Bioscience Canada Inc, Quebec City, QC, Canada) is an automated real-time PCR assay for GAS detection from throat swab specimens within approximately 70 min. This multicenter prospective study evaluated the performance of the Revogene Strep A molecular assay compared to that of bacterial culture. Dual throat swab specimens in either liquid Amies or Stuart medium were collected from eligible subjects (pediatric population and adults) enrolled across 7 sites (USA and Canada). Revogene Strep A and reference testing was performed within 7 days and 48 h of sample collection, respectively. Of the 604 evaluable specimens, GAS was detected in 154 (25.5%) samples by the reference method and in 175 (29%) samples by the Revogene Strep A assay. Revogene Strep A assay sensitivity and specificity were reported to be 98.1% (95% confidence interval [CI], 94.4 to 99.3) and 94.7% (95% CI, 92.2 to 96.4), respectively. The positive predictive value was 86.3% (95% CI, 80.4 to 90.6), negative predictive value was 99.3% (95% CI, 98.0 to 99.8) with a 1.0% invalid rate. Discrepant analysis with alternative PCR/bidirectional sequencing was performed for 24 false-positive (FP) and 3 false-negative (FN) specimens. Concordant results were reported for 17 (FP only) of 27 discordant specimens. The Revogene Strep A assay had high sensitivity and specificity for GAS detection and provides a faster alternative for GAS diagnosis.
A组链球菌（GAS）可导致成人和儿童患细菌性咽炎。早期准确诊断GAS对于进行适当的抗生素治疗以预防GAS后遗症很重要。Revogene A群链球菌分子检测法（加拿大魁北克市子午线生物科学加拿大公司）是一种自动化实时PCR检测法，可在约70分钟内从咽拭子标本中检测GAS。这项多中心前瞻性研究评估了Revogene A群链球菌分子检测法与细菌培养法相比的性能。从美国和加拿大7个地点招募的符合条件的受试者（儿科人群和成人）中采集置于液体阿氏或 Stuart 培养基中的双份咽拭子标本。Revogene A群链球菌检测和参考检测分别在样本采集后的7天内和48小时内进行。在604份可评估标本中，参考方法在154份（25.5%）样本中检测到GAS，Revogene A群链球菌检测法在175份（29%）样本中检测到GAS。据报告，Revogene A群链球菌检测法的敏感性和特异性分别为98.1%（95%置信区间[CI]，94.4至99.3）和94.7%（95%CI，92.2至96.4）。阳性预测值为86.3%（95%CI，80.4至90.6），阴性预测值为99.3%（95%CI，98.0至99.8），无效率为1.0%。对24份假阳性（FP）和3份假阴性（FN）标本进行了采用替代PCR/双向测序的差异分析。27份不一致标本中有17份（仅FP）报告了一致结果。Revogene A群链球菌检测法对GAS检测具有高敏感性和特异性，并为GAS诊断提供了一种更快的替代方法。
