Zhang Ruiqing, Qi Shunxiang, Li Jiandong, Liu Shiyou, Han Guangyue, Shen Xinxin, Li Qi, Xu Wenbo, Ma Xuejun
National Institute for Viral Disease Control and Prevention, China CDC, Beijing, China.
Hebei Center for Disease Control and Prevention, Shijiazhuang City, Hebei Province, China.
China CDC Wkly. 2022 Jun 10;4(23):504-508. doi: 10.46234/ccdcw2022.111.
Recently, a local cluster epidemic has occurred in Shijiazhuang City, Hebei Province. Failure to promptly identify patients with fever in rural areas was the major reason for this epidemic.
We presented the field evaluation of a new real-time reverse transcription recombinase-aided amplification (RT-RAA) kit incorporating an endogenous internal control in a single-tube format, completed at the Hebei CDC from January 17, 2021 to January 27, 2021.
We evaluated the diagnostic performance of RT-RAA assay using automatic extracted RNA of 808 clinical samples. Compared with reverse transcriptase real-time quantitative PCR (qRT-PCR), RT-RAA kit achieved 92.41% sensitivity, 98.78% specificity and a 96.29% coincidence rate, demonstrating an excellent agreement between the RT-RAA assay and qRT-PCR assay. Furthermore, 58 samples were extracted using a manual extraction method within 5 minutes, but only samples with high nucleic acid concentration (cycle threshold value not higher than 32) could be stably detected.
The RT-RAA is more suitable to meet the needs of rapid, sensitive, and accurate detection in community-level medical institutions.
近期，河北省石家庄市发生了局部聚集性疫情。农村地区未能及时识别发热患者是此次疫情的主要原因。
我们展示了一种新型单管格式实时逆转录重组酶辅助扩增（RT-RAA）试剂盒的现场评估，该评估于2021年1月17日至2021年1月27日在河北省疾病预防控制中心完成。
我们使用808份临床样本的自动提取RNA评估了RT-RAA检测的诊断性能。与逆转录实时定量PCR（qRT-PCR）相比，RT-RAA试剂盒的灵敏度为92.41%，特异性为98.78%，符合率为96.29%，表明RT-RAA检测与qRT-PCR检测具有良好的一致性。此外，58份样本在5分钟内采用手动提取方法进行提取，但仅能稳定检测到核酸浓度高（循环阈值不高于32）的样本。
RT-RAA更适合满足社区级医疗机构快速、灵敏和准确检测的需求。
