Yang Chenglin, Wang Ziyi, Kong Lingjun, Du Juan, Yi Jie
Department of Clinical Laboratory, Peking Union Medical College Hospital, No.1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, 100730, China.
AMB Express. 2024 Dec 18;14(1):134. doi: 10.1186/s13568-024-01782-5.
During the 2023 autumn-winter period in China, Mycoplasma pneumoniae (MP) infections have increased. To address this, rapid and accurate MP DNA detection methods are crucial. Three nucleic acid detection assays (Ustar, Coyote Flash10, Coyote Flash 20) that are widely used in China are currently being evaluated for their effectiveness in detecting MP DNA in nasopharyngeal specimens. Reference standard materials for MP and a total of 35 NPS collected from Peking Union Medical College Hospital were tested using the Ustar, Coyote Flash10 and Coyote Flash 20 assays to assess analytical sensitivity, analytical specificity, diagnostic performance and workflow. The assays showed differing limits of detection (LOD) based on the absolute quantification of reference standards, with LODs of 500 copies/mL for the Ustar assays and 200 copies/mL for both Coyote Flash10 and Coyote Flash 20 assays. Additionally, all three assays displayed excellently analytical specificity in detecting MP DNA.The clinical correlation analysis demonstrated that the Ustar assay exhibited a sensitivity of 90.00%, specificity of 100%, positive predictive value (PPV) of 100%, and negative predictive value (NPV) of 62.50%. In contrast, both the Coyote Flash10 and Coyote Flash 20 assays displayed perfect diagnostic accuracy with 100% sensitivities, specificities, PPVs, and NPVs. Despite variations in detection principles, sample volume, and pre-preparation among the three assays, they all had a turnaround time of less than 30 min with low-throughput processing. Overall, all three rapid nucleic acid detection assays displayed excellent clinical performance in detecting MP DNA, offering a solid foundation for the quick clinical diagnosis of MP infection.
在中国2023年秋冬期间，肺炎支原体（MP）感染有所增加。为应对这一情况，快速准确的MP DNA检测方法至关重要。目前正在评估在中国广泛使用的三种核酸检测方法（Ustar、Coyote Flash10、Coyote Flash 20）在检测鼻咽标本中MP DNA的有效性。使用Ustar、Coyote Flash10和Coyote Flash 20检测方法对MP参考标准物质以及从北京协和医院收集的35份鼻咽拭子进行检测，以评估分析灵敏度、分析特异性、诊断性能和工作流程。根据参考标准的绝对定量，这些检测方法显示出不同的检测限（LOD），Ustar检测方法的LOD为500拷贝/毫升，Coyote Flash10和Coyote Flash 20检测方法的LOD均为200拷贝/毫升。此外，所有三种检测方法在检测MP DNA时均表现出出色的分析特异性。临床相关性分析表明，Ustar检测方法的灵敏度为90.00%，特异性为100%，阳性预测值（PPV）为100%，阴性预测值（NPV）为62.50%。相比之下，Coyote Flash10和Coyote Flash 20检测方法均显示出完美的诊断准确性，灵敏度、特异性、PPV和NPV均为100%。尽管这三种检测方法在检测原理、样本量和预处理方面存在差异，但它们在低通量处理下的周转时间均不到30分钟。总体而言，所有三种快速核酸检测方法在检测MP DNA方面均表现出出色的临床性能，为MP感染的快速临床诊断提供了坚实基础。
