An automated rapid molecular diagnostic kit (Smart Gene Myco) was recently developed for individual detection of Mycoplasma pneumoniae (MP) genes. This new testing approach requires no special equipment and skills and can be completed within 50 min. We prospectively evaluated this diagnostic kit, along with other conventional tests, for pneumonia diagnosis in children. Samples from 98 children (50 boys and 48 girls; aged 1–14 years; mean: 4.7 ± 2.1 years; median: 4 years) clinically diagnosed with pneumonia were tested for MP using real-time polymerase chain reaction (RT-PCR) as a reference method. Results from three molecular diagnostic tests, serum anti-MP antibodies, and MP culture were compared to RT-PCR data. Among the 98 children, 38 were positive for MP. All molecular diagnostic results showed complete concordance with the RT-PCR data. The sensitivity of the culture was 64%, whereas the sensitivities of the ImmunoCard Mycoplasma and SERODIA Myco II kits were lower (39% and 29%, respectively). Furthermore, a significant positive correlation was found between MP copy numbers and the culture test sensitivity (r = 0.95, p = 0.048). Macrolide-resistance mutations in the 23S ribosomal RNA gene were detected in 24 of 38 children using Smart Gene Myco based on quenching-probe PCR, which was confirmed by direct sequencing, revealing all mutations as A2063G. This is the first study to evaluate the clinical utility of the Smart Gene Myco kit, demonstrating that it is a fast and reliable method to support timely therapeutic decisions in children with MP pneumonia.

最近开发了一种自动化快速分子诊断试剂盒（Smart Gene Myco），用于肺炎支原体的个体检测(MP) 基因。这种新的测试方法不需要特殊的设备和技能，可以在 50 分钟内完成。我们前瞻性地评估了该诊断试剂盒以及其他常规测试，用于儿童肺炎诊断。使用实时聚合酶链反应 (RT-PCR) 对来自临床诊断为肺炎的 98 名儿童（50 名男孩和 48 名女孩；1-14 岁；平均：4.7 ± 2.1 岁；中位数：4 岁）的样本进行 MP 检测一个参考方法。将三项分子诊断测试、血清抗 MP 抗体和 MP 培养的结果与 RT-PCR 数据进行比较。在 98 名儿童中，38 名 MP 呈阳性。所有分子诊断结果均与 RT-PCR 数据完全一致。培养的敏感性为 64%，而 ImmunoCard Mycoplasma 和 SERODIA Myco II 试剂盒的敏感性较低（分别为 39% 和 29%）。此外，在 MP 拷贝数和培养试验敏感性之间发现了显着的正相关（r  = 0.95，p  = 0.048）。使用基于淬灭探针 PCR 的 Smart Gene Myco 在 38 名儿童中的 24 名中检测到23S核糖体 RNA 基因中的大环内酯抗性突变，经直接测序证实，所有突变均为 A2063G。这是第一项评估 Smart Gene Myco 试剂盒临床效用的研究，证明它是一种快速可靠的方法，可以支持儿童 MP 肺炎的及时治疗决策。