Clinical Evaluation of a Novel Point-of-Care Assay To Detect Mycoplasma pneumoniae and Associated Macrolide-Resistant Mutations
Clinical Evaluation of a Novel Point-of-Care Assay To Detect Mycoplasma pneumoniae and Associated Macrolide-Resistant Mutations
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DOI：
10.1128/jcm.03245-20
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发表时间：
2021-07-01
影响因子：
9.4
通讯作者：
Matsuo, Muneaki
中科院分区：
文献类型：
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作者：
Kakiuchi, Toshihiko;Miyata, Ippei;Matsuo, Muneaki
最近在亚洲大环内酯类耐药肺炎支原体的增加已成为一个持续的问题。一种即时检测方法，可以快速检测M。肺炎和大环内酯耐药突变（MR突变）对于正确使用抗菌药物至关重要。Smart Gene（瑞穗梅迪公司，有限公司、Tosu City，佐贺，日本）是一种紧凑且廉价的全自动基因分析仪，它结合了PCR扩增和淬灭探针方法，可同时指定基因和MR突变。我们在疑似M的儿科患者中对该器械及其试剂进行了临床评价。pneumoniae呼吸道感染，并评价了该测定法对抗菌剂选择的影响。以实时荧光定量PCR为对照，Smart Gene的敏感性为97.8%（44/45），特异性为93.3%（98/105），总符合率为94.7%（142/150）。Smart Gene诊断MR突变与序列分析的总体符合率为100%（48/48）。高水平医疗机构的MR突变率明显高于基层医疗诊所（P = 0.023），MR突变患者中抗生素治疗改为大环内酯类药物的情况明显更常见（P = 0.00024）。Smart Gene在M.在社区获得性肺炎护理中发挥核心作用的基层医疗机构，使用这种设备可以减少因呼吸道感染而转诊到高级医疗机构的情况，从而减轻患者的医疗和经济负担。
The recent increase in macrolide-resistant Mycoplasma pneumoniae in Asia has become a continuing problem. A point-of-care testing method that can quickly detect M. pneumoniae and macrolide-resistant mutations (MR mutations) is critical for proper antimicrobial use. Smart Gene (Mizuho Medy Co., Ltd., Tosu City, Saga, Japan) is a compact and inexpensive fully automatic gene analyzer that combines amplification with PCR and the quenching probe method to specify the gene and MR mutations simultaneously. We performed a clinical evaluation of this device and its reagents on pediatric patients with suspected M. pneumoniae respiratory infections and evaluated the impact of the assay on antimicrobial selection. Using real-time PCR as a comparison control, the sensitivity of Smart Gene was 97.8% (44/45), its specificity was 93.3% (98/105), and its overall concordance rate was 94.7% (142/150). The overall concordance rate of Smart Gene diagnosis of MR mutations in comparison with sequence analysis was 100% (48/48). The ratio of MR mutations was significantly higher at high-level medical institutions than at a primary medical clinic (P = 0.023), and changes in antibiotic therapy to drugs other than macrolides were significantly more common in patients with MR mutations (P = 0.00024). Smart Gene demonstrated excellent utility in the diagnosis of M. pneumoniae and the selection of appropriate antimicrobials for MR mutations at primary medical institutions, which play a central role in community-acquired pneumonia care. The use of this device may reduce referrals to high-level medical institutions for respiratory infections, thereby reducing the medical and economic burdens on patients.