中国医学装备2025，Vol.22Issue(11)：61-64,4.DOI:10.3969/j.issn.1672-8270.2025.11.009
基于数字PCR平台的肺炎支原体耐药突变检测试剂盒与tNGS在肺炎支原体常见耐药突变检测中的效能对比
A comparative study on the efficacy of detection kit based on digital PCR for drug-resistant mutations of mycoplasma pneumonia and tNGS method in detection for common resistance mutation of mycoplasma pneumonia
摘要
Abstract
Objective:To compare the efficacy of the detection kit based on MicroDrop microdroplet digital PCR platform that can identify mycoplasma pneumonia and common drug-resistance mutation,and throughout targeted next-generation sequencing(tNGS)in detecting common drug-resistance mutations of mycoplasma pneumonia.Methods:A total of 300 samples of clinical respiratory tract of pneumonia inpatients at Guangdong Provincial People's Hospital between 2023 and 2024 were collected.Both the detection kit for drug-resistance mutation of mycoplasma pneumoniae and the tNGS method were employed to detect drug-resistance mutation genes.For samples with inconsistent results,Sanger sequencing was used for verification.Results:For the 300 samples,the detection rates of positive mycoplasma pneumonia of the detection kit for drug-resistance mutation of mycoplasma pneumoniae and the tNGS method were respectively 87.00%and 78.67%,with a Kappa value of 0.711,indicating a relatively high level of agreement between the two methods.Among 25 samples with inconsistent results,Sanger sequencing was employed for validation.The results revealed that for samples with low-frequency gene mutations,the reagent kit maintained reliable detection capability,whereas tNGS exhibited missed detections.Thus,the reagent kit demonstrates superior performance in detecting low-frequency mutation samples.Conclusion:The detection rate of low-frequency mutation samples by the digital PCR-based mycoplasma pneumoniae drug-resistance mutation detection kit is higher than that of the tNGS method.This approach helps enhance the accuracy of detection results,providing a rapid and precise means of detecting drug-resistance genes for clinical diagnosis and treatment.关键词
MicroDrop微滴式数字/聚合酶链式反应(PCR)/肺炎支原体常见耐药突变/耐药突变检测试剂盒/Sanger测序法/病原靶向测序(tNGS)法/低频突变Key words
MicroDrop droplet digital/Polymerase Chain Reaction(PCR)/Common drug-resistant mutations of mycoplasma pneumonia/Detection kit for drug-resistant mutation/Sanger sequencing method/Targeted next-generation sequencing(tNGS)/Low-frequency mutation分类
医药卫生引用本文复制引用
王逍潇,张鑫强,赵云虎,江小珍,陈宗威,王子霞,陈秀贤,顾兵..基于数字PCR平台的肺炎支原体耐药突变检测试剂盒与tNGS在肺炎支原体常见耐药突变检测中的效能对比[J].中国医学装备,2025,22(11):61-64,4.基金项目
国家自然科学基金(82272423,82072380) National Natural Science Foundation of China(82272423,82072380) （82272423,82072380）
