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荧光PCR探针熔解曲线技术测定痰液标本中结核分枝杆菌对异烟肼耐药性的临床效能

Clinical performance of fluorescent PCR probe melting curve technology in detecting isoniazid resistance of Mycobacterium tuberculosis in sputum specimens
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摘要 目的探讨荧光PCR探针熔解曲线技术测定痰液标本中结核分枝杆菌(MTB)对异烟肼耐药性的临床效能。方法选择2023年1月至2024年12月郑州市第六人民医院收治的187例疑似肺结核患者,采用荧光PCR探针熔解曲线技术(MeltPro)检测痰标本中MTB对异烟肼的耐药性,同时以比例法药敏试验(L-J培养基)为金标准,根据检测结果分为耐药组和敏感组,分析MeltPro技术在临床耐药结核快速诊断中的应用价值。结果以比例法药敏试验(L-J培养基)为金标准,187例疑似肺结核患者痰标本中MTB对异烟肼耐药性阳性(耐药)50例,阴性(敏感)137例。MeltPro检测痰标本中MTB对异烟肼耐药性的诊断效能灵敏度、特异度、准确度较高,均>90%,检测痰标本中MTB对异烟肼耐药性的结果与金标准的一致性Kappa值较高,大于0.8。结论MeltPro在痰液标本中直接检测MTB对异烟肼耐药性诊断效能较高,可作为临床快速筛查异烟肼耐药性的可靠方法。 Objective To evaluate the clinical performance of fluorescent PCR probe melting curve technology(MeltPro)in detecting isoniazid(INH)resistance of Mycobacterium tuberculosis(MTB)in sputum specimens.Methods A total of 187 patients with suspected pulmonary tuberculosis from January 2023 to December 2024 at The Sixth People's Hospital of Zhengzhou were enrolled.The MeltPro assay was used to detect INH resistance in sputum specimens,with the proportion method drug susceptibility test(L-J medium)as the gold standard.Based on the results,patients were divided into a resistant group and a susceptible group to analyze the diagnostic value of MeltPro in the rapid detection of drug-resistant tuberculosis.Results Using the proportion method(L-J medium)as the reference standard,50 cases were INH-resistant(positive)and 137 were INH-susceptible(negative)among the 187 sputum specimens.The MeltPro assay demonstrated high diagnostic performance,with sensitivity,specificity,and accuracy all exceeding 90%.The consistency between MeltPro and the gold standard was excellent,with a Kappa value>0.8.Conclusion The MeltPro assay exhibits high diagnostic efficiency in directly detecting INH resistance in sputum specimens and can serve as a reliable method for rapid clinical screening of INH-resistant MTB.
作者 吕萌萌 许少莉 孔庆飞 可春梅 赵石磊 LYU Mengmeng;XU Shaoli;KONG Qingfei;KE Chunmei;ZHAO Shilei(Department of Clinical Laboratory,The Sixth People's Hospital of Zhengzhou,Zhengzhou Henan 450000,China)
出处 《天津药学》 2025年第6期723-726,共4页 Tianjin Pharmacy
基金 郑州市科技局创新指导项目(2024YLZDJH386)。
关键词 结核分枝杆菌 荧光PCR探针熔解曲线技术 异烟肼 耐药 Mycobacterium tuberculosis Fluorescent PCR probe melting curve technology Isoniazid Drug resistance
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