Objective: To evaluate the clinical value of the MeltPro MTB assays in the diagnosis of drug-resistant tuberculosis. Methods: A cross-sectional study design was used to retrospectively collect all 4 551 patients with confirmed tuberculosis between January 2018 and December 2019 at Beijing Chest Hospital, Capital Medical University. Phenotypic drug sensitivity test and GeneXpert MTB/RIF (hereafter referred to as "Xpert") assay were used as gold standards to analyze the accuracy of the probe melting curve method. The clinical value of this technique was also evaluated as a complementary method to conventional assays of drug resistance to increase the detective rate of drug-resistant tuberculosis. Results: By taking the phenotypic drug susceptibility test as the gold standard, the sensitivity of the MeltPro MTB assays to detect resistance to rifampicin, isoniazid, ethambutol and fluoroquinolone was 14/15, 95.7%(22/23), 2/4 and 8/9,respectively; and the specificity was 92.0%(115/125), 93.2%(109/117), 90.4%(123/136) and 93.9%(123/131),respectively; the overall concordance rate was 92.1%(95%CI:89.6%-94.1%),and the Kappa value of the consistency test was 0.63(95%CI:0.55-0.72).By taking the Xpert test results as the reference, the sensitivity of this technology to the detection of rifampicin resistance was 93.6%(44/47), the specificity was100%(310/310), the concordance rate was 99.2%(95%CI:97.6%-99.7%), and the Kappa value of the consistency test was 0.96(95%CI:0.93-0.99). The MeltPro MTB assays had been used in 4 551 confirmed patients; the proportion of patients who obtained effective drug resistance results increased from 83.3% to 87.8%(P<0.01); and detection rate of rifampicin, isoniazid, ethambutol, fluoroquinolone resistance, multidrug and pre-extensive drug resistance cases were increased by 3.2%, 14.7%, 22.2%, 13.7%, 11.2% and 12.5%, respectively. Conclusion: The MeltPro MTB assays show satisfactory accuracy in the diagnosis of drug-resistant tuberculosis. This molecular pathological test is an effective complementary method in improving test positivity of drug-resistant tuberculosis.
目的： 评估探针熔解曲线法检测石蜡包埋组织诊断耐药结核病的临床价值。 方法： 采用横断面研究设计，回顾性收集首都医科大学附属北京胸科医院2018年1月至2019年12月所有确诊结核病住院患者4 551例。以表型药敏试验和GeneXpert结核分枝杆菌及利福平耐药（Xpert MTB/RIF，以下简称“Xpert”）检测为金标准分析探针熔解曲线法的准确性，并评估该技术作为常规耐药诊断方法的补充，提高耐药结核病诊断阳性率的临床价值。 结果： 以表型药敏试验结果为金标准，探针熔解曲线法检测利福平、异烟肼、乙胺丁醇和氟喹诺酮耐药的灵敏度分别为14/15、95.7%（22/23）、2/4、8/9；特异度分别为92.0%（115/125）、93.2%（109/117）、90.4%（123/136）、93.9%（123/131）；总符合率为92.1%（95%CI：89.6%~94.1%），一致性检验Kappa值为0.63（95%CI：0.55~0.72），以Xpert检测结果为标准，该技术对利福平耐药检测的灵敏度为93.6%（44/47），特异度为100%（310/310），符合率为99.2%（95%CI：97.6%~99.7%），一致性检验Kappa值为0.96（95%CI：0.93~0.99）；在4 551例结核病确诊患者中联合应用探针熔解曲线法检测后，获得有效耐药信息的患者比例从83.3%提高到87.8%（P<0.01）；利福平、异烟肼、乙胺丁醇、氟喹诺酮耐药、耐多药以及准广泛耐药检出人数分别增加了3.2%、14.7%、22.2%、13.7%、11.2%以及12.5%。 结论： 探针熔解曲线法进行结核病耐药诊断具有良好的准确性，可以作为常规耐药诊断方法的补充，有效提高耐药结核病诊断阳性率。.