Clinical value of the MeltPro MTB assays in detection of drug-resistant tuberculosis in paraffin-embedded tissues.
10.3760/cma.j.cn112151-20230103-00004
- VernacularTitle: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
- Author:
Jia Lu CHE
1
;
Zi Chen LIU
1
;
Kun LI
1
;
Wei Li DU
1
;
Dan ZHAO
1
;
Jing MU
1
;
Yu Jie DONG
1
;
Nan Ying CHE
1
Author Information
1. Department of Pathology, Beijing Key Laboratory for Drug Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149,China.
- Publication Type:Journal Article
- MeSH:
Humans;
Rifampin/therapeutic use*;
Antibiotics, Antitubercular/therapeutic use*;
Mycobacterium tuberculosis;
Ethambutol/pharmacology*;
Isoniazid/pharmacology*;
Paraffin Embedding;
Retrospective Studies;
Cross-Sectional Studies;
Drug Resistance, Bacterial;
Sensitivity and Specificity;
Tuberculosis, Multidrug-Resistant/drug therapy*
- From:
Chinese Journal of Pathology
2023;52(5):466-471
- CountryChina
- Language:Chinese
-
Abstract:
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.
