Accuracy of molecular diagnostic tests for drug-resistant tuberculosis detection in China: a systematic review

Sun, Yixuan; Gao, Le; Xing, Hui; Yang, Zikun; Deng, Siwei; Yang, Jingping; Zhao, Yan; Wang, L; Feng, Jingnan; Huang, Fei; Huan, Shi Tong; Zhan, Siyan

doi:10.5588/ijtld.18.0550

Cited by 5 publications

(3 citation statements)

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“…Furthermore, only one study on TB in Sichuan was conducted with a relatively small sample size ( n = 268) of isolates from January 2008 to May 2010 [ 35 ]. Our findings demonstrated a lower sensitivity but steadier specificity (81.1% and 94.6%, for 2014–2017 [ 3 ] and 79.5% and 96.0%, for 2018–2020) than the findings of the above-mentioned systematic review [ 34 ]. The observed sensitivities in our studies were comparable to those in the United States (81.0%) [ 36 ] and Morocco (78.8%) [ 37 ].…”

Section: Discussioncontrasting

confidence: 58%

“…This rapid detection method is highly accepted by hospitals and patients with TB. In a recent systematic review, it has been reported that the pooled sensitivity and specificity of Xpert for RIF-resistant TB detection in China were 92% and 98%, respectively [ 34 ]. However, recent data from Sichuan Province were not included in this systematic review.…”

Section: Discussionmentioning

confidence: 99%

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Drug resistance characteristics of Mycobacterium tuberculosis isolates obtained between 2018 and 2020 in Sichuan, China

et al. 2022

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We investigated the drug resistance of Mycobacterium tuberculosis isolates from patients with tuberculosis (TB) and HIV, and those diagnosed with only TB in Sichuan, China. TB isolates were obtained from January 2018 to December 2020 and subjected to drug susceptibility testing (DST) to 11 anti-TB drugs and to GeneXpert MTB/RIF testing. The overall proportion of drug-resistant TB (DR-TB) isolates was 32.1% (n=10,946). HIV testing was not universally available for outpatient TB cases, only 29.5% (3,227/10,946) cases had HIV testing results. The observed proportion of multidrugresistant TB (MDR-TB) isolates was almost double than that of the national level, with approximately 1.5% and 0.1% of the isolates being extensively drug resistant and universally drug resistant, respectively. The proportions of resistant isolates were generally higher in 2018 and 2019 than in 2020. Furthermore, the sensitivities of GeneXpert during 2018-2020 demonstrated a downward trend (80.9 [95% confidence intervals (CI): 76.8-85.0], 80.2 [95% CI: 76.4-84.1], and 75.4 [95% CI: 70.7-80.2], respectively). Approximately 69.0% (7,557/10,946) of the TB cases with DST results were subjected to GeneXpert detection. Overall, the DR-TB status and the use of GeneXpert in Sichuan have improved, but DR-TB challenges remain. HIV testing for all TB cases is recommended.

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Section: Discussioncontrasting

confidence: 58%

Section: Discussionmentioning

confidence: 99%

Drug resistance characteristics of Mycobacterium tuberculosis isolates obtained between 2018 and 2020 in Sichuan, China

et al. 2022

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“…However, none of these technologies have been reviewed by WHO, and therefore, uptake by other countries is limited. Table 2 summarizes the performance of some of these assays from systematic reviews ( 38 , 39 ).…”

Section: Emerging Technologiesmentioning

confidence: 99%

Advances in Molecular Diagnosis of Tuberculosis

et al. 2020

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Molecular tests for tuberculosis (TB) have the potential to help reach the three million people with TB who are undiagnosed or not reported each year, and to improve the quality of care TB patients receive by providing accurate, quick results, including rapid drug-susceptibility. The World Health Organization (WHO) has recommended the use of molecular nucleic acid amplification tests (NAATs) tests for TB detection instead of smear microscopy, as they are able to detect TB more accurately, particularly in patients with paucibacillary disease and in people living with HIV. Importantly, some of these WHO-endorsed tests can detect Mycobacterial gene mutations associated with anti-TB drug resistance, allowing for tailoring of effective TB treatment. Currently, a wide array of molecular tests for TB detection is being developed and evaluated, and while some are intended for reference laboratory use, others are being aimed at the point-of-care and peripheral healthcare settings. Notably, there is an emergence of molecular tests designed, manufactured, and rolled out in high TB burden countries, some of which are explicitly aimed for near-patient placement. These developments should increase access to molecular TB testing for larger patient populations. With respect to drug susceptibility testing, NAATs and next generation sequencing can provide results substantially faster than traditional phenotypic culture. Here, we review recent advances and developments in molecular tests for detecting TB as well as anti-TB drug resistance.

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Analysis of the application of a gene chip method for detecting Mycobacterium tuberculosis drug resistance in clinical specimens: a retrospective study

Feng

Han²,

Shi

et al. 2021

Sci Rep

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Most Mycobacterium tuberculosis (Mtb) resistant to rifampicin (RIF) has mutations in the rpoB gene, while most Mtb resistant to isoniazid (INH) has mutations in the katG gene or inhA promoter. We used gene chip technology to detect mutations in these genes to determine the resistance of Mtb to RIF and INH. A total of 4148 clinical specimens with sputum smear positivity for acid-fast bacilli (AFB) were detected. Then, taking the results of the drug sensitivity test (DST) as the reference standard, the detection efficiency of sputum samples from different grades of positive smears was compared in detail. We found that the sensitivity of the gene chip method for detecting sputum samples with a grade ≥ AFB 2 + was higher than that of sputum samples with a grade ≤ AFB 1 + (P < 0.05). When the grade of the sample was ≤ AFB 1 +, the sensitivity of the gene chip method was 72.6% for RIF, 67.3% for INH, and 60.0% for MDR-TB. When the grade of the sample was ≥ AFB 2 +, the sensitivity of the gene chip method was 84.5% for RIF, 78.2% for INH, and 73.9% for MDR-TB. The results show that gene chip technology can be directly used to diagnose drug-resistant tuberculosis in clinical specimens, and the diagnostic efficiency for the detection of sputum specimens with a grade ≥ AFB 2 + is better than that of other sputum specimens.

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Accuracy of molecular diagnostic tests for drug-resistant tuberculosis detection in China: a systematic review

Cited by 5 publications

References 0 publications

Drug resistance characteristics of Mycobacterium tuberculosis isolates obtained between 2018 and 2020 in Sichuan, China

Drug resistance characteristics of Mycobacterium tuberculosis isolates obtained between 2018 and 2020 in Sichuan, China

Advances in Molecular Diagnosis of Tuberculosis

Analysis of the application of a gene chip method for detecting Mycobacterium tuberculosis drug resistance in clinical specimens: a retrospective study

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