Rahman S M Mazidur, Ather Md Fahim, Nasrin Rumana, Hoque Mohammad Ariful, Khatun Razia, Rahman Tanjina, Uddin Mohammad Khaja Mafij, Ahmed Shahriar, Banu Sayera
Infectious Diseases Division, International Centre for Diarrhoeal Disease Research, Dhaka 1212, Bangladesh.
Diagnostics (Basel). 2022 Feb 5;12(2):410. doi: 10.3390/diagnostics12020410.
The fast and accurate detection of susceptibility in drugs is a major challenge for a successful tuberculosis (TB) control programme. This study evaluated the performance of WHO-endorsed rapid diagnostic tools, such as BACTEC MGIT 960 SIRE (MGIT SIRE), GenoType MTBDR (MTBDR) and Xpert MTB/RIF (Xpert), for detecting susceptibility to first-line anti-TB drugs among pulmonary TB patients in Bangladesh. A total of 825 sputum samples with results from drug susceptibility testing (DST) against first-line anti-TB drugs in the MGIT SIRE, MTBDR and Xpert assays were evaluated and compared with the gold standard proportion susceptibility method of the Lowenstein-Jensen (LJ) medium. The overall sensitivities of MGIT SIRE were 97.6%, 90.0%, 61.3% and 44.9%, while specificities were 89.9%, 94.5%, 91.3% and 92.2% for detection of susceptibility to isoniazid (INH), rifampicin (RIF), streptomycin (STR) and ethambutol (EMB), respectively. For MTBDR, the sensitivities were 88.0% and 88.7%, and the specificities were 97.4% and 97.8% for the detection of susceptibility to INH and RIF, respectively. Xpert demonstrated a sensitivity and specificity of 94.8% and 99.5%, respectively, for the detection of RIF susceptibility. All tests performed significantly better in retreated TB patients compared with primary TB cases. For detection of RIF and INH susceptibility, all three assays showed almost perfect agreement with the LJ method, although MGIT SIRE exhibited low agreement for STR and EMB. Considering the high performance, shorter turnaround time and ease of use, molecular-based approaches Xpert and MTBDR can be widely implemented throughout the country for the rapid detection of drug-resistant TB.
快速准确地检测药物敏感性是成功控制结核病（TB）项目面临的一项重大挑战。本研究评估了世界卫生组织认可的快速诊断工具，如BACTEC MGIT 960 SIRE（MGIT SIRE）、GenoType MTBDR（MTBDR）和Xpert MTB/RIF（Xpert），在孟加拉国肺结核患者中检测一线抗结核药物敏感性的性能。共评估了825份痰标本，这些标本在MGIT SIRE、MTBDR和Xpert检测中进行了一线抗结核药物药敏试验（DST），并与罗氏（LJ）培养基的金标准比例药敏方法进行了比较。MGIT SIRE检测异烟肼（INH）、利福平（RIF）、链霉素（STR）和乙胺丁醇（EMB）敏感性的总体敏感性分别为97.6%、90.0%、61.3%和44.9%，特异性分别为89.9%、94.5%、91.3%和92.2%。对于MTBDR，检测INH和RIF敏感性的敏感性分别为88.0%和88.7%，特异性分别为97.4%和97.8%。Xpert检测RIF敏感性的敏感性和特异性分别为94.8%和99.5%。与初治结核病例相比，所有检测在复治结核患者中表现明显更好。对于检测RIF和INH敏感性，尽管MGIT SIRE对STR和EMB的一致性较低，但所有三种检测方法与LJ方法几乎完全一致。考虑到高性能、较短的周转时间和易用性，基于分子的方法Xpert和MTBDR可在全国广泛应用于快速检测耐多药结核病。
