Kania Katarzyna, Wójcik Katarzyna, Drożdż Kamil, Klesiewicz Karolina
Department of Pharmaceutical Microbiology, Faculty of Pharmacy, Jagiellonian University Medical College, ul. Medyczna 9, 30-688 Krakow, Poland.
Laboratory of Microbiology, The St. John Paul II Specialist Hospital, ul. Pradnicka 80, 31-202 Krakow, Poland.
Diagnostics (Basel). 2025 Apr 28;15(9):1113. doi: 10.3390/diagnostics15091113.
: Extrapulmonary tuberculosis (TB) presents significant diagnostic challenges, particularly in the context of multidrug-resistant (MDR) strains. This study assessed the utility of the WHO-recommended rapid molecular assays, originally validated for pulmonary TB, in diagnosing extrapulmonary TB and detecting the MDR complex (MTBC). : A total of 6274 clinical samples, including 4891 pulmonary and 1383 extrapulmonary samples, were analyzed between 2019 and 2022 using the BD MAX™ MDR-TB assay (BD MAX), the Xpert MTB/RIF assay (Xpert MTB/RIF), the Xpert MTB/XDR assay (Xpert MTB/XDR), FluoroType MTB, and phenotypic drug susceptibility testing (DST). : MTBC was detected in 426 samples using BD MAX (376 pulmonary and 50 extrapulmonary), of which 277 were culture-confirmed. Phenotypic testing confirmed 299 positive cultures on Löwenstein-Jensen (LJ) medium and 347 in BD BACTEC™ MGIT™ (BACTEC MGIT) mycobacterial growth indicator tube (BBL) liquid culture. BD MAX showed high sensitivity and specificity for extrapulmonary TB detection (93.1% and 98.4%, respectively). Resistance to isoniazid or rifampicin was identified in 11% of MTBC-positive cases, whereas 3.69% were confirmed as MDR-TB. The molecular assays effectively detected resistance-associated mutations , , and ), with high concordance to phenotypic tests (DST) (κ = 0.69-0.89). : This study demonstrates that molecular assays, although validated for pulmonary TB, are also reliable for extrapulmonary TB detection and drug resistance profiling. Their rapid turnaround and robust accuracy support broader implementation in routine diagnostics, especially for challenging extrapulmonary specimens where early detection is critical for targeted therapy.
肺外结核病（TB）带来了重大的诊断挑战，尤其是在耐多药（MDR）菌株的情况下。本研究评估了世界卫生组织推荐的最初用于肺结核验证的快速分子检测方法在诊断肺外结核和检测耐多药复合群（MTBC）方面的效用。：2019年至2022年期间，共分析了6274份临床样本，包括4891份肺部样本和1383份肺外样本，使用了BD MAX™耐多药结核病检测方法（BD MAX）、Xpert MTB/RIF检测方法（Xpert MTB/RIF）、Xpert MTB/XDR检测方法（Xpert MTB/XDR）、FluoroType MTB以及表型药物敏感性检测（DST）。：使用BD MAX在426份样本中检测到MTBC（376份肺部样本和50份肺外样本），其中277份经培养确认。表型检测在罗氏（LJ）培养基上确认了299份阳性培养物，在BD BACTEC™ MGIT™（BACTEC MGIT）分枝杆菌生长指示管（BBL）液体培养中确认了347份。BD MAX对肺外结核检测显示出高敏感性和特异性（分别为93.1%和98.4%）。在11%的MTBC阳性病例中鉴定出对异烟肼或利福平的耐药性，而3.69%被确认为耐多药结核病。分子检测有效地检测到了与耐药相关的突变，与表型检测（DST）具有高度一致性（κ = 0.69 - 0.89）。：本研究表明，分子检测方法虽然是针对肺结核进行验证的，但对于肺外结核检测和耐药性分析也是可靠的。它们快速的周转时间和强大的准确性支持在常规诊断中更广泛地应用，特别是对于具有挑战性的肺外标本，早期检测对于靶向治疗至关重要。
