背景:结核病(TB)仍然是仅次于COVID-19的全球第二大死亡病原体。它是由结核分枝杆菌(MTB)感染引起的。
目的:本研究的目的是比较GeneNAT实时聚合酶链反应分析仪和预加载的基于芯片的MTB筛查和耐多药结核病(MDR-TB)检测试剂盒(SmartSureTMMTB&MDR-TB,GenetixBiotechAsiaPvt.Ltd.,新德里,印度)针对已建立的WHO批准的GeneXpertUltra(MTB/利福平(RIF)),线探针测定(LPA),和分枝杆菌生长指示管(MGIT)培养在护理点(POC)水平。
方法:从2023年10月至2024年3月,在中间参考实验室共招募了450名肺结核(PTB)可疑患者,医学部,全印度医学科学研究所,新德里,印度。GeneXpert和GeneNAT测试直接从痰标本进行。然而,经处理的痰标本用于LPA(GenoTypeMTBDRplus)和液体培养及药敏试验(MGIT培养及药敏试验(DST)).
结果:与GeneXpert相比,用于检测MTB和利福平(RIF),SmartSureTM的灵敏度分别为98.18%和97.5%,特异性为100%和98.92%,分别。在比较rpoB基因与LPA的突变时,SmartSureTMMDR-TB试剂盒的敏感性和特异性分别为96.77%和99.12%,分别。对于katG和inhA基因,敏感性和特异性分别为97.6%和85.71%和98.66%和98.01%,分别,这两个基因。SmartSureTMMDR-TB显示出与MGIT-DST相当的结果,灵敏度和特异性分别为96.88%和96.15%和98.99%和99.02%,分别,RIF和异烟肼(INH)药物。
结论:GeneNAT系统测试可以在使用最少标本的情况下在短时间内提供PTB病例中RIF和INH抵抗的状态。与在结核病和耐药结核病负担资源有限的国家使用的世卫组织批准的其他诊断方法相比,它所需的基础设施很少,实验室工作人员技能较低。
BACKGROUND: Tuberculosis (TB) is still the second causative agent of death worldwide after COVID-19. It is caused by Mycobacterium tuberculosis (MTB) infection.
OBJECTIVE: The aim of the current study was to compare the performance of GeneNAT real-time polymerase chain reaction analyzer and pre-loaded chip-based MTB screening and multidrug-resistant tuberculosis (MDR-TB) detection kit (Smart SureTM MTB & MDR-TB, Genetix Biotech Asia Pvt. Ltd., New Delhi, India) against the established WHO-approved GeneXpert Ultra (MTB/rifampicin (RIF)), line probe assay (LPA), and mycobacteria growth indicator tube (MGIT) culture at point of care (POC) level.
METHODS: A total of 450 pulmonary TB (PTB) suspect patients were enrolled from October 2023 to March 2024 at the Intermediate Reference Laboratory, Department of Medicine, All India Institute of Medical Sciences, New Delhi, India. GeneXpert and GeneNAT tests were done directly from sputum specimens. However, processed sputum specimens were used for both LPA (GenoType MTBDRplus) and liquid culture and drug susceptibility testing (MGIT culture and drug susceptibility testing (DST)).
RESULTS: On comparing with GeneXpert, for the detection of MTB and rifampicin (RIF), Smart SureTM showed a sensitivity of 98.18% and 97.5% with a specificity of 100% and 98.92%, respectively. While comparing mutations in the rpoB gene with LPA, the Smart SureTM MDR-TB kit exhibited sensitivity and specificity of 96.77% and 99.12%, respectively. For katG and inhA genes, sensitivity and specificity were 97.6% & 85.71% and 98.66% & 98.01%, respectively, for both genes. Smart SureTM MDR-TB showed comparable results with MGIT-DST with sensitivity and specificity of 96.88% & 96.15% and 98.99% & 99.02%, respectively, for both RIF and isoniazid (INH) drugs.
CONCLUSIONS: The GeneNAT system test may provide the status of RIF and INH resistance in PTB cases in a short time with the use of minimal specimens. It required very little infrastructure with less skilled laboratory staff in comparison with other WHO-approved diagnostics used in resource-limited countries with TB and drug-resistant TB burdens.