Institute of Microbiology and Molecular Genetics, The University of Punjab, Lahore, Pakistan.
Punjab Aids Control Program, Lahore, Pakistan.
J Infect Dev Ctries. 2024 Aug 31;18(8):1241-1248. doi: 10.3855/jidc.18945.
Early diagnosis and successful treatment of drug-resistant tuberculosis (TB) demands rapid, precise, and consistent diagnostic methods to minimise the development of resistance. Therefore, this comparative study was designed to evaluate the diagnostic performance of Xpert (MTB/RIF) and Line probe assay (LPA) for detecting drug-resistant TB.
This study comprised 389 (279 pulmonary and 110 extrapulmonary) samples from patients suspected of having TB. All samples were subjected to Xpert (MTB/RIF), LPA, solid culture, and drug-susceptibility testing. Out of 320 samples, only 180 culture (gold standard) positive were included in the final evaluation. The diagnostic characteristics for methods used were determined by calculating diagnostic sensitivity, specificity, and predictive values. The agreement between all methods was determined by calculating the kappa coefficient.
The sensitivity and specificity for Xpert (MTB/RIF) for detecting TB were 88.5% and 96.4%, respectively, against the solid culture. On the other hand, LPA showed sensitivity and specificity at 94.3% and 100%, respectively. Xpert (MTB/RIF) showed moderate agreement (kappa 0.65, p < 0.01) - (73.3% sensitivity; 97.6% specificity) for the detection of rifampicin resistance. However, LPA achieved better diagnostic accuracy (kappa 0.80, p < 0.01) - (84.6% sensitivity; 98.4% specificity) against drug-resistant TB.
Xpert (MTB/RIF) and LPA have outstanding diagnostic sensitivity and specificity against RIF resistance with a shorter turnaround time, which could result in a substantial therapeutic outcome. Our findings showed LPA superiority over Xpert (MTB/RIF) for drug resistance. However, due to operational challenges, the requirement of technical expertise and infrastructure issues, LPA cannot be used as point-of-care testing in resource-limited countries.
早期诊断和成功治疗耐药结核病(TB)需要快速、准确和一致的诊断方法,以最大限度地减少耐药性的发展。因此,本研究旨在评估 Xpert(MTB/RIF)和线性探针分析(LPA)检测耐药性结核的诊断性能。
本研究纳入了 389 例(279 例肺部和 110 例肺外)疑似结核病患者的样本。所有样本均进行了 Xpert(MTB/RIF)、LPA、固体培养和药敏试验。在 320 个样本中,仅对 180 个培养(金标准)阳性的样本进行了最终评估。通过计算诊断敏感性、特异性和预测值来确定方法的诊断特征。通过计算 Kappa 系数来确定所有方法之间的一致性。
Xpert(MTB/RIF)检测结核的敏感性和特异性分别为 88.5%和 96.4%,与固体培养相比。另一方面,LPA 的敏感性和特异性分别为 94.3%和 100%。Xpert(MTB/RIF)对利福平耐药的检测显示出中等程度的一致性(Kappa 0.65,p<0.01)-(73.3%的敏感性;97.6%的特异性)。然而,LPA 对耐药性结核的诊断准确性更高(Kappa 0.80,p<0.01)-(84.6%的敏感性;98.4%的特异性)。
Xpert(MTB/RIF)和 LPA 对 RIF 耐药具有出色的诊断敏感性和特异性,且具有更短的周转时间,这可能会带来显著的治疗效果。我们的研究结果表明,LPA 优于 Xpert(MTB/RIF)检测耐药性。然而,由于操作挑战、对技术专业知识和基础设施的要求等问题,LPA 不能在资源有限的国家用作床边检测。