Raizada Neeraj, Sachdeva Kuldeep Singh, Sreenivas Achuthan, Kulsange Shubhangi, Gupta Radhey Shyam, Thakur Rahul, Dewan Puneet, Boehme Catharina, Paramsivan Chinnambedu Nainarappan
Foundation for Innovative New Diagnostics, New Delhi, India.
Central TB Division, Government of India, New Delhi, India.
PLoS One. 2015 Feb 6;10(2):e0116721. doi: 10.1371/journal.pone.0116721. eCollection 2015.
A critical challenge in providing TB care to People Living with HIV (PLHIV) is establishing an accurate bacteriological diagnosis. Xpert MTB/RIF, a highly sensitive and specific rapid tool, offers a promising solution in addressing these challenges. This study presents results from PLHIV taking part in a large demonstration study across India wherein upfront Xpert MTB/RIF testing was offered to all presumptive PTB cases in public health facilities.
The study covered a population of 8.8 million across 18 sub-district level tuberculosis units (TU), with one Xpert MTB/RIF platform established at each TU. All HIV-infected patients suspected of TB (both TB and Drug Resistant TB (DR-TB)) accessing public health facilities in study area were prospectively enrolled and provided upfront Xpert MTB/RIF testing.
2,787 HIV-infected presumptive pulmonary TB cases were enrolled and 867 (31.1%, 95% Confidence Interval (CI) 29.4‒32.8) HIV-infected TB cases were diagnosed under the study. Overall 27.6% (CI 25.9-29.3) of HIV-infected presumptive PTB cases were positive by Xpert MTB/RIF, compared with 12.9% (CI 11.6-14.1) who had positive sputum smears. Upfront Xpert MTB/RIF testing of presumptive PTB and DR-TB cases resulted in diagnosis of 73 (9.5%, CI 7.6‒11.8) and 16 (11.2%, CI 6.7‒17.1) rifampicin resistance cases, respectively. Positive predictive value (PPV) for rifampicin resistance detection was high 97.7% (CI 89.3‒99.8), with no significant difference with or without prior history of TB treatment.
The study results strongly demonstrate limitations of using smear microscopy for TB diagnosis in PLHIV, leading to low TB and DR-TB detection which can potentially lead to either delayed or sub-optimal TB treatment. Our findings demonstrate the usefulness and feasibility of addressing this diagnostic gap with upfront of Xpert MTB/RIF testing, leading to overall strengthening of care and support package for PLHIV.
为感染艾滋病毒的人(PLHIV)提供结核病护理面临的一项关键挑战是进行准确的细菌学诊断。Xpert MTB/RIF是一种高度灵敏且特异的快速检测工具,为应对这些挑战提供了一个有前景的解决方案。本研究展示了参与印度一项大型示范研究的PLHIV的研究结果,该研究中对公共卫生机构中所有疑似肺结核病例均进行了Xpert MTB/RIF检测。
该研究覆盖了18个分区级结核病防治单位(TU)的880万人口,每个TU都设立了一个Xpert MTB/RIF检测平台。所有在研究区域内进入公共卫生机构的疑似结核病(包括结核病和耐多药结核病(DR-TB))的艾滋病毒感染患者均被前瞻性纳入研究,并接受了Xpert MTB/RIF检测。
共纳入2787例艾滋病毒感染的疑似肺结核病例,研究期间诊断出867例(31.1%,95%置信区间(CI)29.4‒32.8)艾滋病毒感染的结核病病例。总体而言,Xpert MTB/RIF检测显示27.6%(CI 25.9-29.3)的艾滋病毒感染疑似肺结核病例呈阳性,而痰涂片阳性的比例为12.9%(CI 11.6-14.1)。对疑似肺结核和耐多药结核病病例进行Xpert MTB/RIF检测,分别诊断出73例(9.5%,CI 7.6‒11.8)和16例(11.2%,CI 6.7‒17.1)利福平耐药病例。利福平耐药检测的阳性预测值(PPV)很高,为97.7%(CI 89.3‒99.8),有无结核病治疗史之间无显著差异。
研究结果有力地证明了在PLHIV中使用涂片显微镜检查进行结核病诊断存在局限性,导致结核病和耐多药结核病的检测率较低,这可能会导致结核病治疗延迟或不充分。我们的研究结果表明,通过Xpert MTB/RIF检测来填补这一诊断空白是有用且可行的,从而全面加强了对PLHIV的护理和支持方案。