Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF
Xpert MTB/RIF versus sputum microscopy as the initial diagnostic test for tuberculosis: a cluster-randomised trial embedded in South African roll-out of Xpert MTB/RIF
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DOI：
10.1016/s2214-109x(15)00100-x
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发表时间：
2015-08-01
影响因子：
34.3
通讯作者：
Fielding, Katherine L.
中科院分区：
文献类型：
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作者：
Churchyard, Gavin J.;Stevens, Wendy S.;Fielding, Katherine L.
在南非，痰涂片镜检已被Xpert MTB/RIF取代，作为结核病的初始诊断检测。在一个务实的平行集群随机试验中，我们评估了对患者和程序outcome.Methods的影响，我们随机分配20个实验室（集群）在南非的中等负担地区的Xpert（即时Xpert）或显微镜（Xpert延期）组（1：1），分层省。在每个实验室的两个初级保健诊所，对提供痰液用于结核病调查的成人的系统样本进行合格性评估。主要结局为入组后6个月的死亡率。由于实用的试验设计，不可能掩蔽参与者的组分配。该试验已在ISRCTN注册中心注册（ISRCTN 68905568）和南非临床试验注册中心（DOH-27-1011-3849）.调查结果2012年6月至11月，对4 972人进行了筛查，（93.6%）入组（中位年龄36岁; 2891例[62%]女性; 2212例[62%]报告为HIV阳性）。Xpert组和显微镜组在6个月时的死亡率方面没有差异（分别为91/2324 [3.9%] vs 116/2332 [5.0%];校正风险比[aRR] 1.10，95%CI 0.75-1.62]）。与痰液显微镜相比，Xpert未降低6个月时的死亡率。改善对药物敏感的结核病方案的成果可能不仅需要更好的诊断检测，而且需要更好地与护理挂钩。
Background In South Africa, sputum smear microscopy has been replaced with Xpert MTB/RIF as the initial diagnostic test for tuberculosis. In a pragmatic parallel cluster-randomised trial, we evaluated the effect on patient and programme outcomes.Methods We randomly allocated 20 laboratories (clusters) in medium-burden districts of South Africa to either an Xpert (immediate Xpert) or microscopy (Xpert deferred) group (1: 1), stratified by province. At two primary care clinics per laboratory, a systematic sample of adults giving sputum for tuberculosis investigation was assessed for eligibility. The primary outcome was mortality at 6 months from enrolment. Masking of participants' group allocation was not possible because of the pragmatic trial design. The trial is registered with the ISRCTN registry (ISRCTN68905568) and the South African Clinical Trial Register (DOH-27-1011-3849).Findings Between June and November, 2012, 4972 people were screened, and 4656 (93.6%) enrolled (median age 36 years; 2891 [62%] female; 2212 [62%] reported being HIV-positive). There was no difference between the Xpert and microscopy groups with respect to mortality at 6 months (91/2324 [3.9%] vs 116/2332 [5.0%], respectively; adjusted risk ratio [aRR] 1.10, 95% CI 0.75-1.62]).Interpretation Xpert did not reduce mortality at 6 months compared with sputum microscopy. Improving outcomes in drug-sensitive tuberculosis programmes might require not only better diagnostic tests but also better linkage to care.