Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and University of Cape Town (UCT) Lung Institute and South African MRC/UCT Centre for the Study of Antimicrobial Resistance, UCT, Cape Town, South Africa.
Centre for Lung Infection and Immunity, Division of Pulmonology, Department of Medicine and University of Cape Town (UCT) Lung Institute and South African MRC/UCT Centre for the Study of Antimicrobial Resistance, UCT, Cape Town, South Africa; Department of Science and Technology-National Research Foundation Centre of Excellence for Biomedical Tuberculosis Research, and South Africa Medical Research Council Centre for Tuberculosis Research, Faculty of Medicine and Health Sciences, Stellenbosch University, Tygerberg, South Africa.
Lancet Glob Health. 2019 Jun;7(6):e798-e807. doi: 10.1016/S2214-109X(19)30164-0.
Rapid on-site diagnosis facilitates tuberculosis control. Performing Xpert MTB/RIF (Xpert) at point of care is feasible, even when performed by minimally trained health-care workers, and when compared with point-of-care smear microscopy, reduces time to diagnosis and pretreatment loss to follow-up. However, whether Xpert is cost-effective at point of care remains unclear.
We empirically collected cost (US$, 2014) and clinical outcome data from participants presenting to primary health-care facilities in four African countries (South Africa, Zambia, Zimbabwe, and Tanzania) during the TB-NEAT trial. Costs were determined using an bottom-up ingredients approach. Effectiveness measures from the trial included number of cases diagnosed, initiated on treatment, and completing treatment. The primary outcome was the incremental cost-effectiveness of point-of-care Xpert relative to smear microscopy. The study was performed from the perspective of the health-care provider.
Using data from 1502 patients, we calculated that the mean Xpert unit cost was lower when performed at a centralised laboratory (Lab Xpert) rather than at point of care ($23·00 [95% CI 22·12-23·88] vs $28·03 [26·19-29·87]). Per 1000 patients screened, and relative to smear microscopy, point-of-care Xpert cost an additional $35 529 (27 054-40 025) and was associated with an additional 24·3 treatment initiations ([-20·0 to 68·5]; $1464 per treatment), 63·4 same-day treatment initiations ([27·3-99·4]; $511 per same-day treatment), and 29·4 treatment completions ([-6·9 to 65·6]; $1211 per completion). Xpert costs were most sensitive to test volume, whereas incremental outcomes were most sensitive to the number of patients initiating and completing treatment. The probability of point-of-care Xpert being cost-effective was 90% at a willingness to pay of $3820 per treatment completion.
In southern Africa, although point-of-care Xpert unit cost is higher than Lab Xpert, it is likely to offer good value for money relative to smear microscopy. With the current availability of point-of-care nucleic acid amplification platforms (eg, Xpert Edge), these data inform much needed investment and resource allocation strategies in tuberculosis endemic settings.
European Union European and Developing Countries Clinical Trials Partnership.
快速现场诊断有助于结核病控制。在护理点进行 Xpert MTB/RIF（Xpert）检测是可行的，即使由训练有素的医疗保健工作者进行，也能缩短诊断时间，并减少治疗前的失访率。然而，在护理点进行 Xpert 是否具有成本效益仍不清楚。
我们从四个非洲国家（南非、赞比亚、津巴布韦和坦桑尼亚）的基层医疗设施参加 TB-NEAT 试验的参与者那里，经验性地收集了成本（2014 年美元）和临床结果数据。成本是通过自下而上的成分法确定的。试验中的有效性指标包括诊断病例数、开始治疗和完成治疗的病例数。主要结果是护理点 Xpert 相对于涂片显微镜的增量成本效益。该研究从医疗保健提供者的角度进行。
根据 1502 名患者的数据，我们计算出在集中式实验室（Lab Xpert）进行 Xpert 的单位成本低于在护理点进行时（$23.00 [95% CI 22.12-23.88] 比 $28.03 [26.19-29.87]）。每筛查 1000 名患者，与涂片显微镜相比，护理点 Xpert 的额外成本为 $35529 （27054-40025），并且与 24.3 例治疗开始相关（[-20.0 至 68.5]；每例治疗 $1464），63.4 例当天开始治疗（[27.3-99.4]；每例当天治疗 $511）和 29.4 例完成治疗（[-6.9 至 65.6]；每例完成治疗 $1211）。Xpert 的成本对检测量最敏感，而增量结果对开始和完成治疗的患者数量最敏感。在愿意支付每例治疗完成 $3820 的情况下，护理点 Xpert 具有成本效益的概率为 90%。
在南部非洲，虽然护理点 Xpert 的单位成本高于实验室 Xpert，但与涂片显微镜相比，它很可能具有良好的性价比。目前，护理点核酸扩增平台（如 Xpert Edge）已经可用，这些数据为结核病流行地区提供了急需的投资和资源分配策略。
欧盟与发展中国家临床试验伙伴关系。
