Keller Sara, Naidoo Kogieleum, Zekarias Medhane, Israel-Isah Sussan, Shaka Mohammed, Gule Gcinile, Naidoo Anushka, Bathnna Miriam, Dlamini-Miti Judith Nomthandazo, Yae Kalkidan, Okpokoro Evaezi, Abimiku Alash'le, Bedru Ahmed, Tiemersma Edine W
KNCV Tuberculosis Foundation, Den Haag, The Netherlands.
Centre for the Aids Programme of Research in South Africa, Durban, KwaZulu-Natal, South Africa.
PLoS One. 2025 Jun 24;20(6):e0326342. doi: 10.1371/journal.pone.0326342. eCollection 2025.
Xpert MTB/XDR (Xpert-XDR) testing can significantly shorten time to initiating appropriate drug-resistant tuberculosis (DR-TB) treatment, but its introduction may impact laboratory workflow, especially in laboratories not currently performing drug susceptibility testing. This study evaluated the feasibility and acceptability of implementing the Xpert-XDR for rapid triage and selection of all-oral regimens for DR-TB.
This was a multi-country, multi-site qualitative study conducted between July and November 2023, as part of the larger TriAD (Triage test for All oral DR TB drugs) study implemented in South Africa, Ethiopia, and Nigeria. We conducted semi-structured in-depth interviews with clinicians, nurses and laboratory staff at each study site until thematic saturation was achieved. Additionally, we interviewed policy makers (n = 9) and people with TB (PWTB) (n = 11), to provide additional insight on the implementation of this new diagnostic assay.
Healthcare workers (n = 61) found the new workflow feasible and acceptable. It was the increased speed in which PWTB would receive a correct diagnosis and appropriate treatment that provided the biggest benefit to moving to Xpert-XDR for healthcare workers and PWTB. Laboratory staff mentioned that Xpert-XDR had expedited and simplified the laboratory workflows. Role-appropriate and ongoing training is a key factor in effective implementation as described by policy makers and healthcare workers alike. Barriers impacting the ability to perform Xpert-XDR included unstable power supply, internet, and temperature control. Additionally, the Xpert MTB/Rif Ultra test has higher sensitivity for the detection of TB than the Xpert-XDR test, leading to discordant test results.
This study showed that implementation of Xpert-XDR in health facilities is both feasible and acceptable by all types of healthcare workers. Some barriers with Xpert-XDR are not exclusive to this particular diagnostic tool but are important to address when policy makers are deciding which tools to implement.
Xpert MTB/XDR(Xpert-XDR)检测可显著缩短启动适当耐多药结核病(DR-TB)治疗的时间,但其引入可能会影响实验室工作流程,尤其是在目前未开展药敏试验的实验室。本研究评估了实施Xpert-XDR用于DR-TB快速分诊和选择全口服治疗方案的可行性和可接受性。
这是一项在2023年7月至11月期间开展的多国家、多地点定性研究,是在南非、埃塞俄比亚和尼日利亚实施的更大规模的TriAD(全口服DR-TB药物分诊检测)研究的一部分。我们在每个研究地点对临床医生、护士和实验室工作人员进行了半结构化深入访谈,直至达到主题饱和。此外,我们还采访了政策制定者(n = 9)和结核病患者(PWTB)(n = 11),以获取关于这种新诊断检测方法实施的更多见解。
医护人员(n = 61)认为新的工作流程可行且可接受。对医护人员和结核病患者而言,转向Xpert-XDR带来的最大益处是结核病患者能更快获得正确诊断和适当治疗。实验室工作人员提到Xpert-XDR加快并简化了实验室工作流程。正如政策制定者和医护人员所描述的,进行适当且持续的培训是有效实施的关键因素。影响开展Xpert-XDR检测能力的障碍包括电力供应不稳定、网络和温度控制问题。此外,Xpert MTB/Rif Ultra检测对结核病的检测灵敏度高于Xpert-XDR检测,导致检测结果不一致。
本研究表明,在医疗机构中实施Xpert-XDR对各类医护人员来说都是可行且可接受的。Xpert-XDR存在的一些障碍并非该特定诊断工具所独有,但在政策制定者决定实施哪些工具时,解决这些问题很重要。