Said Bibie, Charlie Loveness, Getachew Emnet, Wanjiru Catherine Lydiah, Abebe Mekdelawit, Manyazewal Tsegahun
Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
Kibong'oto National Tuberculosis Hospital, Kilimanjaro, Tanzania.
SAGE Open Med. 2021 Jul 17;9:20503121211033470. doi: 10.1177/20503121211033470. eCollection 2021.
The lack of rapid, sensitive, and deployable tuberculosis diagnostic tools is hampering the early diagnosis of tuberculosis and early detection of treatment failures. The conventional sputum smear microscopy or Xpert MTB/RIF assay cannot distinguish between alive and dead bacilli and the culture method delays providing results. Tuberculosis molecular bacterial load assay is a reverse transcriptase real-time quantitative polymerase chain reaction that quantifies viable tuberculosis bacillary load as a marker of treatment response for patients on anti-tuberculosis therapy. However, results are not synthesized enough to inform its comparative advantage to tuberculosis culture technique which is yet the gold standard of care. With this review, we searched electronic databases, including PubMed, Embase, and Web of Science, from March 2011 up to February 2021 for clinical trials or prospective cohort studies that compared tuberculosis molecular bacterial load assay with tuberculosis culture in adults. We included eight studies that meet the inclusion criteria. Tuberculosis molecular bacterial load assay surpasses culture in monitoring patients with tuberculosis during the first few weeks of anti-tuberculosis treatment. It is more desirable over culture for its shorter time to results, almost zero rates of contamination, need for less expertise on the method, early rate of decline, lower running cost, and reproducibility. Its rapid and specific tuberculosis treatment monitoring competency benefits patients and healthcare providers to monitor changes of bacillary load among isolates with drug-susceptible or resistance to anti-tuberculosis regimens. Despite of the high installing cost of the tuberculosis molecular bacterial load assay method, molecular expertise, and a well-equipped laboratory, tuberculosis molecular bacterial load assay is a cost-effective method with comparison to culture in operational running. To achieve maximum utility in high tuberculosis burden settings, an intensive initial investment in nucleic acid extraction and polymerase chain reaction equipment, training in procedures, and streamlining laboratory supply procurement systems are crucial. More evidence is needed to demonstrate the potential large-scale and sustainable use of tuberculosis molecular bacterial load assay over culture in resource-constrained settings.
快速、灵敏且可部署的结核病诊断工具的匮乏，正阻碍着结核病的早期诊断以及治疗失败情况的早期发现。传统的痰涂片显微镜检查或Xpert MTB/RIF检测无法区分活菌和死菌，而培养方法会延迟结果的提供。结核病分子细菌载量检测是一种逆转录酶实时定量聚合酶链反应，可将活的结核杆菌载量量化，作为抗结核治疗患者治疗反应的标志物。然而，其结果的综合程度还不足以说明它相对于结核病培养技术（仍是护理的金标准）的比较优势。通过本次综述，我们检索了电子数据库，包括PubMed、Embase和Web of Science，检索时间从2011年3月至2021年2月，以查找比较成人结核病分子细菌载量检测与结核病培养的临床试验或前瞻性队列研究。我们纳入了八项符合纳入标准的研究。结核病分子细菌载量检测在抗结核治疗的最初几周监测结核病患者方面优于培养法。因其出结果时间更短、污染率几乎为零、对该方法所需专业知识较少、下降率早、运行成本较低且具有可重复性，所以比培养法更可取。其快速且特异的结核病治疗监测能力有利于患者和医疗服务提供者监测对结核病治疗方案敏感或耐药的分离株中细菌载量的变化。尽管结核病分子细菌载量检测方法的安装成本高、需要分子专业知识以及配备完善的实验室，但与培养法相比，在实际运行中它是一种具有成本效益的方法。为了在高结核病负担地区实现最大效用，对核酸提取和聚合酶链反应设备进行密集的初始投资、开展程序培训以及简化实验室供应采购系统至关重要。需要更多证据来证明在资源有限的环境中，结核病分子细菌载量检测相对于培养法具有潜在的大规模和可持续使用价值。
