Ethiopian Public Health Institute, Addis Ababa, Ethiopia.
Department of Microbiology, Immunology, and Parasitology College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.
PLoS One. 2022 Jun 9;17(6):e0269601. doi: 10.1371/journal.pone.0269601. eCollection 2022.
The quality of tuberculosis laboratory services in health facilities is a mandatory component of detecting active pulmonary TB cases and treatment follow-up. However, ensuring the quality of laboratory test results is a concern. This study aimed to assess the quality assurance practices in the tuberculosis diagnostic health facilities of Ethiopia.
A cross-sectional study was conducted from October 2018 to March 2019 at nine governmental TB-culture laboratories and 34 randomly selected GeneXpert® MTB/RIF (Xpert® MTB/RIF) testing health facilities in Ethiopia. Participating health facilities were interviewed and laboratory documents and records present since 2017 were observed. Prior to the data collection, training was given to the data collectors. Descriptive statistics were used to produce results and were presented with tables and graphs.
From a total of 34 Xpert® MTB/RIF testing laboratories, 50% run Internal Quality Control (IQC) for Acid-Fast Bacillus (AFB) Microscopy and 67.6% had lot-to-lot verification of staining reagents. For the Xpert® MTB/RIF assay, a lot-to-lot verification of cartridge and method validation was performed only in 8.8%and 20.6% of Xpert® MTB/RIF testing laboratories respectively. All TB-culture laboratories included in the study ran negative control (start and end IQC) during TB-culture sample processing and performed lot-to-lot verification for Mycobacteria Growth Indicator Tube (MGIT) in 88.9% of TB-culture laboratories. External Quality Assessment (EQA) Proficiency Testing (PT) for AFB microscopy is practiced in 79.4% Xpert® MTB/RIF testing laboratories and 100.0% for the Xpert® MTB/RIF assay. TB-Culture PT participation practice among TB-culture laboratories was 88.9%. A major challenge for health facilities during PT participation was the AFB PT-sample transportation delay (40.7%) and the Xpert® MTB/RIF assay EQA-PT feedback missing (38.2%).
This assessment reveals that IQC for AFB microscopy, lot-to-lot verification, method validation, and equipment calibration were not well-practiced. The majority of TB diagnostic health facility laboratories had EQA-PT participation practice, but a significant gap in PT-sample transportation and missing feedback was identified.
医疗机构的结核病实验室服务质量是发现活动性肺结核病例和治疗随访的强制性组成部分。然而，确保实验室检测结果的质量是一个关注点。本研究旨在评估埃塞俄比亚结核病诊断医疗机构的质量保证实践。
2018 年 10 月至 2019 年 3 月期间，在埃塞俄比亚的 9 个政府结核病培养实验室和 34 个随机选择的 GeneXpert® MTB/RIF（Xpert® MTB/RIF）检测卫生机构进行了横断面研究。对参与的卫生机构进行了访谈，并观察了自 2017 年以来存在的实验室文件和记录。在数据收集之前，对数据收集者进行了培训。使用描述性统计方法生成结果，并以表格和图表形式呈现。
在总共 34 个 Xpert® MTB/RIF 检测实验室中，有 50%的实验室进行了抗酸杆菌（AFB）显微镜内部质量控制（IQC），有 67.6%的实验室对染色试剂进行了批间验证。对于 Xpert® MTB/RIF 检测，只有 8.8%和 20.6%的 Xpert® MTB/RIF 检测实验室分别对试剂盒和方法验证进行了批间验证。所有纳入研究的结核培养实验室在结核培养样本处理过程中均进行了阴性对照（开始和结束 IQC），并对 88.9%的结核培养实验室进行了分枝杆菌生长指示管（MGIT）的批间验证。79.4%的 Xpert® MTB/RIF 检测实验室和 100.0%的 Xpert® MTB/RIF 检测实验室进行了 AFB 显微镜外部质量评估（EQA）能力验证（PT）。结核培养实验室的结核培养 PT 参与率为 88.9%。PT 参与过程中，卫生机构面临的主要挑战是 AFB PT 样本运输延迟（40.7%）和 Xpert® MTB/RIF 检测 EQA-PT 反馈缺失（38.2%）。
本评估显示，AFB 显微镜 IQC、批间验证、方法验证和设备校准的实践情况并不理想。大多数结核病诊断卫生机构都有 EQA-PT 参与实践，但发现了样本运输延迟和反馈缺失的重大差距。
