Rifampicin-resistant Mycobacterium tuberculosis and unsuccessful results from Xpert® MTB/Rif-Ultra assay in Amhara Region, Ethiopia

IF 1.9 Q3 INFECTIOUS DISEASES

Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Pub Date : 2025-04-25 DOI:10.1016/j.jctube.2025.100528

Gizeaddis Belay , Hailu Getachew , Tigist Birku , Aimro Tadese , Yosef Gashaw , Michael Getie , Tazeb Molla , Molalign Tarekegn , Daniel Mekonnen , Alemayehu Abate

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引用次数: 0

Abstract

Background

Tuberculosis, an infectious disease caused by Mycobacterium tuberculosis (Mtb), causes 10 million new infections and 1.3 million deaths annually. The treatment of TB is hampered by the increasing incidence rate of drug resistance associated with TB. To diagnose TB and identify drug-resistant TB cases, rapid molecular technologies such as Xpert MTB/RIF, Truenat MTB, MTB Plus, and MTB-RIF Dx tests are recommended by the World Health Organization (WHO) and rolled out globally. Xpert MTB/RIF-Ultra assay is the most widely used in developing countries like Ethiopia. However, this rapid technology has inherent limitations, such as error reports, invalid results, and no results collectively reported as unsuccessful tuberculosis results. The purpose of this study was to retrospectively evaluate the trend of rifampicin resistance and unsuccessful results in the Xpert MTB/RIF-Ultra assay facility of Northwest Ethiopia.

Methods

Retrospective data archived in the Amhara Public Health Institute (APHI) TB laboratory from 2019 to 2024 were reviewed. Xpert MTB/RIF-Ultra software data were retrieved and transferred to Microsoft Excel. Then, it was checked for completeness, cleaned manually, and imported to Statistical Package for the Social Sciences (SPSS) version 25 software. The rate of mycobacterium tuberculosis (Mtb.) positives, multi-drug resistance tuberculosis (MDR-TB), and Unsuccessful results were analyzed from the total and year-wise. The final results were depicted using tables and different charts.

Results

From June 30, 2019, to June 30, 2024, a total of 587,128 sputum samples were obtained from presumptive TB patients in 111 GeneXpert sites in the Amhara Region. Of these samples analyzed using Xpert MTB/RIF-Ultra, 6.17 % (36,212/587,128) were Mtb positive. Furthermore, the overall proportion of rifampicin resistance (RR) among Mtb-confirmed cases decreased to 3.03 % (1,096/36,212) and showed a downward trend from 4.62 % (184/3979) in 2020 to 2 % (176/8806) in 2024. The overall unsuccessful results (error, invalid & no result) were 6.48 %. The rate of unsuccessful results remained above the national target of < 5 % throughout the study periods.

Conclusion and recommendation

The rate of Mtb and MDR-TB showed a decreasing trend in the last six years in Northwest Ethiopia. However, unsuccessful results remained above the national target. The cause of unsuccessful results should be investigated, and the Xpert MTB/RIF-Ultra-related quality assurance system must be enhanced to reduce the rate of Xpert MTB/RIF-Ultra unsuccessful results.

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埃塞俄比亚阿姆哈拉地区耐利福平结核分枝杆菌和Xpert®MTB/Rif-Ultra检测结果不成功

结核病是一种由结核分枝杆菌（Mtb）引起的传染病，每年造成1 000万新感染和130万人死亡。与结核病相关的耐药发病率不断上升，阻碍了结核病的治疗。为了诊断结核病和确定耐药结核病病例，世界卫生组织（世卫组织）推荐了快速分子技术，如Xpert MTB/RIF、Truenat MTB、MTB Plus和MTB-RIF Dx检测，并在全球推广。专家MTB/RIF-Ultra检测在埃塞俄比亚等发展中国家使用最为广泛。然而，这种快速的技术具有固有的局限性，例如错误报告、无效结果以及没有结果集体报告为不成功的结核病结果。本研究的目的是回顾性评估埃塞俄比亚西北部Xpert MTB/RIF-Ultra检测设备中利福平耐药趋势和不成功结果。方法回顾性分析Amhara公共卫生研究所（APHI）结核病实验室2019 - 2024年的数据。检索Xpert MTB/RIF-Ultra软件数据并将其传输到Microsoft Excel中。然后，检查它的完整性，手动清理，并导入社会科学统计软件包（SPSS）版本25软件。对结核分枝杆菌（Mtb）阳性率、耐多药结核病（MDR-TB）阳性率和不成功率进行统计分析。最后的结果用表格和不同的图表来描述。结果2019年6月30日至2024年6月30日，在阿姆哈拉地区111个GeneXpert站点共采集了587,128份推定结核病患者的痰样本。在使用Xpert MTB/RIF-Ultra分析的样本中，6.17%（36,212/587,128）为结核分枝杆菌阳性。在结核分枝杆菌确诊病例中，利福平耐药总体比例降至3.03%(1,096/36,212)，并从2020年的4.62%（184/3979）下降至2024年的2%（176/8806）。整体不成功的结果(错误、无效& &；无结果)为6.48%。结果不成功的比率仍然高于国家目标。5%在整个研究期间。结论与建议埃塞俄比亚西北部地区结核分枝杆菌和耐多药结核的发病率在过去6年中呈下降趋势。然而，不成功的结果仍然高于国家目标。调查不合格率的原因，加强Xpert MTB/RIF-Ultra相关的质量保证体系，降低Xpert MTB/RIF-Ultra不合格率。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Clinical Tuberculosis and Other Mycobacterial Diseases Medicine-Pulmonary and Respiratory Medicine

CiteScore

4.00

自引率

5.00%

发文量

审稿时长

30 weeks

期刊介绍： Journal of Clinical Tuberculosis and Mycobacterial Diseases aims to provide a forum for clinically relevant articles on all aspects of tuberculosis and other mycobacterial infections, including (but not limited to) epidemiology, clinical investigation, transmission, diagnosis, treatment, drug-resistance and public policy, and encourages the submission of clinical studies, thematic reviews and case reports. Journal of Clinical Tuberculosis and Mycobacterial Diseases is an Open Access publication.