Diagnostic Performance of STANDARD™ M10 Multidrug-resistant Tuberculosis Assay for Detection of Mycobacterium tuberculosis and Rifampicin and Isoniazid Resistance in Zimbabwe.

IF 1.6 Q4 INFECTIOUS DISEASES

International Journal of Mycobacteriology Pub Date : 2024-01-01 Epub Date: 2024-03-15 DOI:10.4103/ijmy.ijmy_194_23

Stephen Stephen, Agrippa Kadye, Xmas Ngoni Majuru, Tariro Madamombe, Janet Sokwe, Tinashe Madondo, Kennedy Tinarwo, Linnience Tsuvani, Takudzwa Kawome, Florence Malunga, Raiva Simbi

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引用次数: 0

Abstract

Background: Although Zimbabwe has transitioned out of the 30 high-burden countries, it still remained in the 30 high multidrug-resistant (MDR)/rifampicin-resistant tuberculosis (TB) burden. Rapid detection of rifampicin (RIF) and isoniazid (INH) is essential for the diagnosis of MDR-TB. The World Health Organization has recommended the use of molecular WHO-recommended rapid diagnostic (mWRD) for TB and DR-TB. STANDARD™ M10 MDR-TB assay is a new molecular rapid diagnostic assay developed by SD Biosensor for the detection of Mycobacterium tuberculosis (MTB) and RIF and INF resistance. This study aims to determine the diagnostic accuracy of STANDARD™ M10 MDR-TB assay.

Methods: The study was conducted on 214 samples with different MTB and RIF and INH resistance status. The STANDARD™ M10 MDR-TB assay was performed according to the manufacturer's instructions. Xpert MTB/RIF Ultra, MGIT culture, and phenotypic drug susceptibility testing are used as comparative methods.

Results: The sensitivity and specificity of STANDARD™ M10 MDR-TB assay for the detection of MTB are 99% and 97.9%, respectively. The sensitivity and specificity of the assay for detection of MDR-TB were 97.8% and 100%, respectively.

Conclusion: The STANDARD™ M10 MDR-TB assay demonstrated high diagnostic accuracy in the detection of MTB and RIF and INH resistance. This molecular assay can also be used as an alternative to other mWRD assays.

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在津巴布韦，STANDARD™ M10 耐多药结核病检测试剂盒在检测结核分枝杆菌及利福平和异烟肼耐药性方面的诊断性能。

背景：尽管津巴布韦已从 30 个结核病高负担国家中脱颖而出，但它仍然是 30 个耐多药（MDR）/耐利福平结核病（TB）高负担国家之一。快速检测利福平（RIF）和异烟肼（INH）是诊断 MDR-TB 的关键。世界卫生组织建议使用世界卫生组织推荐的分子快速诊断法（mWRD）来诊断结核病和耐药结核病。STANDARD™ M10 MDR-TB 检测试剂盒是 SD Biosensor 开发的一种新型分子快速诊断试剂盒，用于检测结核分枝杆菌（MTB）以及 RIF 和 INF 耐药性。本研究旨在确定 STANDARD™ M10 MDR-TB 检测试剂盒的诊断准确性：本研究对 214 份具有不同 MTB 和 RIF 及 INH 耐药性的样本进行了分析。STANDARD™ M10 MDR-TB 检测按照制造商的说明进行。Xpert MTB/RIF Ultra、MGIT 培养和表型药敏试验作为比较方法：STANDARD™ M10 MDR-TB 检测试剂盒检测 MTB 的灵敏度和特异性分别为 99% 和 97.9%。结果：STANDARD™ M10 MDR-TB 检测试剂盒检测 MTB 的灵敏度和特异性分别为 99%和 97.9%，检测 MDR-TB 的灵敏度和特异性分别为 97.8%和 100%：结论：STANDARD™ M10 MDR-TB 检测试剂盒在检测 MTB、RIF 和 INH 耐药性方面具有很高的诊断准确性。该分子检测方法也可用于替代其他 MWRD 检测方法。

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

International Journal of Mycobacteriology Multiple-

CiteScore

2.20

自引率

25.00%

发文量

审稿时长

7 weeks