Diagnostic performance of STANDARD™ M10 multidrug-resistant tuberculosis assay for detection of Mycobacterium tuberculosis and rifampicin and isoniazid resistance in zimbabwe

被引：3
作者：
Stephen, Stephen [1 ]
Kadye, Agrippa [1 ]
Majuru, Xmas Ngoni [1 ]
Madamombe, Tariro [1 ]
Sokwe, Janet [1 ]
Madondo, Tinashe [1 ]
Tinarwo, Kennedy [1 ]
Tsuvani, Linnience [1 ]
Kawome, Takudzwa [1 ]
Malunga, Florence [1 ]
Simbi, Raiva [2 ]
机构：
[1] Sally Mugabe Cent Hosp, Natl Microbiol Reference Lab TB NMRL TB, Lobengula St, Southerton, Zimbabwe
[2] Minist Hlth & Child Care, Directorate Lab Serv, Kaguvi Bldg,Fourth St, Harare, Zimbabwe
来源：
INTERNATIONAL JOURNAL OF MYCOBACTERIOLOGY | 2024年 / 13卷 / 01期
关键词：
Molecular WHO-recommended rapid diagnostic; multidrug-resistant tuberculosis; Mycobacterium tuberculosis; STANDARD (TM) M10; XPERT MTB/RIF ULTRA; LINE PROBE ASSAY; SPUTUM;
D O I：
10.4103/ijmy.ijmy_194_23
中图分类号：
R51 [传染病];
学科分类号：
100401 ;
摘要：
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 (TM) 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 (TM) M10 MDR-TB assay. Methods: The study was conducted on 214 samples with different MTB and RIF and INH resistance status. The STANDARD (TM) 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 (TM) 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 (TM) 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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页码：22 / 27
页数：6
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