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Objective <p>To compare the performance of Sanity 2.0 with that of Xpert MTB/RIF and phenotypic drug susceptibility testing (DST) for the detection of <i>Mycobacterium tuberculosis</i> complex (MTBC) and resistance to rifampicin (RIF) and isoniazid (INH).</p> Methods <p>Acid-fast staining positive sputum samples, collected from February to July in 2024, were used for solid culture, DST, Xpert MTB/RIF, and Sanity 2.0 assay.</p> Results <p>The limit of detection of the Sanity 2.0 assay was 3 CFU/mL for MTB detection, and 30 CFU/mL for RIF and INH resistance mutations. Compared to Xpert MTB/RIF, complete agreement was observed for the detection of MTB with sensitivity of 99.3% (296/298), as well as for RIF resistance. Using DST as the reference method, Sanity 2.0 exhibited a sensitivity of 96.55% and a specificity of 99.25% for the detection of RIF resistance. For INH resistance, Sanity 2.0 demonstrated a sensitivity of 78.95% and a specificity of 99.22%. Among three cases with discordant rifampicin resistance profiles between Sanity 2.0 and DST, one Sanity 2.0-sensitive/phenotypically-resistant case was confirmed as sensitive by sequencing, and two Sanity 2.0-resistant/phenotypically-sensitive cases carried a mutation in <i>rpoB</i> at codon 531 (TCG→TTG) and 526 (CAC→AGC), respectively. Among two INH-resistant cases by Sanity 2.0 that were sensitive by DST, one isolate carried a mutation in the <i>ahpC</i> promoter region (–15&#xa0;C &gt; T), and the other had a <i>katG</i> mutation at codon 315 (AGC→ACC). All eight cases that were INH-sensitive by Sanity 2.0 but resistant by DST were confirmed to be sensitive by sequencing.</p> Conclusion <p>Sanity 2.0 represents a rapid and automated molecular assay with high sensitivity for MTBC and RIF/INH resistance detection, showing comparable performance to established assays and making it well-suited for decentralized healthcare settings as a complementary diagnostic tool.</p>

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Simultaneous detection of Mycobacterium tuberculosis complex and rifampin/isoniazid resistance with sanity 2.0 MTBC-MDR: a moderate-complexity automated NAAT

  • 期刊论文

  • 发表日期：

    2026年3月6日

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  • Xichao Ou,
  • Bing Zhao,
  • Hui Xia,
  • Xundi Bao,
  • Dongfang Xu,
  • Qi Ma,
  • Ye Xu,
  • Jingjing Li,
  • Wenzhi Shi,
  • Feina Li,
  • Yajie Guo,
  • Ruida Xing,
  • Yanlin Zhao,
  • Huiwen Zheng

摘要

Objective

To compare the performance of Sanity 2.0 with that of Xpert MTB/RIF and phenotypic drug susceptibility testing (DST) for the detection of Mycobacterium tuberculosis complex (MTBC) and resistance to rifampicin (RIF) and isoniazid (INH).

Methods

Acid-fast staining positive sputum samples, collected from February to July in 2024, were used for solid culture, DST, Xpert MTB/RIF, and Sanity 2.0 assay.

Results

The limit of detection of the Sanity 2.0 assay was 3 CFU/mL for MTB detection, and 30 CFU/mL for RIF and INH resistance mutations. Compared to Xpert MTB/RIF, complete agreement was observed for the detection of MTB with sensitivity of 99.3% (296/298), as well as for RIF resistance. Using DST as the reference method, Sanity 2.0 exhibited a sensitivity of 96.55% and a specificity of 99.25% for the detection of RIF resistance. For INH resistance, Sanity 2.0 demonstrated a sensitivity of 78.95% and a specificity of 99.22%. Among three cases with discordant rifampicin resistance profiles between Sanity 2.0 and DST, one Sanity 2.0-sensitive/phenotypically-resistant case was confirmed as sensitive by sequencing, and two Sanity 2.0-resistant/phenotypically-sensitive cases carried a mutation in rpoB at codon 531 (TCG→TTG) and 526 (CAC→AGC), respectively. Among two INH-resistant cases by Sanity 2.0 that were sensitive by DST, one isolate carried a mutation in the ahpC promoter region (–15 C > T), and the other had a katG mutation at codon 315 (AGC→ACC). All eight cases that were INH-sensitive by Sanity 2.0 but resistant by DST were confirmed to be sensitive by sequencing.

Conclusion

Sanity 2.0 represents a rapid and automated molecular assay with high sensitivity for MTBC and RIF/INH resistance detection, showing comparable performance to established assays and making it well-suited for decentralized healthcare settings as a complementary diagnostic tool.