Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study
ABSTRACTEarly and accurate diagnosis of tuberculosis (TB) is necessary to initiate proper therapy for the benefit of the patients and to prevent disease transmission in the community. In this study, we developed the InnowaveDX MTB/RIF (InnowaveDX) to detect Mycobacterium tuberculosis (MTB) and rifam...
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | Emerging Microbes and Infections |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/22221751.2022.2151382 |
| _version_ | 1797652825295028224 |
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| author | Yunfeng Deng Zichun Ma Biyi Su Guanghong Bai Jianhua Pan Quan Wang Long Cai Yanhua Song Yuanyuan Shang Pinyun Ma Jing Li Qianxuan Zhou Gulibike Mulati Dapeng Fan Shanshan Li Yaoju Tan Yu Pang |
| author_facet | Yunfeng Deng Zichun Ma Biyi Su Guanghong Bai Jianhua Pan Quan Wang Long Cai Yanhua Song Yuanyuan Shang Pinyun Ma Jing Li Qianxuan Zhou Gulibike Mulati Dapeng Fan Shanshan Li Yaoju Tan Yu Pang |
| author_sort | Yunfeng Deng |
| collection | DOAJ |
| description | ABSTRACTEarly and accurate diagnosis of tuberculosis (TB) is necessary to initiate proper therapy for the benefit of the patients and to prevent disease transmission in the community. In this study, we developed the InnowaveDX MTB/RIF (InnowaveDX) to detect Mycobacterium tuberculosis (MTB) and rifampicin resistance simultaneously. A prospective multicentre study was conducted to evaluate the diagnostic performance of InnowaveDX for the detection MTB in sputum samples as compared with Xpert and culture. The calculated limit of detection (LOD) for InnowaveDX was 9.6 CFU/ml for TB detection and 374.9 CFU/ml for RIF susceptibility. None of the other bacteria tested produced signals that fulfilled the positive TB criteria, demonstrating a species-specificity of InnowaveDX. Then 951 individuals were enrolled at 7 hospitals, of which 607 were definite TB cases with positive culture and/or Xpert results, including 354 smear-positive and 253 smear-negative cases. InnowaveDX sensitivity was 92.7% versus bacteriologically TB standard. Further follow-up revealed that 61 (91.0%) out of 67 false-positive patients with no bacteriological evidence met the criteria of clinically diagnosed TB. Among 125 RIF-resistant TB patients diagnosed by Xpert, 108 cases were correctly identified by InnowaveDX, yielding a sensitivity of 86.4%. Additionally, the proportion of very low bacterial load in the discordant susceptibility group was significantly higher than in the concordant susceptibility group (P = 0.029). To conclude, we have developed a novel molecular diagnostic with promising detection capabilities of TB and RIF susceptibility. In addition, the discordant RIF susceptibility results between InnowaveDX and Xpert are more frequently observed in samples with very low bacterial load. |
| first_indexed | 2024-03-11T16:35:29Z |
| format | Article |
| id | doaj.art-bd6a79766244487280e1cfb05023f605 |
| institution | Directory Open Access Journal |
| issn | 2222-1751 |
| language | English |
| last_indexed | 2024-03-11T16:35:29Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Emerging Microbes and Infections |
| spelling | doaj.art-bd6a79766244487280e1cfb05023f6052023-10-23T17:36:55ZengTaylor & Francis GroupEmerging Microbes and Infections2222-17512023-12-0112110.1080/22221751.2022.2151382Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre studyYunfeng Deng0Zichun Ma1Biyi Su2Guanghong Bai3Jianhua Pan4Quan Wang5Long Cai6Yanhua Song7Yuanyuan Shang8Pinyun Ma9Jing Li10Qianxuan Zhou11Gulibike Mulati12Dapeng Fan13Shanshan Li14Yaoju Tan15Yu Pang16Katharine Hsu International Research Center of Human Infectious Diseases, Shandong Public Health Clinical Center Affiliated to Shandong University, Jinan, People’s Republic of ChinaDepartment of Bacteriology and Immunology, Beijing Key Laboratory on Drug-Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaDepartment of Clinical Laboratory, Guangzhou Chest Hospital, Guangzhou, People’s Republic of ChinaDepartment of Clinical Laboratory, Shanxi Provincial Tuberculosis Hospital, Xi’an, People’s Republic of ChinaDepartment of Clinical Laboratory, Changsha Central Hospital, Changsha, People’s Republic of ChinaDepartment of Clinical Laboratory, The Eighth Affiliated Hospital of Xinjiang Medical University, Urumqi, People’s Republic of ChinaDepartment of Clinical Laboratory, Hangzhou Red Cross Hospital, Hangzhou, People’s Republic of ChinaDepartment of Tuberculosis, Beijing Key Laboratory on Drug-Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaDepartment of Bacteriology and Immunology, Beijing Key Laboratory on Drug-Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaDepartment of Clinical Laboratory, Guangzhou Chest Hospital, Guangzhou, People’s Republic of ChinaDepartment of Clinical Laboratory, Shanxi Provincial Tuberculosis Hospital, Xi’an, People’s Republic of ChinaDepartment of Clinical Laboratory, Changsha Central Hospital, Changsha, People’s Republic of ChinaDepartment of Clinical Laboratory, The Eighth Affiliated Hospital of Xinjiang Medical University, Urumqi, People’s Republic of ChinaDepartment of Clinical Laboratory, Hangzhou Red Cross Hospital, Hangzhou, People’s Republic of ChinaDepartment of Bacteriology and Immunology, Beijing Key Laboratory on Drug-Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaDepartment of Clinical Laboratory, Guangzhou Chest Hospital, Guangzhou, People’s Republic of ChinaDepartment of Bacteriology and Immunology, Beijing Key Laboratory on Drug-Resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis & Thoracic Tumor Research Institute, Beijing, People’s Republic of ChinaABSTRACTEarly and accurate diagnosis of tuberculosis (TB) is necessary to initiate proper therapy for the benefit of the patients and to prevent disease transmission in the community. In this study, we developed the InnowaveDX MTB/RIF (InnowaveDX) to detect Mycobacterium tuberculosis (MTB) and rifampicin resistance simultaneously. A prospective multicentre study was conducted to evaluate the diagnostic performance of InnowaveDX for the detection MTB in sputum samples as compared with Xpert and culture. The calculated limit of detection (LOD) for InnowaveDX was 9.6 CFU/ml for TB detection and 374.9 CFU/ml for RIF susceptibility. None of the other bacteria tested produced signals that fulfilled the positive TB criteria, demonstrating a species-specificity of InnowaveDX. Then 951 individuals were enrolled at 7 hospitals, of which 607 were definite TB cases with positive culture and/or Xpert results, including 354 smear-positive and 253 smear-negative cases. InnowaveDX sensitivity was 92.7% versus bacteriologically TB standard. Further follow-up revealed that 61 (91.0%) out of 67 false-positive patients with no bacteriological evidence met the criteria of clinically diagnosed TB. Among 125 RIF-resistant TB patients diagnosed by Xpert, 108 cases were correctly identified by InnowaveDX, yielding a sensitivity of 86.4%. Additionally, the proportion of very low bacterial load in the discordant susceptibility group was significantly higher than in the concordant susceptibility group (P = 0.029). To conclude, we have developed a novel molecular diagnostic with promising detection capabilities of TB and RIF susceptibility. In addition, the discordant RIF susceptibility results between InnowaveDX and Xpert are more frequently observed in samples with very low bacterial load.https://www.tandfonline.com/doi/10.1080/22221751.2022.2151382Tuberculosismolecular diagnosisrpoBrifampicinGeneXpertInnowaveDX |
| spellingShingle | Yunfeng Deng Zichun Ma Biyi Su Guanghong Bai Jianhua Pan Quan Wang Long Cai Yanhua Song Yuanyuan Shang Pinyun Ma Jing Li Qianxuan Zhou Gulibike Mulati Dapeng Fan Shanshan Li Yaoju Tan Yu Pang Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study Emerging Microbes and Infections Tuberculosis molecular diagnosis rpoB rifampicin GeneXpert InnowaveDX |
| title | Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study |
| title_full | Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study |
| title_fullStr | Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study |
| title_full_unstemmed | Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study |
| title_short | Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study |
| title_sort | accuracy of the innowavedx mtb rif test for detection of mycobacterium tuberculosis and rifampicin resistance a prospective multicentre study |
| topic | Tuberculosis molecular diagnosis rpoB rifampicin GeneXpert InnowaveDX |
| url | https://www.tandfonline.com/doi/10.1080/22221751.2022.2151382 |
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