Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study
Early 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 re...
Gespeichert in:
Hauptverfasser: | , , , , , , , , , , , , , , , , |
---|---|
Format: | Dataset |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext bestellen |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | |
---|---|
container_issue | |
container_start_page | |
container_title | |
container_volume | |
creator | Deng, Yunfeng Ma, Zichun Su, Biyi Bai, Guanghong Pan, Jianhua Wang, Quan Cai, Long Song, Yanhua Shang, Yuanyuan Ma, Pinyun Li, Jing Zhou, Qianxuan Mulati, Gulibike Fan, Dapeng Li, Shanshan Tan, Yaoju Pang, Yu |
description | Early 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. |
doi_str_mv | 10.6084/m9.figshare.21804085 |
format | Dataset |
fullrecord | <record><control><sourceid>datacite_PQ8</sourceid><recordid>TN_cdi_datacite_primary_10_6084_m9_figshare_21804085</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>10_6084_m9_figshare_21804085</sourcerecordid><originalsourceid>FETCH-LOGICAL-d915-8c7407c081f7fd520990ed7be831bffe1048aaaf1d1775f0414e3e81e176e6953</originalsourceid><addsrcrecordid>eNo1kLFOwzAURbMwoMIfMLwfaGs3Tu2wlUKhEhUS6sAWvdjP1FJjR7ZTlJ_gm6GCTlc6ujrDKYo7zmZLpsS8q2fWfaYDRpotuGKCqeq6-F5pPUTUIwQL-UCw9T584YkeP2C3f5i_bzeQKWWwIYKhTDq74M_n3ahDizpTdEMHeWgp6uEYkkuA3kB0Frveaech0i_M6DXdA0IfQ-rPmhNBNxyz0-RzJEh5MONNcWXxmOj2fyfFfvO0X79MX9-et-vV69TUvJoqLQWTmilupTXVgtU1IyNbUiVvrSXOhEJEyw2XsrJMcEElKU5cLmlZV-WkEH9agxm1y9T00XUYx4az5lyr6ermUqu51Cp_AGMraYw</addsrcrecordid><sourcetype>Publisher</sourcetype><iscdi>true</iscdi><recordtype>dataset</recordtype></control><display><type>dataset</type><title>Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study</title><source>DataCite</source><creator>Deng, Yunfeng ; Ma, Zichun ; Su, Biyi ; Bai, Guanghong ; Pan, Jianhua ; Wang, Quan ; Cai, Long ; Song, Yanhua ; Shang, Yuanyuan ; Ma, Pinyun ; Li, Jing ; Zhou, Qianxuan ; Mulati, Gulibike ; Fan, Dapeng ; Li, Shanshan ; Tan, Yaoju ; Pang, Yu</creator><creatorcontrib>Deng, Yunfeng ; Ma, Zichun ; Su, Biyi ; Bai, Guanghong ; Pan, Jianhua ; Wang, Quan ; Cai, Long ; Song, Yanhua ; Shang, Yuanyuan ; Ma, Pinyun ; Li, Jing ; Zhou, Qianxuan ; Mulati, Gulibike ; Fan, Dapeng ; Li, Shanshan ; Tan, Yaoju ; Pang, Yu</creatorcontrib><description>Early 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.</description><identifier>DOI: 10.6084/m9.figshare.21804085</identifier><language>eng</language><publisher>Taylor & Francis</publisher><subject>Biological Sciences not elsewhere classified ; Cancer ; Computational Biology ; FOS: Biological sciences ; FOS: Health sciences ; Infectious Diseases ; Mathematical Sciences not elsewhere classified ; Medicine ; Microbiology ; Science Policy ; Space Science</subject><creationdate>2023</creationdate><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>781,1895</link.rule.ids><linktorsrc>$$Uhttps://commons.datacite.org/doi.org/10.6084/m9.figshare.21804085$$EView_record_in_DataCite.org$$FView_record_in_$$GDataCite.org$$Hfree_for_read</linktorsrc></links><search><creatorcontrib>Deng, Yunfeng</creatorcontrib><creatorcontrib>Ma, Zichun</creatorcontrib><creatorcontrib>Su, Biyi</creatorcontrib><creatorcontrib>Bai, Guanghong</creatorcontrib><creatorcontrib>Pan, Jianhua</creatorcontrib><creatorcontrib>Wang, Quan</creatorcontrib><creatorcontrib>Cai, Long</creatorcontrib><creatorcontrib>Song, Yanhua</creatorcontrib><creatorcontrib>Shang, Yuanyuan</creatorcontrib><creatorcontrib>Ma, Pinyun</creatorcontrib><creatorcontrib>Li, Jing</creatorcontrib><creatorcontrib>Zhou, Qianxuan</creatorcontrib><creatorcontrib>Mulati, Gulibike</creatorcontrib><creatorcontrib>Fan, Dapeng</creatorcontrib><creatorcontrib>Li, Shanshan</creatorcontrib><creatorcontrib>Tan, Yaoju</creatorcontrib><creatorcontrib>Pang, Yu</creatorcontrib><title>Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study</title><description>Early 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.</description><subject>Biological Sciences not elsewhere classified</subject><subject>Cancer</subject><subject>Computational Biology</subject><subject>FOS: Biological sciences</subject><subject>FOS: Health sciences</subject><subject>Infectious Diseases</subject><subject>Mathematical Sciences not elsewhere classified</subject><subject>Medicine</subject><subject>Microbiology</subject><subject>Science Policy</subject><subject>Space Science</subject><fulltext>true</fulltext><rsrctype>dataset</rsrctype><creationdate>2023</creationdate><recordtype>dataset</recordtype><sourceid>PQ8</sourceid><recordid>eNo1kLFOwzAURbMwoMIfMLwfaGs3Tu2wlUKhEhUS6sAWvdjP1FJjR7ZTlJ_gm6GCTlc6ujrDKYo7zmZLpsS8q2fWfaYDRpotuGKCqeq6-F5pPUTUIwQL-UCw9T584YkeP2C3f5i_bzeQKWWwIYKhTDq74M_n3ahDizpTdEMHeWgp6uEYkkuA3kB0Frveaech0i_M6DXdA0IfQ-rPmhNBNxyz0-RzJEh5MONNcWXxmOj2fyfFfvO0X79MX9-et-vV69TUvJoqLQWTmilupTXVgtU1IyNbUiVvrSXOhEJEyw2XsrJMcEElKU5cLmlZV-WkEH9agxm1y9T00XUYx4az5lyr6ermUqu51Cp_AGMraYw</recordid><startdate>20230102</startdate><enddate>20230102</enddate><creator>Deng, Yunfeng</creator><creator>Ma, Zichun</creator><creator>Su, Biyi</creator><creator>Bai, Guanghong</creator><creator>Pan, Jianhua</creator><creator>Wang, Quan</creator><creator>Cai, Long</creator><creator>Song, Yanhua</creator><creator>Shang, Yuanyuan</creator><creator>Ma, Pinyun</creator><creator>Li, Jing</creator><creator>Zhou, Qianxuan</creator><creator>Mulati, Gulibike</creator><creator>Fan, Dapeng</creator><creator>Li, Shanshan</creator><creator>Tan, Yaoju</creator><creator>Pang, Yu</creator><general>Taylor & Francis</general><scope>DYCCY</scope><scope>PQ8</scope></search><sort><creationdate>20230102</creationdate><title>Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study</title><author>Deng, Yunfeng ; Ma, Zichun ; Su, Biyi ; Bai, Guanghong ; Pan, Jianhua ; Wang, Quan ; Cai, Long ; Song, Yanhua ; Shang, Yuanyuan ; Ma, Pinyun ; Li, Jing ; Zhou, Qianxuan ; Mulati, Gulibike ; Fan, Dapeng ; Li, Shanshan ; Tan, Yaoju ; Pang, Yu</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-d915-8c7407c081f7fd520990ed7be831bffe1048aaaf1d1775f0414e3e81e176e6953</frbrgroupid><rsrctype>datasets</rsrctype><prefilter>datasets</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Biological Sciences not elsewhere classified</topic><topic>Cancer</topic><topic>Computational Biology</topic><topic>FOS: Biological sciences</topic><topic>FOS: Health sciences</topic><topic>Infectious Diseases</topic><topic>Mathematical Sciences not elsewhere classified</topic><topic>Medicine</topic><topic>Microbiology</topic><topic>Science Policy</topic><topic>Space Science</topic><toplevel>online_resources</toplevel><creatorcontrib>Deng, Yunfeng</creatorcontrib><creatorcontrib>Ma, Zichun</creatorcontrib><creatorcontrib>Su, Biyi</creatorcontrib><creatorcontrib>Bai, Guanghong</creatorcontrib><creatorcontrib>Pan, Jianhua</creatorcontrib><creatorcontrib>Wang, Quan</creatorcontrib><creatorcontrib>Cai, Long</creatorcontrib><creatorcontrib>Song, Yanhua</creatorcontrib><creatorcontrib>Shang, Yuanyuan</creatorcontrib><creatorcontrib>Ma, Pinyun</creatorcontrib><creatorcontrib>Li, Jing</creatorcontrib><creatorcontrib>Zhou, Qianxuan</creatorcontrib><creatorcontrib>Mulati, Gulibike</creatorcontrib><creatorcontrib>Fan, Dapeng</creatorcontrib><creatorcontrib>Li, Shanshan</creatorcontrib><creatorcontrib>Tan, Yaoju</creatorcontrib><creatorcontrib>Pang, Yu</creatorcontrib><collection>DataCite (Open Access)</collection><collection>DataCite</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Deng, Yunfeng</au><au>Ma, Zichun</au><au>Su, Biyi</au><au>Bai, Guanghong</au><au>Pan, Jianhua</au><au>Wang, Quan</au><au>Cai, Long</au><au>Song, Yanhua</au><au>Shang, Yuanyuan</au><au>Ma, Pinyun</au><au>Li, Jing</au><au>Zhou, Qianxuan</au><au>Mulati, Gulibike</au><au>Fan, Dapeng</au><au>Li, Shanshan</au><au>Tan, Yaoju</au><au>Pang, Yu</au><format>book</format><genre>unknown</genre><ristype>DATA</ristype><title>Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study</title><date>2023-01-02</date><risdate>2023</risdate><abstract>Early 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.</abstract><pub>Taylor & Francis</pub><doi>10.6084/m9.figshare.21804085</doi><oa>free_for_read</oa></addata></record> |
fulltext | fulltext_linktorsrc |
identifier | DOI: 10.6084/m9.figshare.21804085 |
ispartof | |
issn | |
language | eng |
recordid | cdi_datacite_primary_10_6084_m9_figshare_21804085 |
source | DataCite |
subjects | Biological Sciences not elsewhere classified Cancer Computational Biology FOS: Biological sciences FOS: Health sciences Infectious Diseases Mathematical Sciences not elsewhere classified Medicine Microbiology Science Policy Space Science |
title | Accuracy of the InnowaveDX MTB/RIF test for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre study |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-16T21%3A32%3A40IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-datacite_PQ8&rft_val_fmt=info:ofi/fmt:kev:mtx:book&rft.genre=unknown&rft.au=Deng,%20Yunfeng&rft.date=2023-01-02&rft_id=info:doi/10.6084/m9.figshare.21804085&rft_dat=%3Cdatacite_PQ8%3E10_6084_m9_figshare_21804085%3C/datacite_PQ8%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_id=info:pmid/&rfr_iscdi=true |