Loading…
PA-583 Revolutionising tuberculosis treatment response monitoring and developing research capacity in Africa: progress and potential of the tuberculosis molecular bacterial load assay
BackgroundTuberculosis (TB) treatment is long and complex. Here we summarise data from EDCTP-funded studies of the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) as a TB treatment monitoring tool.MethodsTreatment naïve participants from four Sub-Saharan African countries were assessed for TB...
Saved in:
Published in: | BMJ global health 2023-12, Vol.8 (Suppl 10), p.A99-A99 |
---|---|
Main Authors: | , , , , , , , , , , , , , , , , , , , |
Format: | Article |
Language: | English |
Subjects: | |
Online Access: | Request full text |
Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
cited_by | |
---|---|
cites | |
container_end_page | A99 |
container_issue | Suppl 10 |
container_start_page | A99 |
container_title | BMJ global health |
container_volume | 8 |
creator | Sabiiti, Wilber Musisi, Emmanuel Mtafya, Bariki Mbelele, Peter Azam, Khalide Ntinginya, Nyanda Elias Kuchaka, Davis Kamdolozi, Mercy Khosa, Celso Ssengooba, Willy Rachow, Andrea Henreich, Norbert Sloan, Derek J Joloba, Moses Davies, Gerry Aarnouste, Rob Boeree, Martin Hoelscher, Michael Kibiki, Gibson Sammy Gillespie, Stephen H |
description | BackgroundTuberculosis (TB) treatment is long and complex. Here we summarise data from EDCTP-funded studies of the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) as a TB treatment monitoring tool.MethodsTreatment naïve participants from four Sub-Saharan African countries were assessed for TB diagnosis and treatment response using TB-MBLA compared to liquid culture (MGIT) and other standard-of-care tests. ResultsDiagnostic accuracy assessment using MGIT as gold standard showed TB-MBLA sensitivity, specificity, positive-and-negative-predictive values were 99%, 91%, 92% and 99% respectively among presumptive TB cases. TB-MBLA turn-around-time (clinic-laboratory-clinic) was 6log10eCFU/mL, was associated with failure to convert to negative by month-2 of treatment. Resolution of TB-MBLA-measured sputum bacillary load mirrored cough resolution, reduction of C-reactive protein levels in blood and correlated with MGIT culture time-to-positivity (Spearmans r= -0.5, p500 clinical/laboratory scientists trained in principles of molecular diagnostic development and implementation globally.ConclusionThe data shows that TB-MBLA is a robust assay for TB treatment response monitoring and anti-TB drug development. It has contributed to research capacity building across Africa and beyond. |
doi_str_mv | 10.1136/bmjgh-2023-EDC.241 |
format | article |
fullrecord | <record><control><sourceid>proquest_9YT</sourceid><recordid>TN_cdi_proquest_journals_2903213139</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2903213139</sourcerecordid><originalsourceid>FETCH-LOGICAL-b1111-b4f9df15f2817e92f26a20ce6275242836ae13718bbfd36f7e56bfff2da7473</originalsourceid><addsrcrecordid>eNpVkc1KxDAQgIMguKz7Ap4Cnrvmp21ab8u6_sCCot5L0k52u7RNTdIFb158KF_HJzHdFcQ5zGTgy0zIh9AFJXNKeXql2t1mGzHCeLS6Wc5ZTE_QhJEkj0ROsjM0c25HCKEiJJJO0NfTIkoy_v3x-Qx70wy-Nl3t6m6D_aDAlkNjXO2wtyB9C53HFlxvOge4DaA3dkRlV-EK9tCYfmwDAtKWW1zKXpa1f8d1hxfa1qW8xr01mwC4w6Xe-DCzlg02Gvst_F_amgbCWVqsZOnBjlxjZIWlc_L9HJ1q2TiY_dYperldvS7vo_Xj3cNysY4UDRGpWOeVpolmGRWQM81SyUgJKRMJi1nGUwmUC5oppSueagFJqrTWrJIiFnyKLo9Tw7vfBnC-2JnBdmFhwXLCGeWU54GaH6nw_X8AJcXopDg4KUYnRXBSBCf8B-RwiJk</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2903213139</pqid></control><display><type>article</type><title>PA-583 Revolutionising tuberculosis treatment response monitoring and developing research capacity in Africa: progress and potential of the tuberculosis molecular bacterial load assay</title><source>BMJ Open Access Journals</source><creator>Sabiiti, Wilber ; Musisi, Emmanuel ; Mtafya, Bariki ; Mbelele, Peter ; Azam, Khalide ; Ntinginya, Nyanda Elias ; Kuchaka, Davis ; Kamdolozi, Mercy ; Khosa, Celso ; Ssengooba, Willy ; Rachow, Andrea ; Henreich, Norbert ; Sloan, Derek J ; Joloba, Moses ; Davies, Gerry ; Aarnouste, Rob ; Boeree, Martin ; Hoelscher, Michael ; Kibiki, Gibson Sammy ; Gillespie, Stephen H</creator><creatorcontrib>Sabiiti, Wilber ; Musisi, Emmanuel ; Mtafya, Bariki ; Mbelele, Peter ; Azam, Khalide ; Ntinginya, Nyanda Elias ; Kuchaka, Davis ; Kamdolozi, Mercy ; Khosa, Celso ; Ssengooba, Willy ; Rachow, Andrea ; Henreich, Norbert ; Sloan, Derek J ; Joloba, Moses ; Davies, Gerry ; Aarnouste, Rob ; Boeree, Martin ; Hoelscher, Michael ; Kibiki, Gibson Sammy ; Gillespie, Stephen H</creatorcontrib><description>BackgroundTuberculosis (TB) treatment is long and complex. Here we summarise data from EDCTP-funded studies of the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) as a TB treatment monitoring tool.MethodsTreatment naïve participants from four Sub-Saharan African countries were assessed for TB diagnosis and treatment response using TB-MBLA compared to liquid culture (MGIT) and other standard-of-care tests. ResultsDiagnostic accuracy assessment using MGIT as gold standard showed TB-MBLA sensitivity, specificity, positive-and-negative-predictive values were 99%, 91%, 92% and 99% respectively among presumptive TB cases. TB-MBLA turn-around-time (clinic-laboratory-clinic) was <24h compared to 5–42 days of MGIT culture. 450 participants were assessed for treatment response across four studies. The pre-treatment bacillary load across cohorts was 5.33+1.33log10eCFU/mL which was cleared to zero in over 95% of the participants by month-6 of treatment. TB-MBLA revealed early bacillary load clearance in 7% (32/450) participants who achieved a stable negative TB-MBLA result by week-2 of treatment and was faster than MGIT to identify participants at a risk of disease relapse. High pre-treatment bacillary load =/>6log10eCFU/mL, was associated with failure to convert to negative by month-2 of treatment. Resolution of TB-MBLA-measured sputum bacillary load mirrored cough resolution, reduction of C-reactive protein levels in blood and correlated with MGIT culture time-to-positivity (Spearmans r= -0.5, p<0.0001) during treatment. Like MGIT, TB-MBLA demonstrated that regimens containing rifampicin-35mg/kg and rifampicin-20mg/kg-400mg-moxifloxacin cleared TB bacteria significantly faster than the standard-of-care regimen by month-2 of treatment, p=0.049 and p=0.008 respectively in DS-TB, and highlighted efficacy of bedaquiline-containing all oral regimen for DR-TB treatment. This work produced 5 African PhD graduates plus >500 clinical/laboratory scientists trained in principles of molecular diagnostic development and implementation globally.ConclusionThe data shows that TB-MBLA is a robust assay for TB treatment response monitoring and anti-TB drug development. It has contributed to research capacity building across Africa and beyond.</description><identifier>EISSN: 2059-7908</identifier><identifier>DOI: 10.1136/bmjgh-2023-EDC.241</identifier><language>eng</language><publisher>London: BMJ Publishing Group Ltd</publisher><subject>Abstracts of Poster and e-Poster Presentations ; Bacterial infections ; Medical research ; Medical treatment ; Tuberculosis</subject><ispartof>BMJ global health, 2023-12, Vol.8 (Suppl 10), p.A99-A99</ispartof><rights>Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.</rights><rights>2023 Author(s) (or their employer(s)) 2023. No commercial re-use. See rights and permissions. Published by BMJ.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://gh.bmj.com/content/8/Suppl_10/A99.1.full.pdf$$EPDF$$P50$$Gbmj$$H</linktopdf><linktohtml>$$Uhttps://gh.bmj.com/content/8/Suppl_10/A99.1.full$$EHTML$$P50$$Gbmj$$H</linktohtml><link.rule.ids>314,780,784,27924,27925,55350,77660,77686</link.rule.ids><linktorsrc>$$Uhttps://gh.bmj.com/content/8/Suppl_10/A99.1.full$$EView_record_in_BMJ_Publishing_Group_Ltd$$FView_record_in_$$GBMJ_Publishing_Group_Ltd</linktorsrc></links><search><creatorcontrib>Sabiiti, Wilber</creatorcontrib><creatorcontrib>Musisi, Emmanuel</creatorcontrib><creatorcontrib>Mtafya, Bariki</creatorcontrib><creatorcontrib>Mbelele, Peter</creatorcontrib><creatorcontrib>Azam, Khalide</creatorcontrib><creatorcontrib>Ntinginya, Nyanda Elias</creatorcontrib><creatorcontrib>Kuchaka, Davis</creatorcontrib><creatorcontrib>Kamdolozi, Mercy</creatorcontrib><creatorcontrib>Khosa, Celso</creatorcontrib><creatorcontrib>Ssengooba, Willy</creatorcontrib><creatorcontrib>Rachow, Andrea</creatorcontrib><creatorcontrib>Henreich, Norbert</creatorcontrib><creatorcontrib>Sloan, Derek J</creatorcontrib><creatorcontrib>Joloba, Moses</creatorcontrib><creatorcontrib>Davies, Gerry</creatorcontrib><creatorcontrib>Aarnouste, Rob</creatorcontrib><creatorcontrib>Boeree, Martin</creatorcontrib><creatorcontrib>Hoelscher, Michael</creatorcontrib><creatorcontrib>Kibiki, Gibson Sammy</creatorcontrib><creatorcontrib>Gillespie, Stephen H</creatorcontrib><title>PA-583 Revolutionising tuberculosis treatment response monitoring and developing research capacity in Africa: progress and potential of the tuberculosis molecular bacterial load assay</title><title>BMJ global health</title><addtitle>BMJ Glob Health</addtitle><description>BackgroundTuberculosis (TB) treatment is long and complex. Here we summarise data from EDCTP-funded studies of the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) as a TB treatment monitoring tool.MethodsTreatment naïve participants from four Sub-Saharan African countries were assessed for TB diagnosis and treatment response using TB-MBLA compared to liquid culture (MGIT) and other standard-of-care tests. ResultsDiagnostic accuracy assessment using MGIT as gold standard showed TB-MBLA sensitivity, specificity, positive-and-negative-predictive values were 99%, 91%, 92% and 99% respectively among presumptive TB cases. TB-MBLA turn-around-time (clinic-laboratory-clinic) was <24h compared to 5–42 days of MGIT culture. 450 participants were assessed for treatment response across four studies. The pre-treatment bacillary load across cohorts was 5.33+1.33log10eCFU/mL which was cleared to zero in over 95% of the participants by month-6 of treatment. TB-MBLA revealed early bacillary load clearance in 7% (32/450) participants who achieved a stable negative TB-MBLA result by week-2 of treatment and was faster than MGIT to identify participants at a risk of disease relapse. High pre-treatment bacillary load =/>6log10eCFU/mL, was associated with failure to convert to negative by month-2 of treatment. Resolution of TB-MBLA-measured sputum bacillary load mirrored cough resolution, reduction of C-reactive protein levels in blood and correlated with MGIT culture time-to-positivity (Spearmans r= -0.5, p<0.0001) during treatment. Like MGIT, TB-MBLA demonstrated that regimens containing rifampicin-35mg/kg and rifampicin-20mg/kg-400mg-moxifloxacin cleared TB bacteria significantly faster than the standard-of-care regimen by month-2 of treatment, p=0.049 and p=0.008 respectively in DS-TB, and highlighted efficacy of bedaquiline-containing all oral regimen for DR-TB treatment. This work produced 5 African PhD graduates plus >500 clinical/laboratory scientists trained in principles of molecular diagnostic development and implementation globally.ConclusionThe data shows that TB-MBLA is a robust assay for TB treatment response monitoring and anti-TB drug development. It has contributed to research capacity building across Africa and beyond.</description><subject>Abstracts of Poster and e-Poster Presentations</subject><subject>Bacterial infections</subject><subject>Medical research</subject><subject>Medical treatment</subject><subject>Tuberculosis</subject><issn>2059-7908</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNpVkc1KxDAQgIMguKz7Ap4Cnrvmp21ab8u6_sCCot5L0k52u7RNTdIFb158KF_HJzHdFcQ5zGTgy0zIh9AFJXNKeXql2t1mGzHCeLS6Wc5ZTE_QhJEkj0ROsjM0c25HCKEiJJJO0NfTIkoy_v3x-Qx70wy-Nl3t6m6D_aDAlkNjXO2wtyB9C53HFlxvOge4DaA3dkRlV-EK9tCYfmwDAtKWW1zKXpa1f8d1hxfa1qW8xr01mwC4w6Xe-DCzlg02Gvst_F_amgbCWVqsZOnBjlxjZIWlc_L9HJ1q2TiY_dYperldvS7vo_Xj3cNysY4UDRGpWOeVpolmGRWQM81SyUgJKRMJi1nGUwmUC5oppSueagFJqrTWrJIiFnyKLo9Tw7vfBnC-2JnBdmFhwXLCGeWU54GaH6nw_X8AJcXopDg4KUYnRXBSBCf8B-RwiJk</recordid><startdate>20231217</startdate><enddate>20231217</enddate><creator>Sabiiti, Wilber</creator><creator>Musisi, Emmanuel</creator><creator>Mtafya, Bariki</creator><creator>Mbelele, Peter</creator><creator>Azam, Khalide</creator><creator>Ntinginya, Nyanda Elias</creator><creator>Kuchaka, Davis</creator><creator>Kamdolozi, Mercy</creator><creator>Khosa, Celso</creator><creator>Ssengooba, Willy</creator><creator>Rachow, Andrea</creator><creator>Henreich, Norbert</creator><creator>Sloan, Derek J</creator><creator>Joloba, Moses</creator><creator>Davies, Gerry</creator><creator>Aarnouste, Rob</creator><creator>Boeree, Martin</creator><creator>Hoelscher, Michael</creator><creator>Kibiki, Gibson Sammy</creator><creator>Gillespie, Stephen H</creator><general>BMJ Publishing Group Ltd</general><general>BMJ Publishing Group LTD</general><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>20231217</creationdate><title>PA-583 Revolutionising tuberculosis treatment response monitoring and developing research capacity in Africa: progress and potential of the tuberculosis molecular bacterial load assay</title><author>Sabiiti, Wilber ; Musisi, Emmanuel ; Mtafya, Bariki ; Mbelele, Peter ; Azam, Khalide ; Ntinginya, Nyanda Elias ; Kuchaka, Davis ; Kamdolozi, Mercy ; Khosa, Celso ; Ssengooba, Willy ; Rachow, Andrea ; Henreich, Norbert ; Sloan, Derek J ; Joloba, Moses ; Davies, Gerry ; Aarnouste, Rob ; Boeree, Martin ; Hoelscher, Michael ; Kibiki, Gibson Sammy ; Gillespie, Stephen H</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-b1111-b4f9df15f2817e92f26a20ce6275242836ae13718bbfd36f7e56bfff2da7473</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Abstracts of Poster and e-Poster Presentations</topic><topic>Bacterial infections</topic><topic>Medical research</topic><topic>Medical treatment</topic><topic>Tuberculosis</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sabiiti, Wilber</creatorcontrib><creatorcontrib>Musisi, Emmanuel</creatorcontrib><creatorcontrib>Mtafya, Bariki</creatorcontrib><creatorcontrib>Mbelele, Peter</creatorcontrib><creatorcontrib>Azam, Khalide</creatorcontrib><creatorcontrib>Ntinginya, Nyanda Elias</creatorcontrib><creatorcontrib>Kuchaka, Davis</creatorcontrib><creatorcontrib>Kamdolozi, Mercy</creatorcontrib><creatorcontrib>Khosa, Celso</creatorcontrib><creatorcontrib>Ssengooba, Willy</creatorcontrib><creatorcontrib>Rachow, Andrea</creatorcontrib><creatorcontrib>Henreich, Norbert</creatorcontrib><creatorcontrib>Sloan, Derek J</creatorcontrib><creatorcontrib>Joloba, Moses</creatorcontrib><creatorcontrib>Davies, Gerry</creatorcontrib><creatorcontrib>Aarnouste, Rob</creatorcontrib><creatorcontrib>Boeree, Martin</creatorcontrib><creatorcontrib>Hoelscher, Michael</creatorcontrib><creatorcontrib>Kibiki, Gibson Sammy</creatorcontrib><creatorcontrib>Gillespie, Stephen H</creatorcontrib><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>BMJ global health</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext_linktorsrc</fulltext></delivery><addata><au>Sabiiti, Wilber</au><au>Musisi, Emmanuel</au><au>Mtafya, Bariki</au><au>Mbelele, Peter</au><au>Azam, Khalide</au><au>Ntinginya, Nyanda Elias</au><au>Kuchaka, Davis</au><au>Kamdolozi, Mercy</au><au>Khosa, Celso</au><au>Ssengooba, Willy</au><au>Rachow, Andrea</au><au>Henreich, Norbert</au><au>Sloan, Derek J</au><au>Joloba, Moses</au><au>Davies, Gerry</au><au>Aarnouste, Rob</au><au>Boeree, Martin</au><au>Hoelscher, Michael</au><au>Kibiki, Gibson Sammy</au><au>Gillespie, Stephen H</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>PA-583 Revolutionising tuberculosis treatment response monitoring and developing research capacity in Africa: progress and potential of the tuberculosis molecular bacterial load assay</atitle><jtitle>BMJ global health</jtitle><stitle>BMJ Glob Health</stitle><date>2023-12-17</date><risdate>2023</risdate><volume>8</volume><issue>Suppl 10</issue><spage>A99</spage><epage>A99</epage><pages>A99-A99</pages><eissn>2059-7908</eissn><abstract>BackgroundTuberculosis (TB) treatment is long and complex. Here we summarise data from EDCTP-funded studies of the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) as a TB treatment monitoring tool.MethodsTreatment naïve participants from four Sub-Saharan African countries were assessed for TB diagnosis and treatment response using TB-MBLA compared to liquid culture (MGIT) and other standard-of-care tests. ResultsDiagnostic accuracy assessment using MGIT as gold standard showed TB-MBLA sensitivity, specificity, positive-and-negative-predictive values were 99%, 91%, 92% and 99% respectively among presumptive TB cases. TB-MBLA turn-around-time (clinic-laboratory-clinic) was <24h compared to 5–42 days of MGIT culture. 450 participants were assessed for treatment response across four studies. The pre-treatment bacillary load across cohorts was 5.33+1.33log10eCFU/mL which was cleared to zero in over 95% of the participants by month-6 of treatment. TB-MBLA revealed early bacillary load clearance in 7% (32/450) participants who achieved a stable negative TB-MBLA result by week-2 of treatment and was faster than MGIT to identify participants at a risk of disease relapse. High pre-treatment bacillary load =/>6log10eCFU/mL, was associated with failure to convert to negative by month-2 of treatment. Resolution of TB-MBLA-measured sputum bacillary load mirrored cough resolution, reduction of C-reactive protein levels in blood and correlated with MGIT culture time-to-positivity (Spearmans r= -0.5, p<0.0001) during treatment. Like MGIT, TB-MBLA demonstrated that regimens containing rifampicin-35mg/kg and rifampicin-20mg/kg-400mg-moxifloxacin cleared TB bacteria significantly faster than the standard-of-care regimen by month-2 of treatment, p=0.049 and p=0.008 respectively in DS-TB, and highlighted efficacy of bedaquiline-containing all oral regimen for DR-TB treatment. This work produced 5 African PhD graduates plus >500 clinical/laboratory scientists trained in principles of molecular diagnostic development and implementation globally.ConclusionThe data shows that TB-MBLA is a robust assay for TB treatment response monitoring and anti-TB drug development. It has contributed to research capacity building across Africa and beyond.</abstract><cop>London</cop><pub>BMJ Publishing Group Ltd</pub><doi>10.1136/bmjgh-2023-EDC.241</doi><oa>free_for_read</oa></addata></record> |
fulltext | fulltext_linktorsrc |
identifier | EISSN: 2059-7908 |
ispartof | BMJ global health, 2023-12, Vol.8 (Suppl 10), p.A99-A99 |
issn | 2059-7908 |
language | eng |
recordid | cdi_proquest_journals_2903213139 |
source | BMJ Open Access Journals |
subjects | Abstracts of Poster and e-Poster Presentations Bacterial infections Medical research Medical treatment Tuberculosis |
title | PA-583 Revolutionising tuberculosis treatment response monitoring and developing research capacity in Africa: progress and potential of the tuberculosis molecular bacterial load assay |
url | http://sfxeu10.hosted.exlibrisgroup.com/loughborough?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-27T09%3A05%3A18IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_9YT&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=PA-583%E2%80%85Revolutionising%20tuberculosis%20treatment%20response%20monitoring%20and%20developing%20research%20capacity%20in%20Africa:%20progress%20and%20potential%20of%20the%20tuberculosis%20molecular%20bacterial%20load%20assay&rft.jtitle=BMJ%20global%20health&rft.au=Sabiiti,%20Wilber&rft.date=2023-12-17&rft.volume=8&rft.issue=Suppl%2010&rft.spage=A99&rft.epage=A99&rft.pages=A99-A99&rft.eissn=2059-7908&rft_id=info:doi/10.1136/bmjgh-2023-EDC.241&rft_dat=%3Cproquest_9YT%3E2903213139%3C/proquest_9YT%3E%3Cgrp_id%3Ecdi_FETCH-LOGICAL-b1111-b4f9df15f2817e92f26a20ce6275242836ae13718bbfd36f7e56bfff2da7473%3C/grp_id%3E%3Coa%3E%3C/oa%3E%3Curl%3E%3C/url%3E&rft_id=info:oai/&rft_pqid=2903213139&rft_id=info:pmid/&rfr_iscdi=true |